[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-tract-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-tract-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,68,0,25,[9,53,81,108,141,169,198,221,239,266,300,331,359,381,404,433,470,500,525,550,579,604,631,652,673],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100609951","phase-3-a-study-of-rilvegostomig-or-durvalumab-plus-chemotherapy-for-first-line-treatment-of-biliary-tract-cancer-artemide-biliary02-100609951",false,"NCT07221253","A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)","Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)","AB02","Key inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).\n* Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting\n* Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.\n* Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.\n* ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS \\> 1) over the previous 2 weeks prior to baseline at screening and prior to randomization.\n* Adequate bone marrow and organ function.\n\nKey exclusion Criteria:\n\n* Ampullary carcinoma\n* Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC.\n* Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms.\n* Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.\n* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n* Active or ongoing interstitial lung disease\u002Fpneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.","ALL","18 Years",{"count":21,"type":22},1100,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to measure the efficacy and safety of rilvegostomig with gemcitabine plus cisplatin vs. durvalumab with gemcitabine plus cisplatin as first line treatment for patients with advanced BTC.",[28],"Biliary Tract Cancer",[30,31,28,32,33,34,35,36,37,38,39],"Rilvegostomig","Durvalumab","Bispecific Antibody","PD-L1","TIGIT","Initially Unresectable","Recurrent","Intra-hepatic cholangiocarcinoma","Extra-hepatic cholangiocarcinoma","Gallbladder cancer","RECRUITING","2026-08-20",{"date":43,"type":44},"2026-08-21","ACTUAL",{"date":46,"type":44},"2025-12-04",{"date":48,"type":22},"2029-07-31",{"name":50,"class":51},"AstraZeneca","INDUSTRY",177,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100575644","phase-1-a-phase-1-study-of-lncb74-in-advanced-solid-tumors-100575644","NCT06774963","A Phase 1 Study of LNCB74 in Advanced Solid Tumors","A Phase 1, Open-label, Dose Escalation and Dose Expansion Study for LNCB74, a B7-H4 Targeted Antibody Drug Conjugate, as Monotherapy in Participants With Advanced Solid Tumors","LNCB74-01","Inclusion Criteria:\n\n1. The participant provides written informed consent\n2. ≥ 18 years of age on day of signing informed consent.\n3. Participant with histologically or cytologically confirmed diagnosis of advanced unresectable and\u002For metastatic solid tumors\n4. A male participant must agree to use contraception and refrain from sperm donation or expecting to father a child\n5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential\n6. Have measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology\n7. Able to provide tumor tissue sample.\n8. Willing to undergo fresh tumor biopsy at Screening and On-treatment if archival tissue not available\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n10. Life expectancy greater than or equal to 12 weeks as judged by the Investigator.\n11. Have adequate organ function\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to treatment.\n2. Has received prior investigational agents within 4 weeks prior to treatment.\n3. Has received anti-cancer chemotherapy (Immunotherapy (non-antibody-based therapy), retinoid therapy, hormonal therapy within 2 weeks prior to treatment.\n4. Has received antibody-based anti-cancer therapy within 4 weeks prior to treatment.\n5. Has received targeted agents and small molecules within 2 weeks or 5 half-lives, whichever is longer.\n6. Has received prior platinum-based chemotherapy and progressed within 4 weeks of initiating therapy (platinum-refractory disease)\n7. Has received an ADC with MMAE payload.\n8. Has received prior radiotherapy within 2 weeks of start of study treatment for focal radiation or within 4 weeks for wide-field radiotherapy\n9. Has received G-CSF or GM-CSF within 7 days prior to start of study treatment.\n10. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.\n11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n12. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n13. Has known active CNS metastases and\u002For carcinomatous meningitis\n14. Has severe hypersensitivity (≥ Grade 3), known allergy or reaction LNCB74 or any of its excipients.\n15. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n16. Has active ≥Grade 2 sensory or motor neuropathy.\n17. Has active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy or any clinically significant corneal disease.\n18. Has an active infection requiring systemic therapy.\n19. Any major surgery within 4 weeks of study drug administration.\n20. Toxicity (except for alopecia) related to prior anti-cancer therapy and\u002For surgery, unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.\n21. Prior organ or tissue allograft.\n22. Uncontrolled or significant cardiovascular disease\n23. Participants with serious or uncontrolled medical disorders.\n24. Participants who are on total parenteral nutrition (TPN)\n25. Participants with history of bowel obstruction within one month of screening\n26. Participants with history of significant ascites requiring paracentesis within 2 weeks of screening\n27. Has a known history of human immunodeficiency virus (HIV) infection with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count \\\u003C350 cells\u002Fµl\n28. Has known active Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection\n29. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study\n30. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study",{"count":62,"type":22},145,[64],"PHASE1","This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and \u002F or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.",[67,68,69,28,70,71],"Ovarian Cancer","Breast Cancer","Endometrial Cancer","Non-Small Cell Lung Cancer","Advanced or Metastatic Solid Tumors","2026-08-19",{"date":43,"type":44},{"date":75,"type":44},"2025-01-07",{"date":77,"type":22},"2026-12",{"name":79,"class":51},"NextCure, Inc.",14,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100551997","phase-3-phase-3-study-of-t-dxd-and-rilvegostomig-versus-soc-in-advanced-her2-expressing-biliary-tract-cancer-100551997","NCT06467357","Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer","DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer","DESTINY-BTC01","Key Inclusion Criteria:\n\n* Male and female patients must be at least 18 years of age at the time of signing the informed consent. Other age restrictions may apply as per local regulations.\n* Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Prior treatment in the perioperative and\u002For adjuvant setting is permissible provided there is \\> 3 months (90 days) between the end of adjuvant treatment and the diagnosis of locally advanced or metastatic disease.\n* Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.\n* Patients must provide an FFPE tumor sample that is no older than 3 years for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 status, and other correlatives.\n* Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (Randomized portion only)\n* WHO\u002FECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n* Adequate organ and bone marrow function within 14 days before randomization.\n* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential.\n* Minimum life expectancy of 12 weeks.\n\nKey Exclusion Criteria:\n\n* Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines.\n* Histologically confirmed ampullary carcinoma.\n* Any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the Investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results.\n* Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n* Medical history of myocardial infarction within 6 months before randomization\u002Fenrollment, symptomatic congestive heart failure (New York Heart Association Class II to IV), unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (\\\u003C 6 months) cardiovascular event including stroke.\n* Serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease); active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.\n* Active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\> 450 msec (males) based on average of the screening triplicate 12-lead ECG.\n* History of (non-infectious) ILD\u002Fpneumonitis, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion etc).\n* Prior pneumonectomy (complete).\n* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. Patients with prior cholangitis\u002Fbiliary tract infections\u002Fbiliary intervention (eg, stent, external drain) should have completed a full course of antibiotics prior to randomization.\n* Active primary immunodeficiency, known uncontrolled active HIV infection or HCV.\n* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected nonmelanoma skin cancer and curatively treated in situ disease. For certain participant populations, exceptions could also include carcinomas in-situ or Ta tumors treated with curative intent.\n* Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (Drainage and Cell free and Concentrated Ascites Reinfusion Therapy are not allowed within 2 weeks prior to screening assessment).\n* Any concurrent anticancer treatment without an adequate washout period prior to randomization. Concurrent use of hormonal therapy for non-cancer related conditions (eg, hormone replacement therapy) is allowed.\n* History of organ transplants or allogenic stem cell transplant.","99 Years",{"count":91,"type":22},620,[25],"The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.",[28],[28,96,97,98,99,30],"HER2","HER2 expressing BTC","Trastuzumab deruxtecan","T-DXd","2026-08-18",{"date":72,"type":44},{"date":103,"type":44},"2024-08-12",{"date":105,"type":22},"2029-05-16",{"name":50,"class":51},269,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":120,"conditions":121,"keywords":126,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},"100476843","phase-2-study-of-dato-dxd-as-monotherapy-and-in-combination-with-anti-cancer-agents-in-patients-with-advanced-solid-tumours-tropion-pantumor03-100476843","NCT05489211","Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)","A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced\u002FMetastatic Solid Tumours","Key Inclusion Criteria: There are additional substudy requirements not reflected here. This list is based solely on the master CSP\n\n* Male and female, ≥ 18 years\n* Documented advanced or metastatic malignancy\n* Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing\n* All participants must provide a tumour sample for tissue-based analysis\n* At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease\n* Adequate bone marrow reserve and organ function\n* Minimum life expectancy of 12 weeks\n* At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* All women of childbearing potential must have a negative serum pregnancy test documented during screening\n* Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.\n* Capable of giving signed informed consent\n* Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative\n\nKey Exclusion Criteria:\n\n* Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol\n* History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent\n* Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved\n* Irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator, for example hearing loss\n* Spinal cord compression or brain metastases unless treated\n* Leptomeningeal carcinomatosis\n* Clinically significant corneal disease\n* Active hepatitis or uncontrolled hepatitis B or C virus infection\n* Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms\n* Known HIV infection that is not well controlled\n* Known active tuberculosis infection\n* Mean resting corrected QTcF \\> 470 ms\n* In the judgement of the investigator, history of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP\n* In the judgement of the investigator, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives\n* Uncontrolled or significant cardiac diseases\n* History of non-infectious Interstitial lung disease (ILD)\u002Fpneumonitis, including radiation pneumonitis that required steroids\n* Has severe pulmonary function compromise\n* Prior exposure to chloroquine\u002Fhydroxychloroquine without an adequate treatment washout period\n* Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention\n* Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment\n* Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or to more than 30% of the bone marrow within ≤ 4 weeks before the first dose of study intervention\n* Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study\n* Prior treatment with TROP2-directed therapies or other antibody-drug conjugate (ADCs) with deruxtecan payload\n* Herbal or natural products intended as treatment or prophylaxis for any type of cancer that may interfere with the activity of the study intervention\n* Previous treatment in the present study\n* Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study\n* Severe hypersensitivity to Dato-DXd or any of the excipients, including but not limited to polysorbate 80 or other monoclonal antibodies\n* Involvement in the planning and\u002For conduct of the study\n* Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements\n* Females that are pregnant, breastfeeding, or planning to become pregnant\n* Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of Dato-DXd","130 Years",{"count":117,"type":22},454,[119],"PHASE2","TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced\u002FMetastatic Solid Tumours.",[69,122,123,67,124,125,28],"Gastric Cancer","Metastatic Castration-resistant Prostate Cancer","Colorectal Cancer","Urothelial Cancer",[127,128,129,130,131],"TROPION-PanTumor03","Datopotamab Deruxtecan (Dato-DXd)","Solid Tumours","Antibody-drug conjugate (ADC)","Trophoblast cell surface protein 2 (TROP2)","2026-08-12",{"date":134,"type":44},"2026-08-13",{"date":136,"type":44},"2022-09-06",{"date":138,"type":22},"2027-10-01",{"name":50,"class":51},96,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100439243","phase-1-ab122-platform-study-100439243","NCT04999761","AB122 Platform Study","Platform Study of AB122 Based Treatments in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Is male or female aged ≥ 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;\n* Has adequate organ function as defined by the following criteria:\n\n  • AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN\n  * T-Bil of ≤ 1.5 × ULN\n  * ANC ≥ 1500 \u002Fmm3 (ie, ≥ 1.5 × 109 \u002FL by International System of Units \\[SI\\]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor \\[G-CSF\\])\n  * Platelet count ≥ 100000 \u002Fmm3 (SI: ≥ 100 × 109 \u002FL) (excluding measurements obtained within 7 days after a transfusion of platelets)\n  * Hemoglobin value of ≥ 9.0 g\u002FdL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood\n* Has a life expectancy of at least 90 days;\n\nCohort A-1 and A-2\n\n* Japanese male and female;\n* Has a histologically or cytologically confirmed diagnosis of solid tumor;\n* Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment;\n\nCohort B-1\n\n* Has a histologically or cytologically confirmed diagnosis of PDAC;\n* Has disease progression after or intolerant to one prior systemic chemotherapy for advanced or metastatic disease\n\nCohort B-2\n\n* Has a histologically or cytologically confirmed diagnosis of CRC.