[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"triple-negative-breast-cancer-tnbc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:triple-negative-breast-cancer-tnbc":695},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,63,0,25,[9,50,84,107,137,168,195,222,257,282,310,340,367,401,421,443,472,495,520,539,576,595,621,648,669],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100651544","phase-1-combination-immunotherapy-treatment-for-locally-advanced-unresectable-or-metastatic-pd-l1-negative-cps10-gbrca-negative-triple-negative-breast-cancer-including-breakvax-immunotreatment-designed-and-manufactured-per-patient-chemotherapy-and-anti-pd-1-therapy-100651544",false,"NCT07762703","Combination Immunotherapy Treatment for Locally Advanced Unresectable or Metastatic, PD-L1 Negative (CPS\u003C10), gBRCA Negative, Triple Negative Breast Cancer Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy","Phase 1\u002F2 Trial of a Combination Immunotherapy Treatment for Solid Tumors Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy","Inclusion Criteria:\n\n1. Age ≥ 18 years and \\\u003C 72\n2. Patients with histologically confirmed locally advanced unresectable or metastatic, PD-L1 negative (CPS \\\u003C10), gBRCA-negative TNBC who received first-line ADC treatment and experienced disease progression and have sent 200mg (approximately) of tumor tissue (fresh tissue immersed in AllProtect then frozen) to BreakBio for analysis.\n3. Must have measurable disease per RECIST v1.1 (at least one non-nodal lesion ≥10 mm in longest diameter and\u002For pathologic lymph node(s) ≥15 mm in short axis on CT\u002FMRI) on imaging obtained within 21 days of first dose of treatment combination.\n4. Must not have experienced progression during the induction chemotherapy cycles.\n5. Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1 on day of first dose\n6. Patient has adequate organ function on day one of the trial as defined by:\n\n   * Neutrophil to Lymphocyte Ratio (NLR)1 at a healthy adult's normal level: ≤ 3.5\n   * Absolute Neutrophil Count (ANC) at the normal level: ≤ 7,000\u002Fmm3\n   * Absolute Lymphocyte Count in normal level: ≥ 1,000\u002Fmm3\n   * Monocytes at normal level: \\\u003C 700\u002Fmm3\n   * Platelet count: ≥ 100 x 109\u002FL (without transfusion support in the last two weeks)\n   * Hemoglobin: \\> 10.0 g\u002FdL (without transfusion support in the last two weeks)\n   * AST and ALT: ≤ 3 X institutional upper limit of normal (ULN) in the absence of liver mets; AST and\u002For ALT may be ≤ 5 x ULN in the setting of liver metastases\n   * Total Bilirubin: ≤ 1.2mg\u002FdL\n   * Serum creatinine: ≤ 1.5 x institution's ULN\n   * Albumin: ≥ 3.4 g\u002FdL\n   * Serum Magnesium: ≥ 1.7 mg\u002FdL\n   * Pulse oximetry ≥ 95% on room air\n7. Provision of consent for on-treatment biopsy (compulsory) and post-treatment biopsy (optional).\n8. Both male and female patients enrolled in this trial must agree to use effective contraception during the course of the trial and for at least 3 months after discontinuing study treatment. Patients and\u002For partners who are surgically sterile or postmenopausal are exempt from this requirement.\n9. Negative pregnancy test ≤ 7 days prior to day one of cycle 1, for women of childbearing potential only.\n10. Life expectancy \\> 6 months\n11. Willing and able to provide informed consent\n\nExclusion Criteria:\n\n1. Prior exposure to anti PD- 1\u002FPD-L1 agents.\n2. Prior exposure to immunosuppressive therapy within the last 12 months prior to enrollment\n3. Receiving or previously receiving oral or IV steroids within 6 weeks of starting study treatment. Currently using or previously used topical steroids within 6 weeks of starting study treatment. Expected to require steroid-containing pre-meds before chemotherapy doses.\n4. Patients with deficient mismatch repair (dMMR) or microsatellite instability (MSI-H) phenotype.\n5. Any liver metastasis greater than 2 cm or greater than 5 liver metastases. Patients who have liver metastasis removed by surgery, and therefore meet this criterion at first dose, may enroll.\n6. Patients not recovered from all clinically significant toxic effects of previous therapies to ≤Grade 1 or baseline with the exception of peripheral neuropathy and alopecia.\n7. Patients not recovered adequately from the toxicity and\u002For complications from any major surgery prior to starting study treatment.\n8. Known or suspected hypersensitivity to any of the study drugs\n9. Received an investigational agent within 28 days prior to the first dose of study drug.\n10. History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction within the past 6 months. Note: Prior to trial entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.\n11. LVEF \\\u003C50%\n12. Active interstitial lung disease (ILD)\u002Fpneumonitis or a history of ILD\u002Fpneumonitis requiring treatment with systemic steroids.\n13. Untreated, symptomatic, or progressing brain\u002FCNS metastases; leptomeningeal disease; or prior whole-brain radiation. CNS metastases are allowed only if treated and stable on MRI for ≥8 weeks, the patient has recovered from CNS therapy, and has been off steroids for ≥12 weeks.\n14. Known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. (Individuals who are hepatitis C antibody positive may be enrolled if negative viral load confirmed).\n15. History of autoimmune disease including: inflammatory bowel disease (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g. Wegener's granulomatosis); central nervous system or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barré syndrome, myasthenia gravis, multiple sclerosis). Individuals with vitiligo, Sjogren's Syndrome, interstitial cystitis, Graves' or Hashimoto's Disease, celiac disease, DM1, hypothyroidism stable on hormone replacement, or any autoimmune disease without symptoms and not requiring active therapy for at least 