\n* Has been received one regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the chemotherapy\n\nCohort B-3\n\n* Has a histologically or cytologically confirmed non-squamous NSCLC;\n* Has been received one or two regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the standard treatment\n* Has been most recently received regimen including an ICI (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies) and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotherapy followed by checkpoint inhibitor therapy), and all of the following criteria must be met:\n\n  * Received at least 2 doses at the most recent ICI therapy\n  * Radiographic complete response or partial response based on investigator assessment with ICI therapy\n  * Documented radiographic disease progression with above most recently received regimen\n\nCohort C-1\n\n* Has unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer as pathologically confirmed adenocarcinoma\n* Gastroesophageal junction cancer is defined as a tumor with an epicenter that is located within 2 cm proximal to and distal from the esophagogastric junction (the boundary of esophageal and gastric muscularis).\n* Has received 2-4 standard regimens listed below and has demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose (The patient is eligible if the treatment is discontinued owing to SAEs, allergic reactions, or neurotoxicities.):\n\n  * fluoropyrimidines and platinum\n  * taxane or irinotecan\n  * ramucirumab\n\nCohort C-2 - Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded)\n\n* RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy; Wild type is defined as v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) (exon 2, 3 and 4) and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type. \\[Mutant is defined as at least KRAS or NRAS mutant (any exon, any mutation)\\].\n* Has received at least 2 prior chemotherapy regimens for the treatment of advanced CRC and had demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose , or intolerance to their last regimen, and all of the following criteria must be met:\n\n  * Prior treatment regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody\n  * For RAS wild-type patients, an anti-EGFR monoclonal antibody must have included in addition to above\n\nCohort D-1\n\n* Has histologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory.\n\nCohort D-2\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease.\n\n  * Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-3\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease, or refractory or intolerant to at least 1 cycle of standard first-line therapy.\n\n  * Treatment discontinued due to intolerable toxicity or because the same drug cannot be re-treated before the disease progresses is considered as intolerable to the previous treatment.\n  * Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-4\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  • The confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.\n\n  • Patient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-5\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  * The confirmed status of the HPV in cancers of the mid-pharynx.\n  * Patient background such as CPS and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-6\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous NSCLC.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-7\n\n* Has histologically confirmed unresectable or advanced biliary tract cancer (intrahepatic bile duct, extrahepatic bile duct, gallbladder, or duodenal papillary region) with a diagnosis of adenocarcinoma or adenosquamous carcinoma.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-8\n\n* Has histologically confirmed unresectable or advanced pancreatic ductal adenocarcinoma (highly differentiated, moderately differentiated, or poorly differentiated).\n* No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-9 - Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\nThe confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.\n\nPatient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n\n\\- No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nTreatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort E-1\n\n* Has a histologically or cytologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory (except for tolerability part).\n* Has been received 1-4 regimen for advanced or metastatic disease\n* Has been received one regimen of ICI monotherapy or combination therapy (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies), and all of the following criteria must be met:\n\n  * Received at least 2 doses of the ICI therapy\n  * Documented radiographic disease progression with or after ICI therapy\n\nCohort E-2\n\n* Has a histologically or cytologically confirmed advanced or metastatic ASPS\n* Is male or female aged ≥ 16 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedure\n\nExclusion Criteria:\n\n* Clinically significant history or current evidence of cardiac arrhythmia and\u002For conduction abnormality: Any factor that can increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, etc.;\n* Treatment with any of the following within the specified time frame prior to the day on which study treatment is scheduled to be started:\n\n  * Major surgery within 4 weeks (the surgical incision should be fully healed prior to the day on which study treatment is scheduled to be started);\n  * Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks;\n  * Any anticancer therapy within 2 weeks;\n  * Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever shorter;\n* Unresolved toxicity of ≥ Grade 2 attributed to any prior therapies (excluding anemia, peripheral sensory neuropathy, alopecia and skin pigmentation);\n* A serious illness or medical condition(s) including, but not limited to, the following specific medical conditions:\n\n  * Known acute systemic infection;\n  * Known medical history of interstitial lung disease\u002F drug-induced interstitial lung disease\u002F radiation pneumonitis which required steroid treatment\u002F any evidence of clinically active interstitial lung disease;\n  * Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV, Appendix A) within the previous 6 months; if \\> 6 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms;\n  * Known severe chronic kidney disease;\n  * Known positivity of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody in baseline virus test. In addition, the patient who is known negative in HCV ribonucleic acid (RNA) is eligible, even if positive for HCV antibody;\n  * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment, or may interfere with the interpretation of study results, and in the judgment of the investigator or sub-investigator would make the patient inappropriate for entry into this study;\n* Previous or concurrent cancer that is distinct in primary disease or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia, or any cancer curatively treated \\> 5 years prior to the day on which study treatment is scheduled to be started;\n* WOCBP or male patients who do not agree to effective birth control during the following period\n\n  1. WOCBP patients: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n  2. Male patients with WOCBP partners: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n* Prior treatment with an anti-PD-L1 anti-PD-1, anti-CTLA-4, or other ICI or agonist as monotherapy or in combination (except for cohort B-3, C-1, D-1 tolerability part and E-1).\n* Has received a live vaccine within 30 days prior to study treatment including, but not limited to the following examples: measles, mumps, rubella, varicella-zoster, yellow fever, and BCG. The inoculation with inactivated vaccines for seasonal influenza is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 28 days by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to enrollment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient\\'s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. (eg, paresis of intestine, intestinal obstruction, unable to receive 5% dextrose in water \\[DW\\] in patients with diabetes mellitus, respiratory failure, renal failure, hepatic failure, cerebrovascular disorder, gastrointestinal ulcers that require transfusion or are hemorrhagic, and wounds\u002Fbone fractures associated with neovascularization during the healing process, accumulation of pleural within 2 weeks prior to enrollment, ascitic, or pericardial fluid requiring drainage)",{"count":149,"type":22},917,[64],"This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.",[153,154,124,155,122,156,157,158,28],"Advanced or Metastatic Solid Tumor","Pancreatic Ductal Adenocarcinoma","Non-small Cell Lung Cancer","Alveolar Soft Part Sarcoma","Esophageal Cancer","Head and Neck Cancer","2026-08-03",{"date":161,"type":44},"2026-08-05",{"date":163,"type":44},"2021-06-01",{"date":165,"type":22},"2027-06",{"name":167,"class":51},"Taiho Pharmaceutical Co., Ltd.",9,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":23,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},"100532986","phase-2-azd0901-in-participants-with-advanced-solid-tumours-expressing-claudin182-100532986","NCT06219941","AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2","A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)","The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria.\n\nMaster Inclusion Criteria applicable to all sub studies:\n\n* Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.\n* Participants who are CLDN18.2 positive.\n* Must have at least one measurable lesion according to RECIST v1.1.\n* ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.\n* Predicted life expectancy of ≥ 12 weeks.\n* Adequate organ and bone marrow function as defined by protocol.\n* Body weight \\> 35 kg.\n* Participants are willing to comply with contraception requirements.\n\nSub study 1 Specific Inclusion criteria:\n\n* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.\n* Advanced or metastatic GC\u002FGEJC.\n* Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nSub study 2 Specific Inclusion criteria:\n\n* Participants diagnosed with histologically confirmed metastatic or advanced PDAC.\n* Availability of an archival sample or a fresh tumour biopsy taken at screening.\n* No prior treatments for unresectable or metastatic disease. Prior neoadjuvant\u002Fadjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose.\n\nSub study 3 Specific Inclusion criteria\n\n* Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (NOTE: Ampullary cancers are not eligible).\n* Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nMaster Exclusion Criteria applicable to all sub studies:\n\n* Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.\n* Participants with clinically significant ascites that require drainage.\n* A history of drug-induced non-infectious ILD\u002Fpneumonitis.\n* Central nervous system metastases or CNS pathology.\n* Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.\n* History of another primary malignancy.\n* Prior exposure to any MMAE-based ADC.\n* Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.\n\nSub study 1 Specific Exclusion criteria:\n\n* Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC\u002FGEJC unless they have failed\u002Fnot tolerated\u002For are not eligible for standard anti-HER2 therapy, where available.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.\n* The use of concomitant medications known to prolong the QT\u002FQTc interval.\n\nSub study 2 Specific Exclusion criteria:\n\n* Known DPD enzyme deficiency based on local testing where testing is SoC.\n* Use of strong inhibitor or inducer of UGT1A1.\n* Use of strong inhibitors or inducers of CYP3A4.\n* Known homozygous for the UGT1A1\\*28 allele based on local testing where testing is SoC.\n\nSub study 3 Specific Exclusion criteria\n\n• Clinically significant biliary obstruction that has not resolved before enrollment.",{"count":177,"type":22},226,[119],"The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.",[122,181,28,154],"Gastroesophageal Junction Cancer",[183,184,185,28,186,187,188],"Gastric cancer","Gastroesophageal junction cancer","Pancreatic Ductal adenocarcinoma","Phase II","Claudin 18.2","AZD0901","2026-07-28",{"date":191,"type":44},"2026-07-29",{"date":193,"type":44},"2023-12-13",{"date":195,"type":22},"2027-06-28",{"name":50,"class":51},52,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100641255","phase-3-a-study-of-bl-m07d1-versus-physicians-choice-of-chemotherapy-in-patients-with-her2-expressing-locally-advanced-or-metastatic-biliary-tract-cancer-after-platinum-containing-chemotherapy-failure-100641255","NCT07606599","A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure","A Phase III Randomized Controlled Clinical Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Be ≥18 years and ≤75 years old on the day the trial participant signs the informed consent form;\n3. Have an expected survival time of ≥3 months;\n4. Have a histologically or cytologically confirmed pathological diagnosis of biliary tract cancer;\n5. Have locally advanced or metastatic biliary tract cancer;\n6. Have a known genetic mutation;\n7. Be suitable to receive the control arm regimen;\n8. Have at least one measurable lesion as defined by RECIST v1.1;\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n10. Have recovered from previous anti-tumor therapy to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n11. Have no severe cardiac dysfunction, with a left ventricular ejection fraction (LVEF) ≥50%;\n12. Meet the required organ function levels;\n13. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must be negative for pregnancy; they must be non-lactating. All enrolled trial participants should practice adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Received surgical treatment, radical radiotherapy, chemotherapy, etc., within 4 weeks prior to the first dose;\n2. Patients with locally advanced or metastatic biliary tract cancer who are suitable for receiving curative-intent local therapy;\n3. Previously treated with ADC drugs using camptothecin derivatives as the toxin;\n4. History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;\n5. Concomitant pulmonary disease resulting in severely impaired lung function;\n6. Prolonged QTc interval, complete left bundle branch block, etc.;\n7. Diagnosed with active malignant tumors within 3 years prior to study randomization;\n8. Hypertension inadequately controlled by two antihypertensive medications;\n9. Patients with poorly controlled blood glucose levels;\n10. History of interstitial lung disease (ILD) \u002F interstitial pneumonia, etc.;\n11. Patients with active central nervous system (CNS) metastases;\n12. Patients with a history of allergy to recombinant humanized antibodies or any excipient of BL-M07D1;\n13. History of autologous or allogeneic stem cell transplantation;\n14. Positive for human immunodeficiency virus (HIV) antibodies, active Hepatitis B virus infection, or active Hepatitis C virus infection;\n15. Occurrence of severe infection, etc., within 4 weeks prior to the first dose of the study drug;\n16. Patients with a prior history of severe biliary tract infection\u002Fbleeding and biliary fistula;\n17. Presence of large serous cavity effusions, or serous cavity effusions with symptoms, etc.;\n18. Receiving long-term systemic corticosteroid therapy (e.g., \\>10 mg\u002Fday of prednisone or equivalent) prior to randomization;\n19. History of severe neurological or psychiatric disorders;\n20. Occurrence of serious and non-healing wounds, ulcers, or bone fractures within 4 weeks prior to signing informed consent;\n21. Patients with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;\n22. Intestinal obstruction, Crohn's disease, ulcerative colitis, chronic diarrhea, etc.;\n23. Received other unapproved clinical study drugs or treatments within 4 weeks prior to study randomization;\n24. Patients who plan to receive or have received a live vaccine within 28 days prior to the first dose;\n25. Imaging findings indicate that the tumor has invaded or encased major blood vessels in the abdomen, chest, neck, or pharynx;\n26. Presence of other serious physical conditions, laboratory abnormalities, or poor compliance, etc., that may increase the risk of participating in the study, interfere with the study results, or make the patient unsuitable for participation in the study as judged by the investigator.","75 Years",{"count":207,"type":22},398,[25],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing locally advanced or metastatic biliary tract cancer after platinum-containing chemotherapy failure.",[28],"2026-07-23",{"date":213,"type":44},"2026-07-24",{"date":215,"type":44},"2026-07-07",{"date":217,"type":22},"2028-12",{"name":219,"class":51},"Sichuan Baili Pharmaceutical Co., Ltd.",2,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":205,"enrollmentInfo":228,"targetDuration":4,"studyType":23,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":237,"locationsCount":238},"100637627","phase-3-a-study-comparing-bl-b01d1-with-treatment-of-physicians-choice-in-patients-with-locally-advanced-or-metastatic-biliary-tract-cancer-after-failure-of-platinum-based-chemotherapypanku-btc01-100637627","NCT07582315","A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)","A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. No gender restriction, aged ≥18 years and ≤75 years;\n3. Expected survival time ≥3 months;\n4. Patients with locally advanced or metastatic biliary tract cancer;\n5. Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years, or fresh tissue samples;\n6. Must have at least one measurable lesion as defined by RECIST v1.1;\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n8. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n9. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;\n10. Organ function levels must meet the specified requirements;\n11. Urine protein ≤2+ or ≤1000 mg\u002F24h;\n12. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, with serum pregnancy testing excluding pregnancy, and they must be non-lactating; all enrolled patients (regardless of male or female) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Use of chemotherapy, targeted therapy, biological therapy, etc., within 4 weeks or 5 half-lives prior to randomization;\n2. Patients with locally advanced or metastatic biliary tract cancer who are suitable for curative local therapy;\n3. Prior use of ADC drugs using topoisomerase I inhibitors as the toxin, or prior treatment with ADC drugs targeting EGFR and\u002For HER3;\n4. History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening;\n5. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;\n6. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;\n7. Diagnosis of active malignancy within 3 years prior to randomization;\n8. Hypertension poorly controlled by two antihypertensive medications, history of hypertensive crisis or hypertensive encephalopathy;\n9. Poorly controlled blood glucose levels;\n10. History of non-infectious interstitial lung disease (ILD) treated with steroids, etc.;\n11. Concurrent pulmonary disease resulting in clinically severe respiratory impairment;\n12. Patients with active central nervous system metastases;\n13. Severe infection occurring within 4 weeks prior to randomization;\n14. Patients with large serous cavity effusions, symptomatic serous cavity effusions, or poorly controlled serous cavity effusions;\n15. Imaging findings indicating tumor invasion or encasement of major blood vessels in the abdomen, thorax, neck, or pharynx;\n16. Serious non-healing wounds, ulcers, or fractures within 4 weeks prior to signing the informed consent form;\n17. Clinically significant bleeding or obvious bleeding tendencies in trial participants within 4 weeks prior to signing the informed consent form;\n18. Patients with a history of allergy to recombinant humanized antibodies or to any excipient component of BL-B01D1;\n19. Positive for human immunodeficiency virus antibodies, active tuberculosis, active hepatitis B virus infection, or hepatitis C virus infection;\n20. History of severe neurological or psychiatric disorders;\n21. Trial participants planning to receive or having received a live vaccine within 28 days prior to randomization;\n22. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":229,"type":22},538,[25],"This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or metastatic biliary tract cancer who have failed prior platinum-based chemotherapy.",[28],{"date":213,"type":44},{"date":235,"type":44},"2026-06-29",{"date":217,"type":22},{"name":219,"class":51},1,{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":255,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100538673","phase-1-open-label-study-to-evaluate-bl-m07d1-in-her2-expressing-malignant-solid-tumors-100538673","NCT06293898","Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors","A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors","Inclusion Criteria:\n\nParticipants must meet all the following inclusion criteria to be eligible for participation in this study:\n\n1. Signed the informed consent form voluntarily and agreed to follow the program requirements.\n2. Either sex\n3. Age: ≥18 years\n4. Life expectancy of ≥3 months\n5. For Dose Escalation and Dose Finding: Documented locally advanced or metastatic HER2-expressing (IHC 1+ to 3+ and\u002For HER2 gene amplification or activating mutation \\[see Table 17-5\\] in tumor specimen by ISH or NGS) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lines of standard therapy, including adjuvant\u002Fneoadjuvant treatment, or whose cancer is considered refractory to the standard of care or for which no standard treatment is available, including:\n\n   1. Cohort 1: Participants with HER2 expression in endometrial cancers\n   2. Cohort 2: Participants with HER2 expression in cervical cancers\n   3. Cohort 3: Participants with HER2 expression in ovarian cancers, including fallopian tube cancer and primary peritoneal cancer\n   4. Cohort 4: Participants with HER2 expression in urothelial cancers\n   5. Cohort 5: Participants with HER2 expression in biliary tract cancers\n   6. Cohort 6: Participants with HER2 expression in breast cancer\n   7. Cohort 7: Participants with HER2 expression in lung cancer\n   8. Cohort 8: Participants with HER2 expression in gastric, esophageal, or gastroesophageal junction (GEJ) cancers\n   9. Cohort 9: Participants with HER2 expression in other solid tumors as approved by the medical monitor Note: For indications in which a HER2-directed therapy is approved, the approved treatment is recommended although not mandated, at the discretion of the investigator.\n6. Agree to provide most recent existing tumor samples (formalin-fixed paraffin-embedded \\[FFPE\\] tissue block or slides) from primary or metastatic sites for tissue-based IHC staining to centrally determine HER2 expression (see details in Section 7.1.1).\n\n   1. In dose escalation and dose finding: archival tissue or fresh biopsy. If no archival tissue is available or it is not possible to obtain a fresh tissue biopsy, medical monitor approval is required to screen participant;\n   2. In dose expansion: an FFPE block or slides from fresh biopsy or the most recent archival tissue is required.\n7. At least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) V1.1\n8. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1\n9. Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by the National Cancer Institute (NCI) CTCAE V5.0, except for alopecia and endocrinopathies controlled by replacement therapy that must be Grade ≤2\n10. No serious cardiac dysfunction, left ventricular ejection fraction ≥50%\n11. Adequate organ function before enrollment, defined as:\n\n    1. Marrow function: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet (PLT) count ≥100×10\\^9\n\n       \u002FL, hemoglobin (Hb) ≥9.0 g\u002FdL \\[blood transfusion, PLT transfusion, erythropoietin, hematopoiesis agents, and granulocyte colony-stimulating factor (G-CSF) use are not allowed 1 week prior to screening\\]\n    2. Hepatic function: Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (≤3×ULN for participants with Gilbert's syndrome or liver metastasis at baseline), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) without liver metastasis ≤3.0×ULN, AST and ALT with liver metastasis ≤5.0×ULN\n    3. Renal function:\n\n       1. In dose escalation and dose finding: Creatinine (Cr) clearance ≥50 mL\u002Fminute (Cockcroft-Gault equation) or estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73 m\\^2 (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n       2. In dose expansion: Cr clearance ≥40 mL\u002Fminute (Cockcroft-Gault equation) or eGFR ≥40 mL\u002Fmin\u002F1.73 m\\^2 (CKD-EPI equation)\n12. Coagulation parameters: International Normalized Ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless receiving anticoagulation therapy with prothrombin time and aPTT levels within the intended therapeutic range\n13. Urine protein ≤2+ or ≤1000 mg\u002F24 hours (in dose escalation and dose finding only)\n14. Sexually active fertile participants and their partners must agree to use highly effective methods of contraception (defined in Appendix D) during the course of the study and for a washout period after the last dose of study treatment (7 months for women of childbearing potential and 4 months for men). An additional contraceptive method, such as a barrier method (eg, condom), is recommended.\n15. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female participants are considered WOCBP unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\>45 years old in the absence of other biological or physiological causes). In addition, females \\\u003C55 years old must have a serum follicle stimulating hormone (FSH) level \\>40 mIU\u002FmL to confirm menopause. NOTE: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. Additional Inclusion Criteria for Dose Expansion\n16. For participants with urothelial carcinoma (Part A: Randomized Doses):\n\n    1. Histologically confirmed advanced or unresectable HER2-expressing (as defined in Inclusion Criterion #5) urothelial carcinoma of the upper or lower urinary tract, not amenable to curative surgery or radiation. Mixed histological types are allowed if urothelial is the primary histology; however, small cell histology is excluded.\n    2. Participants with progression or recurrence following receipt of an ADC (eg, enfortumab vedotin or disitamab vedotin) and anti-PD1\u002FPD-L1 therapy (either as a combination regimen or as separate lines of therapy) in the advanced or metastatic setting. Patients treated with enfortumab\u002Fpembrolizumab in the localized muscle invasive setting will be eligible. Prior platinum therapy is allowed but not required.\n\n    Participants should have no more than 3 prior lines of systemic cytotoxic therapy (eg, ADC, chemotherapy) in the advanced or metastatic setting.\n17. Multiple Indications (Part B: Basket Dosing):\n\n    Has documented locally advanced or metastatic HER2-expressing (as defined in Inclusion Criterion #5) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lines of standard therapy, including adjuvant\u002Fneoadjuvant treatment, or whose cancer is considered refractory to the standard of care or for which no standard treatment is available, including:\n    1. Participants with HER2 expression in endometrial cancer\n    2. Participants with HER2 expression in cervical cancer\n    3. Participants with HER2 expression in ovarian cancer, including fallopian tube cancer and primary peritoneal cancer\n    4. Participants with HER2 expression in breast cancer, status post-trastuzumab deruxtecan\n    5. Participants with HER2 expression in breast cancer, trastuzumab deruxtecan-naïve\n    6. Participants with HER2 expression in gastric, esophageal, or GEJ cancers\n18. Participants deemed at high-risk for infection, including those with an indwelling catheter or ostomy, must be willing to receive prophylactic G-CSF during their time on study (see Section 6.3.3.5).\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will not be eligible for participation in this study:\n\n1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration\n2. Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA)\n\n   ≥ Grade 2 heart failure at any time, or history of myocardial infarction or unstable angina pectoris within 6 months before enrollment.\n3. Participants with prolonged QT interval corrected Fridericia formula (\\[QTcF\\]\\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block\n4. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis, etc. Participants with skin diseases that do not require systemic treatment (such as vitiligo, psoriasis), well-controlled type 1 diabetes, or hypothyroidism are permitted. For autoimmune conditions that are active but stable and low grade on systemic therapy, discussion with the medical monitor is required prior to screening\n5. Participants with other prior malignancies except for: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years prior to screening\n6. Participants with poorly controlled hypertension by 2 types of antihypertensive drugs (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg)\n7. Participants with advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension, etc.\n8. Participants who have a history of noninfectious interstitial lung disease (ILD)\u002F pneumonitis that required treatment with steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n9. Participants with stroke or transient ischemic attack (TIA) within 6 months before enrollment\n10. Participants with a thromboembolic event (eg, deep vein thrombosis or pulmonary embolism) within 6 months before enrollment except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before enrollment\n11. Participants with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and\u002For carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Patients on low dose corticosteroids (\\\u003C10 mg prednisone or equivalent\u002Fday) may participate\n12. Participants with pre-existing Grade ≥2 peripheral neuropathy\n13. Participants who have a history of anaphylaxis or severe hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-M07D1\n14. Participants who are receiving treatment with systemic glucocorticoids \\>10 mg\u002Fday equivalent of prednisone, except for the treatment of chronic obstructive pulmonary disease, antiemetic, infusion reactions; however, treatment with low dose glucocorticoids (≤10 mg\u002Fday equivalent of prednisone) is permitted. The chronic use of topical, inhaled, and locally injected steroids is permitted\n15. Participants who have received treatment with anthracyclines with a cumulative dose exceeding 360 mg\u002Fm\\^2\n16. Participants with known human immunodeficiency virus (HIV) infection (HIV antibody positive). Participants who are HIV positive are allowed to participate if all the following criteria are met:\n\n    1. Undetectable HIV RNA and CD4 count ≥ 350 cells\u002FμL at screening;\n    2. No AIDS-defining opportunistic infection within 12 months prior to screening;\n    3. On stable antiretroviral therapy (ART) for at least 4 weeks prior to enrollment with projected continuation of ART as clinically indicated while on the study.\n17. Participants with active hepatitis B virus (HBV) infection (positive HBsAg test).\n\n    Participants with a chronic inactive HBV infection are eligible if all the following criteria are met:\n    1. Have an HBV DNA viral load \\\u003C 500 IU\u002FmL;\n    2. Have normal AST and ALT, OR if liver metastasis is present, have AST and ALT \\\u003C3×ULN which are not attributed to HBV infection;\n    3. Are on antiviral treatment, as clinically indicated.\n18. Participants with active hepatitis C virus (HCV) infection (HCV antibody positive and HCV RNA \\> the lower limit of detection). Participants with a positive anti-HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA\n19. Participants with known active tuberculosis\n20. Participants with active infections requiring IV antibiotic, antiviral, or antifungal treatment, such as severe pneumonia, bacteremia, sepsis, etc., within 1 week prior to first dose of study treatment. Participants on stable oral antimicrobials with no clinical or laboratory evidence of active infection are eligible\n21. Participants who are pregnant, breastfeeding, or planning to become pregnant during the study\n22. Other conditions that the investigator or sponsor believes are not suitable for participating in this clinical trial.\n23. For Dose Expansion Only: Prior treatment with any topoisomerase inhibitor ADC. If the topoisomerase I ADC is sacituzumab govitecan, prior discussion with the medical monitor is required for potential inclusion",{"count":247,"type":22},280,[64],"The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.",[69,251,67,252,28,68,253,122,254,157],"Cervical Cancer","Urothelial Carcinoma","Lung Cancer","Gastroesophageal-junction Cancer",[96],"2026-07-16",{"date":258,"type":44},"2026-07-20",{"date":260,"type":44},"2024-02-09",{"date":262,"type":22},"2029-04-15",{"name":264,"class":51},"SystImmune Inc.",17,{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":23,"phases":276,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":299},"100647693","phase-3-futibatinib-tas-120-in-patients-with-advanced-biliary-tract-cancer-100647693","NCT07710885","Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer","A Phase 3, Randomized-Controlled, Open-Label, Multi-Regional, International Study of Futibatinib (TAS-120) and Zimberelimab (AB122) in Combination With Gemcitabine Plus Cisplatin Versus Durvalumab or Pembrolizumab in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers","FOENIX-BTC","Inclusion Criteria:\n\n1. Has histologically confirmed unresectable or advanced biliary tract (i.e. intrahepatic bile duct, extrahepatic bile duct, or gallbladder) cancer that is adenocarcinoma or adenosquamous carcinoma;\n2. Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC);\n\n   * Adjuvant or neoadjuvant chemotherapy is not considered as prior treatment if more than 6 months have passed since its completion.\n3. Has radiographically measurable disease per RECIST v1.1.\n4. Has a tumor tissue sample available for biomarker analysis in a quantity sufficient.\n5. Has an ECOG PS of 0 or 1 before administration of study treatment; Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria.\n\nExclusion Criteria:\n\n1. History and\u002For current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;\n2. History and\u002For current evidence of clinically significant retinal disorder confirmed by retinal examination;\n3. Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib\n4. Has prior treatment with an anti-Programmed Death Ligand 1 (PD-L1), anti-Programmed Cell Death Protein 1 (PD-1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other immune checkpoint inhibitor (ICI) or agonist as monotherapy or in combination.\n\nHas known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.",{"count":275,"type":22},784,[25],"To compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with first-line advanced biliary tract cancer",[28],[280,281,282,283,284,285,286,31,287,288,289,290],"Futibatinib","Biliary Tract Cancer (BTC)","TAS-120","Zimberelimab","AB122","Gemcitabine","Cisplatin","Pembrolizumab","Phase 3","Fibroblast Growth Factor Receptor (FGFR)","Programmed Cell Death Protein 1 (PD-1)","2026-07-13",{"date":293,"type":44},"2026-07-17",{"date":295,"type":44},"2026-06-24",{"date":297,"type":22},"2031-12-31",{"name":167,"class":51},21,{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":310,"conditions":311,"keywords":312,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100537803","phase-3-efficacy-and-safety-of-zanidatamab-with-standard-of-care-therapy-against-standard-of-care-therapy-for-advanced-her2-positive-biliary-tract-cancer-100537803","NCT06282575","Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer","An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer","Inclusion Criteria\n\n1. Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC).\n2. Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.\n3. Received no more than 2 cycles of systemic therapy which is limited to Cisplatin and Gemcitabine (CisGem) with or without a PD-1\u002FL1 inhibitor (physician's choice of durvalumab or pembrolizumab, where approved under local regulations) for advanced unresectable or metastatic disease.\n4. HER2-positive disease (defined as IHC 3+; or IHC 2+\u002F ISH+) by IHC and in situ Hybridization (ISH) assay (in participants with IHC 2+ tumors) at a central laboratory on new biopsy tissue or archival tissue from the most recent biopsy.\n5. Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.\n6. Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific regulations).\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Adequate organ function\n9. Females of childbearing potential must have a negative pregnancy test result.\n10. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.\n\nExclusion Criteria\n\n1. Prior treatment with a HER2-targeted agent\n2. Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab\n3. The following BTC histologic subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region.\n4. Use of systemic corticosteroids.\n5. Brain metastases\n6. Severe chronic or active infections\n7. History of allogeneic organ transplantation.\n8. Active or prior autoimmune inflammatory conditions\n9. History of interstitial lung disease or non-infectious pneumonitis.\n10. Participation in another clinical trial with an investigational medicinal product within the last 3 months.\n11. Females who are breastfeeding\n12. Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.\n13. Use of phenytoin",{"count":308,"type":22},286,[25],"The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1\u002Fligand-1 (PD-1\u002FL1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.",[28],[313,314,315,316,317,318,319,320,321],"JZP598","ZW25","HER-2 positive BIliary Tract cancer","Gallbladder Cancer","Intrahepatic Cholangiocarcinoma (ICC)","Extrahepatic Cholangiocarcinoma (ECC)","Zanidatamab","HER-2 overexpression","HER-2 amplification",{"date":323,"type":44},"2026-07-14",{"date":325,"type":44},"2024-07-19",{"date":327,"type":22},"2030-04-01",{"name":329,"class":51},"Jazz Pharmaceuticals",185,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":205,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":238},"100643447","phase-1-hepatic-arterial-infusion-chemotherapy-plus-envafolimab-and-lenvatinib-for-first-line-unresectable-advanced-biliary-tract-cancer-100643447","NCT07636798","Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer","Safety and Efficacy of Hepatic Arterial Infusion Chemotherapy (GP Regimen) and Intra-arterial Infusion of Envafolimab Combined With Lenvatinib for Unresectable Advanced First-line Biliary Tract Cancer: A Multicenter, Phase Ib\u002FII, Single-arm Clinical Study","Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria:\n\n1. Age between 18 years and \\[missing value\\] years, inclusive.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n3. Histologically or cytologically confirmed biliary tract carcinoma, deemed unsuitable for radical surgical resection.\n4. At least one measurable lesion as determined by the investigator in accordance with mRECIST or RECIST version 1.1.\n5. Estimated life expectancy greater than 3 months.\n6. No prior systemic therapy or local anti-tumor treatment, except for surgery (biliary drainage is permitted).\n7. Patients who experience relapse more than 6 months after completion of postoperative adjuvant therapy may be enrolled.\n8. Child-Pugh score of \\[missing value\\] points.\n9. Adequate organ function to meet the criteria for chemotherapy:\n\n   1. Bone marrow function: absolute neutrophil count ≥ \\[missing value\\]\u002FL; platelet count ≥ \\[missing value\\]; hemoglobin ≥ \\[missing value\\];\n   2. Hepatic function: total bilirubin ≤ \\[missing value\\] × upper limit of normal (ULN); for patients without liver metastases, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ \\[missing value\\] × ULN; for patients with confirmed liver metastases, AST and ALT ≤ \\[missing value\\] × ULN;\n   3. Renal function: serum creatinine ≤ \\[missing value\\] × ULN; routine urinalysis showing urinary protein \\\u003C \\[missing value\\]; if baseline urinary protein is \\[missing value\\], a 24-hour urine collection must confirm total protein ≤ 1 g\u002F24 h;\n   4. Coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; for patients receiving anticoagulant therapy, PT must be within the therapeutic range intended for the anticoagulant used.\n10. Female patients must be postmenopausal or, if premenopausal, have a negative urine or serum pregnancy test; male patients must agree to use effective contraception or have undergone surgical sterilization during the trial and for 8 weeks following the final dose of the study drug.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be excluded:\n\n1. Known hypersensitivity to the investigational drug(s).\n2. Current participation in another interventional clinical trial, or receipt of any investigational drug or use of investigational device within 4 weeks prior to first dosing.\n3. History of malignancy outside the biliary tract within 5 years prior to first dosing, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has been completely resected.\n4. Previous treatment with immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).\n5. History of solid organ or hematopoietic stem cell transplantation.\n6. Any condition requiring systemic corticosteroids (equivalent to prednisone or above) or other immunosuppressive therapy within 14 days prior to randomization.\n7. Active autoimmune disease or history of autoimmune disease with potential for recurrence.\n8. Radiographic evidence of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), or prior noninfectious pneumonitis identified on screening chest computed tomography (CT).\n9. Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia.\n10. Severe chronic or active infection (including tuberculosis) requiring systemic (oral or intravenous) antibiotic therapy within 14 days prior to randomization.\n11. Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV-1\u002F2 antibody positive); untreated active Hepatitis B. \\*Note: Subjects with Hepatitis B meeting the following criteria are eligible: HBV viral load \\\u003C 2000 copies\u002FmL (200 IU\u002FmL) prior to the first dose, with anti-HBV therapy administered throughout the chemotherapy period to prevent viral reactivation. For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.\\* Patients with active Hepatitis C infection (HCV antibody positive and HCV-RNA above the lower limit of detection) are excluded.\n12. Concurrent participation in another therapeutic clinical trial.\n13. Presence of obstructive jaundice (enrollment permitted following active intervention such as biliary drainage or stenting and subsequent normalization of liver function).\n14. Meeting any of the following cardiovascular criteria:\n\n    1. New York Heart Association (NYHA) Class II or higher heart failure within 3 months prior to initiation of study treatment;\n    2. Major cardiovascular events including myocarditis, myocardial infarction, cerebrovascular events, unstable arrhythmia, or unstable angina within 6 months prior to initiation of study treatment;\n    3. Symptomatic pulmonary embolism within \\[missing value\\] months prior to randomization;\n    4. Known artery disease or left ventricular ejection fraction (LVEF) \\\u003C 40%.\n15. Lactating women.\n16. Women of childbearing potential unwilling to use contraception.\n17. Vulnerable populations other than elderly or illiterate individuals, including those with mental illness, cognitive impairment, or critical illness.\n18. Any other reason deemed by the investigator to render the subject unsuitable for study participation.",{"count":339,"type":22},20,[64,119],"Advanced biliary tract cancer has a poor prognosis and limited efficacy with current regimens. This multicenter single-arm phase Ib\u002FII trial explores the efficacy and safety of HAI-GP chemotherapy combined with intraoperative arterial envafolimab and lenvatinib as first-line therapy for unresectable BTC. It conducts dose exploration to confirm the optimal dosage and evaluates clinical outcomes, aiming to establish a better comprehensive treatment strategy.",[28],[344,345,346,347,348,349],"Biliary tract cancer","Phase I\u002FII","Immunotherapy,","Lenvatinib","Envafolimab Injection","Hepatic arterial infusion,","2026-07-09",{"date":291,"type":44},{"date":353,"type":22},"2026-06",{"date":355,"type":22},"2029-12",{"name":357,"class":358},"West China Hospital","OTHER",{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":380},"100549007","phase-1-a-clinical-study-of-mk-2870-alone-or-with-other-treatments-to-treat-gastrointestinal-cancers-mk-9999-02a-100549007","NCT06428409","A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)","A Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has one of the following cancers:\n\n  * Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer\n  * Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer\n  * Advanced and\u002For unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer\n  * Advanced and\u002For unresectable BTC and has not received prior therapy for the cancer\n* For participants who have received prior therapy for cancer: Has recovered from any side effects due to previous cancer treatment\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* History of severe eye disease\n* For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening",{"count":367,"type":22},220,[64,119],"Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:\n\n* About the safety of sacituzumab tirumotecan alone or with other treatments and if people tolerate it\n* How many people have the cancer respond (get smaller or go away) to treatment",[124,154,28],"2026-06-30",{"date":373,"type":44},"2026-07-01",{"date":375,"type":44},"2024-06-20",{"date":377,"type":22},"2029-10-16",{"name":379,"class":51},"Merck Sharp & Dohme LLC",55,{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":23,"phases":391,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":238},"100644797","clinical-utility-of-ctdna-in-detecting-resistance-mechanisms-and-delivering-precision-medicine-to-cancer-patients-100644797","NCT07673861","Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients","Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine: A Tumour Agnostic Study","CURTAIN","Inclusion Criteria\n\nAll cohorts:\n\n* Age ≥18 years old\n* Ability to provide written informed consent\n* Presence of metastatic or unresectable disease\n* Being reviewed and treated through medical oncology service at Royal Marsden Hospital\n\nCohort 1: Locally Advanced\u002FMetastatic NSCLC\n\n* Oncogene-addicted NSCLC (i.e. ESCAT Tier 1 oncogenic drivers: EGFR\u002FALK\u002FROS1\u002FRET\u002FMET\u002FBRAF\u002FNTRK\u002FHER2\u002FKRAS), AND\n* Progressive disease on targeted therapy (any line) within the 6 weeks prior to consent\n\nCohort 2: Locally Advanced\u002FMetastatic GIST\n\n* Locally advanced\u002Fmetastatic gastrointestinal stromal tumour (GIST), AND\n* Progressive disease on targeted therapy (any line) within the 6 weeks prior to consent\n\nCohort 3: Metastatic Colorectal Cancer\n\n• Metastatic colorectal cancer, left sided, RAS wild type, HER2 any status, AND\n\n* If HER2 negative or unknown: progressive disease on systemic anti-cancer therapy (SACT) with an anti-EGFR agent (e.g. cetuximab) within the 6 weeks prior to consent\n* If HER2 positive: progressive disease on first line systemic anti-cancer therapy (SACT) +\u002F- an anti-EGFR agent within the 6 weeks prior to consent\n\nCohort 4: Locally Advanced\u002FMetastatic BTC\n\n* Identified targetable mutation (IDH1 mutation\u002FHER2 amplification\u002FFGFR2 fusion or rearrangement\u002FNTRK fusion\u002FBRAF V600E mutation\u002FMMR deficiency \\[dMMR\\]), AND\n* Progressive disease on targeted therapy (any line) demonstrated within the 6 weeks prior to consent\n\nCohort 5: Advanced\u002FMetastatic ovarian cancer\n\n* Diagnosis of advanced\u002Fmetastatic high-grade ovarian cancer, AND\n* Known BRCA status, AND\n* Progressive disease on a PARP-inhibitor (with or without bevacizumab) following platinum-based therapy in the 1st line maintenance setting, within the 6 weeks prior to consent\n\nExclusion Criteria\n\nAll cohorts:\n\n* Medically unstable to commit to sampling required for the study\n* ECOG performance status ≥3",{"count":390,"type":22},100,[392],"NA","ctDNA stands for circulating tumour DNA. As ctDNA is released by tumour cells into the blood stream, taking a blood sample and analysing it for ctDNA, can provide a lot of useful information about a patient's cancer. In certain situations, ctDNA can be used to screen for or detect cancer early, to aid clinical decisions about which treatment to give a patient, to provide information about if a cancer has become resistant to treatment, or provide information about how much cancer may be left after treatment (residual disease).\n\nThe aim of this trial is to establish the clinical utility of implementing ctDNA testing in cancer patients with a view to enhance the delivery of personalised care within the National Health Service in the United Kingdom (UK).\n\nOne hundred patients will be recruited, with 20 from each of the following cancer types:\n\n* Non-small cell lung cancer\n* Gastrointestinal stromal tumours\n* Colorectal cancer\n* Biliary tract cancer\n* Ovarian cancer.\n\nPatients must be aged 18 or over, must have had progressive disease whilst receiving anti-cancer treatment, and must be being treated at The Royal Marsden.\n\nPatients will have a blood sample taken and analysed using the Marsden360 ctDNA test. The results of the test will be looked at by The Royal Marsden Genomic Tissue Advisory Board (GTAB), and for each individual patient, the GTAB will determine if having a ctDNA test helped to personalise their care by:\n\n* Aiding the identification of a genomically-matched standard of care therapy\n* Aiding the identification of a genomically-matched clinical trial (based in the UK)\n* Offering additional prognostic information not otherwise available through standard of care testing\n* Negating the need for a tissue biopsy.",[395,396,124,28,67],"Non Small Cell Lung Cancer","Gastrointestinal Stromal Tumor (GIST)",{"date":235,"type":44},{"date":399,"type":44},"2025-05-23",{"date":401,"type":22},"2026-12-31",{"name":403,"class":358},"Royal Marsden NHS Foundation Trust",{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":413,"phases":4,"briefSummary":414,"conditions":415,"keywords":417,"overallStatus":423,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":4},"100643924","study-of-occupational-risk-factors-for-biliary-and-pancreatic-cancers-100643924","NCT07668024","Study of Occupational Risk Factors for Biliary and Pancreatic Cancers","PANTOXBIL","Inclusion Criteria:\n\n* Cases :\n\n  * Patients included in the TEDOPAM or IMMUNOBIL trials\n  * Diagnosis of biliary tract or pancreatic cancer\n  * Completed and exploitable curriculum laboris\n* Controls :\n\n  * Subjects from the CHOPPI cohort\n  * Age ≥ 18 years\n  * No biliary tract or pancreatic cancer\n  * No known familial predisposition to biliary tract or pancreatic cancers\n  * No opposition to data reuse\n\nExclusion Criteria:\n\n* Incomplete or non-exploitable occupational history\n* Refusal of data reuse",{"count":412,"type":22},210,"OBSERVATIONAL","PANTOXBIL is a research project developed in the context of the increasing incidence of biliary tract and pancreatic cancers in France. Despite recent therapeutic advances, the prognosis of these cancers remains poor. Known risk factors do not fully explain the increase in incidence observed over recent decades. This suggests the possible role of emerging occupational and environmental risk factors, as reported in several epidemiological studies.\n\nThe PANTOXBIL study is based on the analysis of detailed curriculum laboris data (employment periods, occupations, tasks performed, and occupational exposures) collected during two multicenter phase II clinical trials, TEDOPAM and IMMUNOBIL, conducted between 2018 and 2021 in patients with pancreatic and biliary tract cancers.\n\nAn occupational exposure assessment was performed to calculate semi-quantitative cumulative exposure indices for each exposure or group of exposures for every participant. These indices will be compared with those of healthy controls from the CHOPPI cohort, initially designed to study occupational risk factors in COPD.\n\nPANTOXBIL is a matched case-control study based on sex, age, and smoking status. The aim is to compare cumulative occupational exposure indices between cases and controls in order to generate new hypotheses regarding occupational risk factors for biliary tract and pancreatic cancers.",[28,416],"Pancreatic Cancer",[418,419,420,421,422],"Biliopancreatic cancers","Occupational exposure","Cumulative exposure index","Curriculum laboris","Case-control study","NOT_YET_RECRUITING","2026-06-19",{"date":426,"type":44},"2026-06-25",{"date":428,"type":22},"2026-08",{"date":430,"type":22},"2026-09",{"name":432,"class":358},"Centre Hospitalier Intercommunal Creteil",{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":450,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":238},"100642684","phase-1-dual-target-her2cea-car-nk-cells-in-advanced-biliary-tract-cancer-100642684","NCT07641036","Dual-Target HER2\u002FCEA CAR-NK Cells in Advanced Biliary Tract Cancer","A Phase 1\u002F2, Open-Label, Biomarker-Selected Study of Allogeneic Dual-Target HER2\u002FCEACAM5 Chimeric Antigen Receptor Natural Killer Cells (EB-HC01) in Participants With Unresectable or Metastatic Cholangiocarcinoma and Other Biliary Tract Cancers","DUET-BTC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable, recurrent, or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma.\n* Disease progression after at least 1 prior gemcitabine\u002Fplatinum-containing regimen in the advanced setting; prior durvalumab and prior HER2-targeted therapy are allowed.\n* Central biomarker confirmation of HER2 positivity (IHC 3+ or IHC 2+\u002FISH+ or ERBB2 amplification) and CEACAM5\u002FCEA positivity (membranous expression in \\>=20% of viable tumor cells by IHC).\n* At least 1 measurable lesion according to RECIST 1.1.\n* ECOG performance status 0-1.\n* Adequate marrow, renal, hepatic, and cardiac function as defined by the protocol.\n* Resolved biliary obstruction or stable internal\u002Fexternal drainage for \\>=7 days before lymphodepletion, with no active cholangitis.\n* Life expectancy \\>=12 weeks.\n* Willingness to provide archival or fresh tumor tissue and serial blood samples for central biomarker testing and correlative studies.\n* Agreement to use protocol-specified contraception\n\nExclusion Criteria:\n\n* Prior HER2-directed or CEA-directed gene-modified cell therapy.\n* Untreated or unstable CNS metastases or leptomeningeal disease.\n* Active uncontrolled infection, including uncontrolled cholangitis, sepsis, or clinically significant uncontrolled hepatitis or HIV infection.\n* Ongoing systemic immunosuppression greater than 10 mg\u002Fday prednisone equivalent within 7 days before lymphodepletion.\n* Clinically significant interstitial lung disease, uncontrolled heart failure, unstable arrhythmia, or recent myocardial infarction.\n* Child-Pugh B or C liver disease, hepatic encephalopathy, or clinically significant refractory ascites.\n* Prior allogeneic solid organ transplant or allogeneic stemcell transplant.\n* Active autoimmune disease requiring systemic therapy within the previous 2 years.\n* Pregnancy or breastfeeding.\n* Any condition that, in the investigator's judgment, would make lymphodepletion or EB-HC01 infusion unsafe or would interfere with protocol compliance.",{"count":442,"type":22},30,[64,119],"This example phase 1\u002F2, open-label, biomarker-selected study evaluates EB-HC01, an allogeneic dual-target CARNK product composed of a 1:1 mixture of HER2-CAR-NK and CEACAM5-CAR-NK cells, in adults with unresectable or metastatic cholangiocarcinoma or other biliary tract cancers after standard therapy. Part A determines safety, dose-limiting toxicities (DLTs), and the recommended phase 2 dose (RP2D) after reduced-intensity lymphodepletion. Part B evaluates preliminary anti-tumor activity, CAR-NK persistence, and biomarker-response associations.",[446,447,448,449,28],"Cholangiocarcinoma","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Gallbladder Carcinoma",[451,452,96,453,454,455,456,457,458,459,460],"CAR-NK","dual-target cell therapy","ERBB2","CEA","CEACAM5","cholangiocarcinoma","biliary tract cancer","allogeneic","off-the-shelf","adoptive cell therapy","2026-06-06",{"date":463,"type":44},"2026-06-11",{"date":465,"type":44},"2026-03-02",{"date":467,"type":22},"2028-10-17",{"name":469,"class":51},"Beijing Biotech",{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":477,"enrollmentInfo":478,"targetDuration":4,"studyType":23,"phases":480,"briefSummary":482,"conditions":483,"keywords":488,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":238},"100588144","early-phase-1-cdh17-car-t-therapy-in-advanced-malignant-solid-tumors-100588144","NCT06937567","CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors","Exploratory Study on the Safety and Preliminary Efficacy of UCLH80-1 Cells in Patients With CDH17-Positive Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Histopathologically confirmed malignant solid tumors, including but not limited to colorectal cancer, gastric cancer, pancreatic cancer, and biliary tract tumors.\n* Patients must have failed standard treatments, be intolerant to standard treatments, or lack effective treatment options.\n* At least one measurable lesion as defined by RECIST v1.1 criteria.\n* Tumor tissue must be available either from prior tumor biopsy or by providing new tumor specimens.\n* Tumor specimens must be confirmed as CDH17-positive by immunohistochemistry (IHC) or immunocytochemistry (ICC) staining.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Expected survival time ≥ 3 months.\n* Appropriate organ function: hematological: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹\u002FL. Hemoglobin (HGB) ≥ 80 g\u002FL; Platelet count (PLT) ≥ 75 × 10⁹\u002FL. Liver Function: aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3.0 × ULN (≤ 5.0 × ULN for patients with primary liver tumors or liver metastases); total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN for patients with primary liver tumors or liver metastases; ≤ 3 × ULN for Gilbert's syndrome with direct bilirubin ≤ 1.5 × ULN). Coagulation: international normalized ratio (INR) ≤ 1.5 × ULN (unless on therapeutic anticoagulants); activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (unless on therapeutic anticoagulants). Renal Function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL\u002Fmin (based on Cockcroft-Gault formula). Cardiac Function: left ventricular ejection fraction (LVEF) ≥ 50% (confirmed by echocardiography). Pulmonary Function: resting oxygen saturation (SpO₂) \\> 92% without supplemental oxygen.\n* Female participants of childbearing potential must have a negative pregnancy test.\n* Female participants of childbearing potential or male participants with partners of childbearing potential must agree to use effective contraception during the study and for 1 year after the final cell infusion.\n* Willingness to sign the informed consent form, demonstrating understanding of the study and agreement to comply with study procedures.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding.\n* Positive hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) with peripheral HBV DNA levels above the lower limit of detection.\n* Positive hepatitis C virus (HCV) antibody with peripheral HCV RNA levels above the lower limit of detection.\n* Positive HIV antibody.\n* Positive syphilis-specific and non-specific antibody tests.\n* Non-hematological toxicity from prior treatment (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) has not resolved to ≤ CTCAE grade 1 (except for hair loss and peripheral sensory neuropathy).\n* Prior allogeneic tissue or organ transplant (including bone marrow, stem cell, liver, kidney, etc.), except for transplants not requiring immunosuppression (e.g., corneal or hair transplantation).\n* Patients who have previously received CDH17 CAR-T therapy, except those who received CAR-T infusion within this study.\n* Underwent major surgery within 4 weeks prior to signing informed consent and has not fully recovered, or has a history of serious unresolved trauma.\n* Known central nervous system (CNS) metastases (with exceptions for asymptomatic brain metastases or stable clinical symptoms).\n* Severe active infections or pulmonary diseases requiring systemic corticosteroid treatment within 6 months prior to signing informed consent.\n* Symptomatic congestive heart failure (NYHA class II-IV), severe aortic stenosis, or symptomatic mitral stenosis.\n* ECG showing QTc \\> 450 ms or QTc \\> 480 ms with bundle branch block.\n* Uncontrolled hypertension (SBP ≥ 160 mmHg and\u002For DBP ≥ 100 mmHg).\n* Cerebrovascular accidents within 6 months prior to signing informed consent.\n* Active, chronic, or recurrent severe autoimmune diseases requiring immunosuppressive treatment (with exceptions).\n* Any form of primary or secondary immunodeficiency.\n* Risk of organ perforation or bleeding as judged by the investigator.\n* Severe systemic hypersensitivity reactions to study drugs\u002Fcomponents. - Received live attenuated vaccines within 4 weeks prior to signing informed consent.\n* Participated in another clinical study within 4 weeks prior to signing informed consent.\n* History of another malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer or in situ cancers.\n* Diagnosed with neuropsychiatric disorders or any condition deemed by the investigator as unsuitable for participation.","70 Years",{"count":479,"type":22},36,[481],"EARLY_PHASE1","The investigational product used in this study, UCLH801 cells, is a CAR-T cell therapy specifically targeting CDH17. The proposed indication includes CDH17-positive advanced solid tumors, such as but not limited to colorectal cancer, gastric cancer, pancreatic cancer, biliary tract tumors, neuroendocrine tumors, ovarian cancer, and lung cancer. The primary objective of this study is to evaluate the safety and tolerability of UCLH801 cells in patients with CDH17-positive advanced malignant solid tumors. The secondary objectives include assessing the preliminary efficacy of UCLH801 cells, their pharmacokinetics and pharmacodynamics in the body, and their immunogenicity.\n\nThis study aims to observe how the infusion of UCLH801 cells affects patients 's body, including any discomfort or changes in laboratory test results. Additionally, it will evaluate whether UCLH801 cells have any effect on tumor. Furthermore, the study will investigate how UCLH801 cells are metabolized; the mechanisms through which they exert their effects, and how to develops any immune response or rejection against UCLH801 cells.",[28,484,485,486,487],"Colorectal Carcinoma","Gastric Cancer, Metastatic","Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)","Multiple Cancer",[489,490],"CAR-T","CDH17","2026-05-20",{"date":493,"type":44},"2026-05-26",{"date":495,"type":44},"2024-12-26",{"date":497,"type":22},"2028-05-30",{"name":499,"class":358},"Zhejiang University",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":513,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":524},"100556792","phase-2-testing-ivonescimab-versus-folfox-in-advanced-biliary-tract-cancer-patients-100556792","NCT06529718","Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients","A Randomised, Phase II Trial to Evaluate the Efficacy of Ivonescimab, a PD 1\u002FVEGF Bispecific Antibody, Versus FOLFOX as Second Line Therapy for Locally Advanced\u002FMetastatic Biliary Cancers","SEVILLA","Inclusion Criteria:\n\n1. Signed a written informed consent form prior to any trial specific procedures.\n2. Histologically-proven intrahepatic cholangiocarcinoma, perihilar \u002F distal cholangiocarcinoma, or gallbladder carcinoma (ampullary carcinoma excluded).\n3. Locally advanced (non-resectable) or metastatic disease.\n4. Participated in the Screening phase of the SAFIR-ABC10 trial.\n5. Progression after first line standard of care (1L-SoC) regimen (CISGEM ± immunotherapy) as assessed by the investigator.\n6. Eligible for second-line treatment with FOLFOX.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Presence of at least one evaluable lesion according to RECIST v1.1.\n9. Age ≥18 years.\n10. Adequate bone marrow function: absolute neutrophil count (ANC) ≥2 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, and haemoglobin ≥9 g\u002FdL.\n\n    Note: Blood transfusion or growth factor therapy should not be performed within 7 days prior to the screening haematology analysis.\n11. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (≤3 x ULN for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 x ULN when documented liver metastasis).\n12. Adequate renal function: estimated creatinine clearance ≥50 mL\u002Fmin according to the Cockcroft-Gault formula, or estimated glomerular filtration rate value ≥50 mL\u002Fmin using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, and urine protein \\\u003C 2+ or 24 hour urine protein quantification \\\u003C 1.0 g.\n13. Coagulation: prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated PTT ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy,or prophylactic coagulation).\n14. Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥50% at baseline as determined by either echocardiogram or multigated acquisition (MUGA) scan.\n15. Documented virology status of hepatitis, as confirmed by screening hepatitis B virus (HBV) and hepatitis C virus (HCV) tests: For patients with active HBV: HBV DNA \\\u003C500 IU\u002Fml during screening, initiation of anti-HBV treatment at least 14 days prior to randomization and willingness to continue anti-HBV treatment during the study (per local standard of care; e.g., entecavir). For patients with HCV, either with resolved infection (as evidenced by detectable antibody) or chronic infection (as evidence by detectable HCV RNA), are eligible.\n16. Performance of an esophagogastroduodenoscopy within 6 months of inclusion and assessment and treatment of varices of all sizes per local standard of care prior to randomisation.\n17. Biliary tract obstruction has been relieved.\n18. Adequate biliary drainage, with no evidence of ongoing infection.\n19. Women of childbearing potential (WOCBP) having sex with an unsterilized male partner and unsterilized males having sex with a female partner of childbearing potential, must agree to use an effective method of contraception for the duration of trial participation and as required after completing study treatment. Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.\n20. WOCBP must have a negative serum pregnancy test performed within 3 days before randomisation and a negative urine pregnancy test on the day of first dose, prior to treatment administration.\n21. Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, and other study procedures.\n22. Affiliated to a social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\n\nExclusion Criteria:\n\n1. Toxicities from 1L-SoC not resolved to Grade ≤ 1 (according to version 5.0 of the National Cancer Institute - Common terminology criteria for adverse events \\[NCI-CTCAE v5.0\\]) before randomisation with the exception of alopecia.\n2. Received first-line maintenance therapy with a matched target therapy proposed in SAFIR ABC10, or any second-line treatment.\n3. Contraindication to ivonescimab.\n4. Proven complete deficiency of dihydropyrimidine dehydrogenase (DPD).\n5. Treatment with brivudine, sorivudine or their chemical analogues in the 4 weeks prior to randomisation.\n6. Major surgical procedures or serious trauma within 4 weeks prior to randomisation, or plans for major surgery within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterisation and port implantation) within 3 days prior to randomisation.\n7. History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to randomisation, including but not limited to:\n\n   1. Gastrointestinal bleeding.\n   2. Haemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots).\n\n      Note: transient haemoptysis associated with diagnostic bronchoscopy is allowed.\n   3. Nasal bleeding \u002Fepistaxis (bloody nasal discharge is allowed).\n   4. Need for therapeutic anticoagulant therapy within 14 days prior to randomization.\n\n   Note: Prophylactic anticoagulation for deep vein thrombosis or pulmonary embolism or to maintain venous patency is allowed.\n8. Current hypertension with systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n9. History of major diseases before randomization, specifically:\n\n   1. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association classification ≥ grade 2) or vascular disease (eg, aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia),\n   2. History of oesophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before randomisation,\n   3. History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in NCI-CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to randomization,\n   4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before randomisation,\n   5. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomisation.\n10. Imaging during the screening period shows that the patient has:\n\n    1. Radiologically documented evidence of major blood vessel invasion or encasement by cancer,\n    2. Radiographic evidence of intra-tumour cavitation.\n11. Microsatellite instability positive disease.\n12. Concurrent malignancy (other than advanced biliary tract cancer), with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 5 years or more and are deemed at negligible risk for recurrence, are eligible for the trial.\n13. HIV positive (HIV 1\u002F2 antibodies patients), or a known history of active Tuberculosis bacillus.\n14. Any immunosuppressive therapy (i.e. corticosteroids \\>10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy.\n15. Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n    1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study,\n    2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study,\n    3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n       * Rash must cover \\\u003C 10% of body surface area,\n       * Disease is well controlled at baseline and requires only low-potency topical corticosteroids,\n       * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months.\n16. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n17. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.\n18. Pregnant or breast-feeding females.\n19. Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable.\n20. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.\n21. Individuals deprived of liberty or placed under protective custody or guardianship.",{"count":509,"type":22},72,[119],"The object of this trial is to test whether ivonescimab is superior to standard chemotherapy (FOLFOX regimen) for the treatment of patients with advanced biliary tract cancer after failure of a first line of chemotherapy. It is only open to patients who participated in the SAFIR-ABC10 trial (NCT05615818) but did not receive experimental treatment.\n\nEligible patients will be randomised (2:1) to receive either ivonescimab or FOLFOX. Treatment will be continued until disease progression, or a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.",[28],[344,514,446],"Gallbladder","2026-05-18",{"date":517,"type":44},"2026-05-19",{"date":519,"type":44},"2025-10-09",{"date":521,"type":22},"2029-01-30",{"name":523,"class":358},"UNICANCER",41,{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":533,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":539,"overallStatus":423,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":4},"100640897","phase-2-gemcitabine-cisplatin-plus-envafolimab-in-resectable-biliary-tract-malignancies-100640897","NCT07599995","Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies","The Efficacy and Safety of Gemcitabine-Cisplatin Plus Envafolimab as Neoadjuvant Therapy in Resectable Biliary Tract Malignancies at High Risk of Recurrence","GENE","Inclusion Criteria:\n\n* Participants who have signed a written Informed Consent Form (ICF);\n* Male or female participants aged 18-80 years;\n* Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0\u002F1;\n* Biliary Tract Cancer (BTC) diagnosed by puncture pathology prior to enrollment;\n* Participants must meet the following requirements for major vital organ function: a. Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; platelet count ≥ 90×10⁹\u002FL; hemoglobin ≥ 9 g\u002FdL; b. Coagulation function: international normalized ratio (INR) ≤ 1.2; c. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 times the upper limit of normal (ULN); d. Serum albumin ≥ 3.5 g\u002FdL; total bilirubin ≤ 1.5 times the ULN. Patients with obstructive jaundice who meet the eligibility criteria after percutaneous transhepatic cholangial drainage or endoscopic retrograde cholangiopancreatography treatment are also eligible for enrollment; e. Child-Pugh class A or B; f. Serum creatinine ≤ 1.5 times the ULN;\n* Patients with high-risk factors for recurrence. The criteria are defined as meeting at least one of the following: a. Preoperative CA19-9 ≥ 200 U\u002FmL; b. Tumor diameter ≥ 5 cm or multiple tumor nodules on imaging; c. Regional lymph node metastasis with a short-axis diameter ≥ 1.0 cm on imaging; d. Vascular invasion (portal vein or hepatic artery) on imaging; e. Low or undifferentiated histologic grade;\n* Participants who have at least 1 measurable lesion (RECIST v1.1);\n* Be able to provide fresh stool samples and liver samples if undergoing surgery.\n\nExclusion Criteria\n\n* Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, and other non-cholangiocarcinoma malignant tumor components;\n* Prior systemic therapy for BTC, including immunotherapy, targeted therapy, or chemotherapy;\n* History of other prior or concurrent malignancies, except those with complete treatment and disease-free survival for more than 5 years;\n* Presence of an active, known or suspected autoimmune disease, or requirement for long-term systemic corticosteroid therapy (equivalent to ≥ 10 mg prednisone daily) or other immunosuppressive agents. Participants using inhaled or topical corticosteroids will not be excluded;\n* Presence of ascites, hepatic encephalopathy, sclerosing cholangitis, or other concurrent organ dysfunctions that would preclude tolerance of general anesthesia or hepatectomy;\n* Women who are breastfeeding or pregnant;\n* Any other factors that, in the investigator's judgment, may compromise participant safety or trial compliance, including serious comorbidities requiring ongoing treatment, clinically significant laboratory abnormalities, or relevant social or family-related issues.","80 Years",{"count":535,"type":22},34,[119],"This trial is to evaluate the efficacy of Gemcitabine-Cisplatin (GC) plus Envafolimab neoadjuvant therapy in the patients at high risk of recurrence. Primary endpoint: Major Pathologic Response (MPR). It will also learn about the safety of drug including Gemcitabine-Cisplatin (GC) plus Envafolimab as a neoadjuvant therapy in this trial.",[28],[540,541],"Resectable Biliary Tract Cancer","High Risk of Recurrence","2026-05-17",{"date":491,"type":44},{"date":545,"type":22},"2026-05-30",{"date":547,"type":22},"2030-03-30",{"name":549,"class":358},"Sir Run Run Shaw Hospital",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":578},"100534466","phase-1-dose-escalation-and-dose-expansion-study-of-mdx2001-in-patients-with-advanced-solid-tumors-100534466","NCT06239194","Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors","A Phase 1\u002F2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age\n* Histologically or cytologically confirmed diagnosis of metastatic solid tumors\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.\n* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Adequate hematologic, hepatic and renal function\n* Capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Any clinically significant cardiac disease\n* Unresolved toxicities from previous anticancer therapy\n* Prior solid organ or hematologic transplant\n* Known untreated, active, or uncontrolled brain metastases\n* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectiion requiring intravenous treatment.\n* Receipt of a live-virus vaccination within 28 days of planned treatment start\n* Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.\n* Participation in a concurrent clinical study in the treatment period.\n* Known hypersensitivity to MDX2001 or any of its ingredients\n* Supplemental oxygen use for activities of daily living\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",{"count":558,"type":22},285,[64,119],"This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.",[28,68,251,562,69,157,122,563,158,564,155,416,565,566,567,568],"Colon Cancer","GastroEsophageal Cancer","Hepatocellular Cancer","Prostate Cancer","Rectal Cancer","Renal Cancer","Thyroid Cancer","2026-05-03",{"date":571,"type":44},"2026-05-06",{"date":573,"type":44},"2024-06-12",{"date":575,"type":22},"2029-02",{"name":577,"class":51},"ModeX Therapeutics, An OPKO Health Company",6,{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":238},"100636745","phase-2-alternating-haic-and-systemic-chemotherapy-with-or-without-adebrelimab-and-apatinib-for-unresectable-biliary-tract-cancer-100636745","NCT07569679","Alternating HAIC and Systemic Chemotherapy With or Without Adebrelimab and Apatinib for Unresectable Biliary Tract Cancer","A Prospective, Real-World Study of Alternating Hepatic Arterial Infusion Chemotherapy and Systemic Chemotherapy With or Without Adebrelimab and Apatinib in Patients With Unresectable Biliary Tract Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of enrollment.\n2. Histologically or cytologically confirmed diagnosis unresectable, locally advanced, or metastatic BTC, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.\n3. No prior systemic therapy for BTC, including chemotherapy, immunotherapy, or small-molecule targeted therapy.\n4. Patients with disease recurrence ≥6 months after curative resection and completion of adjuvant therapy (chemotherapy or radiotherapy) are eligible.\n5. Adequate liver function: defined as Child-Pugh Class A (score 5-6) or well-compensated Class B (score ≤7).\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. At least one measurable lesion as defined by RECIST 1.1.\n8. Assessed by the investigator as being able to tolerate and comply with the study treatment regimen.\n9. Provision of written informed consent, voluntarily agreeing to participate after full explanation of the study protocol.\n\nExclusion Criteria:\n\n1. Hepatic tumor burden occupying ≥50% of total liver volume.\n2. History of liver transplantation.\n3. Major surgery or invasive procedure (excluding intravenous catheter placement or percutaneous drainage) within 4 weeks prior to enrollment.\n4. History or evidence of clinically significant bleeding, including: bleeding \\>30 mL within 3 months prior to enrollment (including hematemesis, melena, or hematochezia), hemoptysis (\\>5 mL of fresh blood) within 4 weeks prior to enrollment, or thromboembolic events (including stroke or transient ischemic attack) within the past 12 months.\n5. Known active infection with human immunodeficiency virus (HIV).\n6. Pregnant (a positive pregnancy test prior to study drug administration) or breastfeeding women.\n7. Any condition, in the investigator's judgment, that could compromise patient satety, affect the assessment of study outcomes, or lead to premature discontinuation. this includes, but is not limited to: active alcohol or substance abuse, severe uncontrolled comorbidities, significant laboratory abnormalities, or social\u002Ffamily circumstances that could interfere with protocol compliance.",{"count":587,"type":22},124,[119],"This prospective real-world study aims to evaluate the effectiveness and safety of an alternating treatment regimen combining hepatic arterial infusion chemotherapy (HAIC) with systemic chemotherapy, with or without adebrelimab and apatinib, in patients with unresectable biliary tract cancer receiving first-line treatment. The study comprises two cohorts: one receiving alternating HAIC and systemic chemotherapy alongside adebrelimab and apatinib, and the other receiving alternating HAIC and systemic chemotherapy alone. Treatment allocation follows real-world clinical decision-making. Patients will be monitored throughout the treatment period to assess tumor response, survival outcomes, and safety profiles. The study aims to generate evidence on the clinical benefits of integrating immunotherapy and targeted therapy into HAIC-based regimens for this patient population.",[28],[28,592,593,594,595],"First-Line Treatment","HAIC","Adebrelimab","Apatinib","2026-04-29",{"date":571,"type":44},{"date":599,"type":44},"2025-12-10",{"date":601,"type":22},"2028-12-30",{"name":603,"class":358},"Air Force Military Medical University, China",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":205,"enrollmentInfo":611,"targetDuration":4,"studyType":23,"phases":613,"briefSummary":614,"conditions":615,"keywords":616,"overallStatus":423,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":4},"100636137","phase-2-adebrelimab-plus-s-1-for-resected-cholangiocarcinoma-100636137","NCT07561775","Adebrelimab Plus S-1 for Resected Cholangiocarcinoma","A Single-Arm, Exploratory Clinical Study of Adebrelimab Combined With S-1 in Patients With Resected Cholangiocarcinoma","Inclusion Criteria:\n\n* Histologically or pathologically confirmed malignant cholangiocarcinoma.\n* Patients who have undergone curative surgical resection.\n* Age between 18 and 75 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Expected survival time \\>3 months.\n* Adequate organ and bone marrow function, including:Absolute neutrophil count ≥1.5 × 10\\^9\u002FL,Platelet count ≥75 × 10\\^9\u002FL,Hemoglobin ≥90 g\u002FL,Total bilirubin ≤1.5 × upper limit of normal (ULN),AST and ALT ≤2.5 × ULN,Albumin ≥3 g\u002FdL,Serum creatinine ≤1.5 × ULN.\n* Ability to understand and willingness to sign written informed consent.\n* For patients of childbearing potential, willingness to use effective contraception during the study and for at least 1 month after the last dose; negative pregnancy test within 72 hours prior to enrollment.\n\nExclusion Criteria:\n\n* Prior treatment with immune checkpoint inhibitors or other agents targeting T-cell co-stimulatory or co-inhibitory pathways (e.g., CTLA-4, CD137).\n* Use of any investigational drug within 4 weeks prior to enrollment.\n* Active autoimmune disease or history of autoimmune disease (e.g., interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, or hypothyroidism requiring hormone replacement).\n* Known immunodeficiency, including HIV infection, active hepatitis B (HBV DNA \\>500 IU\u002FmL), active hepatitis C (HCV RNA above detection limit), or co-infection of HBV and HCV.\n* Severe infection within 4 weeks prior to first dose or unexplained fever \\>38.5°C during screening.\n* History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Uncontrolled psychiatric disorders.\n* Severe or uncontrolled comorbidities that may interfere with study participation (e.g., unstable angina, myocardial infarction within 6 months, symptomatic arrhythmia, congestive heart failure, uncontrolled diabetes, or uncontrolled infection).\n* History of other malignancies within the past 5 years, except for non-melanoma skin cancer or carcinoma in situ.\n* Known hypersensitivity to study drugs or monoclonal antibodies.\n* Inability or unwillingness to provide informed consent.",{"count":612,"type":22},40,[119],"The goal of this clinical trial is to learn whether adebrelimab combined with S-1 works as an adjuvant treatment for patients with cholangiocarcinoma after curative surgery. It will also learn about the safety of this treatment. The main questions it aims to answer are:\n\n* Does adebrelimab combined with S-1 reduce the risk of cancer recurrence after surgery?\n* What side effects do participants experience when receiving this treatment? All participants in this study will receive adebrelimab combined with S-1. There is no comparison group in this study.\n\nParticipants will:\n\n* Receive adebrelimab by intravenous infusion once every 3 weeks for 4 cycles\n* Take S-1 by mouth twice daily for 4 weeks, followed by a 2-week rest, for 4 cycles\n* Visit the hospital regularly for checkups, laboratory tests, and imaging examinations (CT or MRI)\n* Be followed up for safety and survival after completing treatment",[446,28],[594,617,618,619,620,621],"S-1","Adjuvant Therapy","Postoperative Treatment","PD-L1 Inhibitor","Immunotherapy","2026-04-25",{"date":624,"type":44},"2026-05-01",{"date":626,"type":22},"2026-04-21",{"date":628,"type":22},"2032-01-01",{"name":630,"class":358},"Xingjun Guo",{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":477,"enrollmentInfo":638,"targetDuration":4,"studyType":23,"phases":639,"briefSummary":640,"conditions":641,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":238},"100570547","phase-1-hx009-in10018-with-or-without-standard-chemotherapy-for-advanced-solid-tumours-100570547","NCT06708663","HX009+ IN10018 With or Without Standard Chemotherapy for Advanced Solid Tumours","Phase IIa Study of HX009+IN10018 in Patients With Advanced Solid Tumours, Including Biliary Tract Malignancies and Malignant Melanoma, Treated With or Without Standard Chemotherapy","Inclusion Criteria:\n\n1. Voluntarily participate in the trial and sign the informed consent form;\n2. male or female, age at 18 to 70 years (including borderline value) ;\n3. expected survival ≥ 12 weeks;\n4. ECOG score 0-1;\n5. patients with unresectable\u002Fmetastatic advanced solid tumours (including biliary tract malignancies and malignant melanoma) confirmed by cytology or histopathology; Part I: Failed standard therapy, or no effective standard therapy (prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies may be eligible for enrolment); Part II: No prior systemic therapy (prior neoadjuvant and adjuvant therapy is permitted, but needs to have been completed at least 6 months ago);\n\nExclusion Criteria:\n\n1. Histological or pathological diagnosis of carcinoma of the jugular abdomen;\n2. Patients with melanoma with known BRAF v600E mutation and NRAS mutation; patients with cholangiocarcinoma and gallbladder cancer with known BRAF v600E mutation, NTRK gene fusion, RET gene fusion mutation, FGFR2 gene fusion, IDH1 gene mutation, and KRAS mutation\n3. Subjects with symptomatic brain metastases, meningeal metastases, or spinal cord compression, except for the following: asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain metastases, no need for corticosteroid or antiepileptic drugs, and the lesion has been stable for ≥4 weeks as confirmed by imaging tests);\n4. have had a malignancy other than the study disease (biliary malignancy, malignant melanoma) within 5 years prior to signing the ICF, except for malignancies with negligible risk of metastasis or death and\u002For those that have received curative treatment (e.g. adequately treated cervical carcinoma in situ, basal or squamous cell skin carcinoma, confined prostate cancer, ductal carcinoma in situ, or stage I uterine cancer);\n5. Subjects with an active, or history of, autoimmune disease that is likely to recur or is currently being treated (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or at high risk (e.g., organ transplants requiring immunosuppressive therapy). However, subjects with the following diseases were allowed to enrol:\n\n   * Type 1 diabetes mellitus that has stabilised with the use of fixed doses of insulin;\n   * Autoimmune hypothyroidism and adrenal insufficiency requiring only hormone replacement therapy;\n   * Skin diseases that do not require systemic therapy: e.g. eczema, rashes that cover less than 10 per cent of the body surface, psoriasis without ocular symptoms.\n6. have severe cardiovascular disease such as symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina, uncontrolled hypertension (systolic blood pressure ≥160 and\u002For diastolic blood pressure ≥100 mmHg under pharmacological control), cardiac arrhythmia, history of myocardial infarction within 6 months, or history of arterial thromboembolism or pulmonary embolism within 3 months prior to the first administration of the drug\n7. suffering from a serious lung disease requiring treatment or previous serious lung disease, interstitial lung disease, interstitial pneumonitis, pulmonary fibrosis, radiation pneumonitis requiring hormonal therapy, etc;\n8. uncontrolled concomitant medical conditions including, but not limited to, severe diabetes mellitus (fasting blood glucose \\> 250 mg\u002Fdl or 13.9 mmol\u002FL), active infectious diseases, psychiatric disorders (e.g., epilepsy) that may interfere with adherence, or other serious conditions requiring systemic therapy\n9. patient with uncontrolled pleural effusions, abdominal effusions or pericardial effusions that require repeated drainage. Individuals with indwelling drains are permitted to be enrolled;",{"count":587,"type":22},[64,119],"Phase IIa study of HX009+ IN10018 in combination with or without standard chemotherapy in patients with advanced solid tumours including biliary tract malignancies and malignant melanoma",[28,642],"Melanoma","2026-04-15",{"date":645,"type":44},"2026-04-16",{"date":647,"type":44},"2025-01-17",{"date":649,"type":22},"2028-12-31",{"name":651,"class":51},"Hangzhou Hanx Biopharmaceuticals, Ltd.",{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":4,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":205,"enrollmentInfo":659,"targetDuration":4,"studyType":23,"phases":661,"briefSummary":662,"conditions":663,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":665,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":670,"locationsCount":672},"100549244","phase-1-a-study-of-tqb2102-for-injection-in-the-treatment-of-her2-positive-biliary-tract-cancer-100549244","NCT06431490","A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer","A Study to Evaluate the Efficacy, Safety, and Immunogenicity of TQB2102 for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer","Inclusion Criteria:\n\n* 18 years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1;\n* Subjects must provide sufficient tumor tissue sample and confirm HER2 positivity by central laboratory prior to first dose, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with in situ hybridization (ISH) positive;\n* The main organs function well;\n* Meet the criteria for advanced biliary tract cancer:\n\n  1. Biliary tract carcinoma confirmed by histology or cytology;\n  2. Non-operable locally advanced, recurrent and\u002For metastatic disease with at least one measurable lesion according to Evaluation criteria for the efficacy of solid tumors (RECIST) 1.1 criteria;\n  3. Failure of 1-2 prior lines of systemic therapy\n* Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period;\n* The subjects voluntarily joined the study, signed the informed consent, and the compliance was good.\n\nExclusion Criteria:\n\n* Complicated diseases and medical history:\n\n  1. Have had or are currently suffering from other malignant tumors within 3 years before the first medication;\n  2. Unmitigated toxic effects higher than grade 1 of Common Terminology Criteria for Adverse Events (CTCAE) due to any previous treatment;\n  3. Major surgical treatment, significant traumatic injury, or long-term unhealed wounds or fractures have been received within 4 weeks prior to initial medication;\n  4. Patients with any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first dose; Aortic\u002Fvenous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to initial administration; Treatment with low molecular weight heparin was permitted and antiplatelet drugs were prohibited throughout the study period;\n  5. Active viral hepatitis with poor control;\n  6. There is a history of active tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment or active pneumonia with clinical symptoms;\n  7. Have a history of psychotropic drug abuse and can not quit or have mental disorders;\n  8. People who are ready to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation;\n  9. Have a history of hepatic encephalopathy;\n  10. Currently on or recently used (within 7 days before the start of study treatment) aspirin (\\>325 mg\u002F day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol;\n  11. Subjects with any severe and\u002For uncontrolled disease.\n* Tumor related and treatment:\n\n  1. For subjects who have received chemotherapy, immunotherapy within 3 weeks before the first dose, radiation therapy or small molecule targeted drugs within 2 weeks, or who are still within the 5 half-lives of the drug (as the shortest time of occurrence), the washout period is calculated from the end time of the last treatment;\n  2. Within 2 weeks before the first use of the drug, the treatment of Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;\n  3. Imaging including computed tomography (CT) or magnetic resonance imaging (MRI) shows that the tumor has invaded important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels during the follow-up study period and cause fatal massive bleeding;\n  4. Uncontrolled pleural effusion, pericardial effusion or moderate to severe ascites that still require repeated drainage;\n  5. Obvious biliary obstruction (except for total bilirubin ≤ 2× upper limit of normal (ULN) after endoscopic stent placement and percutaneous transhepatic biliary drainage);\n  6. Known spinal cord compression, cancerous meningitis, with symptoms of brain metastases, or symptoms controlled for less than 4 weeks.\n* Research treatment related:\n\n  1. Known allergy to study drug excipients;\n  2. Have previously received anti-HER2 therapy drugs (only for the second stage, the first stage is not limited);\n  3. Patients who require immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and who continue to use it for 7 days prior to initial administration (except for corticosteroids \\\u003C10 mg per day of prednisone or other therapeutic hormones).\n  4. Participants who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication.\n  5. According to the judgment of the researcher, there is a situation that seriously endangers the safety of the subjects or affects the completion of the study.",{"count":660,"type":22},102,[64,119],"To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.",[28],"2026-04-02",{"date":666,"type":44},"2026-04-08",{"date":668,"type":44},"2024-07-22",{"date":355,"type":22},{"name":671,"class":51},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",43,{"id":674,"slug":675,"hasResults":12,"nctId":676,"briefTitle":677,"officialTitle":678,"acronym":4,"eligibilityCriteria":679,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":680,"targetDuration":4,"studyType":23,"phases":682,"briefSummary":683,"conditions":684,"keywords":686,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":698},"100495622","phase-2-study-of-rp2-in-combination-with-second-line-therapy-in-patients-with-locally-advanced-or-metastatic-hcc-100495622","NCT05733598","Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC","A Phase 2, Open-label, Multicenter Study Investigating RP2 Oncolytic Immunotherapy in Combination With Second-line Therapy in Patients With Locally Advanced Unresectable, Recurrent and\u002For Metastatic Hepatocellular Carcinoma","Key Inclusion Criteria:\n\nI 1. Male or female ≥ 18 years of age. I 2. (HCC only) Has locally advanced unresectable, recurrent, and\u002For metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features or imaging criteria (using LI-RADS v2018; \\[Chernyak 2018\\]) according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis (Marrero 2018). Sites should select lesions that are either \"probable HCC - LIRADS 4\" or \"definite HCC - LIRADS 5\".\n\nI 3. (HCC only) Must have progressed while on first and only systemic therapy, which must have included anti PD-1 or anti-PD-L1 therapy (eg, atezolizumab plus bevacizumab combination, durvalumab plus tremelimumab combination, durvalumab, pembrolizumab, or nivolumab monotherapy or nivolumab in combination with ipilimumab) as their immediate prior treatment regimen.\n\nI 4. (HCC only) Child-Pugh A, determined within 14 days before first study treatment.\n\nI 5. Has at least 1 measurable tumor of ≥ 1 cm in longest diameter (or ≥ 1.5 cm shortest diameter for lymph nodes) as defined by RECIST 1.1.\n\nI 6. Has injectable tumor(s), which alone or in aggregate, total at least 1 cm in diameter.\n\nI 7. Must be willing to consent to provide fresh tumor biopsy sample or archival tumor biopsy sample obtained within 90 days before the first dose of study treatment.\n\nI 8. Has adequate hematologic function, including: White blood cell (WBC) count ≥ 2.0 × 109\u002FL; absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL (without granulocyte-colony stimulating factor support); platelet count ≥ 75 × 109\u002FL (without transfusion); hemoglobin ≥ 8.5 g\u002FdL (may have received transfusions; however, patient must not be transfusion-dependent).\n\nI 9. Has adequate hepatic function including: total bilirubin ≤ 3.0 × upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 5.0 × ULN.\n\nI 10. Has adequate renal function, defined as serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 30 mL\u002Fminute (measured using Cockcroft-Gault formula).\n\nI 11. Serum albumin ≥ 2.8 g\u002FdL. I 12. Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio \\[INR\\] ≤ 1.7) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n\nI 13. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n\nI 14. Female and male patients who meet the following criteria:\n\n1. Female patients are eligible if not pregnant (see IC #15) or breastfeeding and if one of the following applies 1) is a woman of non-childbearing potential (WNCBP) OR 2) is a woman of childbearing potential and must agree to use a highly effective contraception method during the treatment period, and for at least (a) 90 days after the last dose of RP2 or (b) 5 months after the last dose of atezolizumab, or (c) 6 months after the last dose of bevacizumab, or (d) 90 days after the last dose of durvalumab, whichever is longer.\n2. Male patients are eligible to participate if they agree to the following during the study treatment period, and for at least 90 days after the last dose of RP2: refrain from donating fresh unwashed sperm plus either be abstinent from intercourse where pregnancy can occur (abstinent on a long term and persistent basis) OR must agree to use an external condom and also should advise their partner to use a highly effective method of contraception as a condom may break or leak.\n\nI 15. Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test with a minimum sensitivity of 25 IU\u002FL or equivalent units of β hCG within 72 hours before the first dose and a negative urine pregnancy test on Dose 1 Day 1.\n\nI 16. Capable of giving signed informed consent which includes willingness to comply with the requirements and restrictions listed in the informed consent form and in this protocol.\n\nI 17. (BTC only) Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma whose disease has not progressed following the concurrent treatment with gemcitabine, platinum containing chemotherapy, and checkpoint inhibitors.\n\nPatients must be on combination treatment with gemcitabine, platinum containing chemotherapy, and a checkpoint inhibitor for a minimum of 12 weeksand maximum of 24 weeks. After the last combination chemotherapy treatment (gemcitabine plus platinum chemotherapy), checkpoint inhibitor treatment must be limited to 2 doses (8 weeks).\n\nNote: Patients who develop toxicity and discontinue platinum containing chemotherapy per treating physicians may enroll into the trial as long as they receive gemcitabine and durvalumab for 12 weeks. SD or PR must be documented on at least 2 scans while on prior combination treatment; the second scan can be the same as the baseline scan.\n\nKey Exclusion Criteria:\n\nE 1. (HCC only) Child-Pugh B or C. E 2. (HCC only) Patients with untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or high-risk for bleeding.\n\nNote: Note: All patients in Cohort 1a and 1b must undergo an esophagogastroduodenoscopy (EGD), and all varices (irrespective of size) must be assessed and treated regardless of grade before enrollment. Patients who have undergone endoscopic treatment of all known varices 90 days before initiation of study treatment do not need to repeat the procedure.\n\nNote: EGD is not required for patients in Cohort 2 (RP2 monotherapy). E 3. Significant bleeding event within the last 12 months that places the patient at unjustifiable risk for bleeding from intratumoral injection procedures, based on Investigator or interventional radiologist assessment.\n\nE 4. (HCC only) Macroscopic intravascular invasion into the hepatic and\u002For portal vein(s) (ie, no Vp4), , vena cava, and\u002For other major blood vessel, or into the common bile duct(s).\n\nE 5. (HCC only) Histologic evidence of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma with HCC, or other rare HCC variants.\n\nE 6. History of medically refractory hepatic encephalopathy and\u002For hepato-renal syndrome.\n\nE 7. Disease that is amenable to curative surgical and\u002For locoregional therapies.\n\nE 8. Presence of liver tumors that are estimated to invade more than one-third of the liver.\n\nE 9. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage within 7 days before enrollment.\n\nE 10. Hepatitis B virus (HBV) DNA \\> 500 IU\u002FmL obtained within 28 days prior to initiation of study treatment. Co-infection of HBV and hepatitis C virus (HCV) is not allowed.\n\nNote: Patients with HBV DNA ≤ 500 U\u002FmL are eligible to enroll in the study. Patients must be on anti-HBV treatment (per local standard care that do not have activity with HSV. Entecavir, tenofovir, telbivudine, lamivudine can be used. Anti-HBV treatment must be given for a minimum of 14 days prior to Week 1 Day 1 and must continue antiviral treatment for the length of the study.\n\nE 11. Known human immunodeficiency virus (HIV) infection. Note: Testing for HIV is not required unless mandated by local health authority or clinically indicated.\n\nE 12. Active significant herpetic infections or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis) or requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).\n\nNote: Patients with sporadic cold sores may be enrolled if no active cold sores are present at the time of Dose 1 Day 1.\n\nE 13. Systemic infection requiring IV antibiotics or other serious infection within 14 days before dosing.\n\nE 14. Received a live vaccine within 28 days before the first dose of study treatment.\n\nE 15. Known central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n\nE 16. Prior malignancy, other than HCC and BTC, active within the previous 3 years, except for localized cancers that have apparently been cured or only required surveillance (eg. basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).\n\nE 17. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment.\n\nNote: Patients who have entered the follow-up phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent.\n\nE 18. Systemic anticancer therapies within 4 weeks of the first dose of study drug.\n\nNote: Patients must have recovered (to Grade ≤ 1 or baseline) from all AEs due to previous therapies. Patients with Grade ≤ 2 neuropathy may be eligible if approved by the Medical Monitor.\n\nE 19. Received radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities (except for radiation-induced xerostomia), not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.\n\nE 20. Received prior treatment with an oncolytic virus therapy. E 21. History of significant cardiac disease including myocarditis or congestive heart failure (defined as New York Heart Association Functional Classification III or IV), or unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months of enrollment.\n\nE 22. Uncontrolled infection requiring intravenous antibiotics. E 23. History of interstitial lung disease, idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), non-infectious pneumonitis that required steroids, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n\nNote: History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n\nE 24. Active tuberculosis. E 25. History or evidence of psychiatric, substance abuse, or any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the Investigator or the Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.\n\nE 26. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.\n\nE 27. Active, known, or suspected autoimmune disease requiring systemic treatment.\n\nNote: Patients with type 1 diabetes mellitus and\u002For hypothyroidism requiring only hormone replacement, and\u002For with autoimmune skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, and\u002For prior non-serious autoimmune conditions not expected to recur are permitted to enroll.\n\nE 28. Conditions requiring treatment with immunosuppressive doses (\\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids within 14 days before Dose 1 Day 1.\n\nNote: Patients who require a brief course (≤ 7 days) of corticosteroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded. Physiologic replacement doses of systemic corticosteroids are permitted, only if the dose does not exceed 10 mg\u002Fday prednisone equivalent.\n\nE 29. Sensitivity to any of the study interventions, or components or thereof, or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n\nE 30. History of life-threatening toxicity related to prior immune therapy (eg, anti-cytotoxic T lymphocyte antigen 4 or anti-PD-1\u002Fanti-PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways \\[eg, CD40, 4 1BB\\]) except those that are unlikely to recur or are expected to be manageable with standard countermeasures (eg, hormone replacement after adrenal crisis). Individual cases should be discussed with Medical Monitor if needed.\n\nE 31. (HCC only) Current or recent (within 10 days of first dose of study treatment) use of aspirin or treatment with dipyridamole, ticlopidine, clopidogrel, or cilostazol. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purpose.\n\nNote: Prophylactic anticoagulation for the patency of venous access devices is allowed.\n\nE 32. Treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks before treatment.\n\nE 33. Prior organ transplantation including allogeneic stem-cell transplantation.\n\nE 34. (HCC only) Major surgery within 28 days before starting bevacizumab or anticipated major surgery while on study.\n\nNote: If a patient received major surgery, they must have recovered adequately from the intervention before starting study treatment and must have adequate wound healing, based on Investigator's assessment or surgeon's assessment, before starting bevacizumab.\n\nE 35. (BTC only) Ampullary carcinoma or mixed cholangiocarcinoma with HCC. E 36. (BTC only) Patients with mismatch repair deficiency and microsatellite instability-high are excluded.",{"count":681,"type":22},60,[119],"The purpose of this study is to assess the efficacy and safety of RP2 in combination with atezolizumab plus bevacizumab (Cohorts 1a and 1b) and RP2 monotherapy (Cohort 2) in the as second line treatment in patients with locally advanced unresectable, recurrent, and\u002For metastatic HCC and in combination with durvalumab as treatment in patients with unresectable locally advanced or metastatic BTC.",[685,28],"Hepatocellular Carcinoma",[687,685,688,28,689],"Oncolytic virus","HCC","BTC","2026-03-31",{"date":664,"type":44},{"date":693,"type":44},"2024-08-01",{"date":695,"type":22},"2028-07-01",{"name":697,"class":51},"Replimune, Inc.",12]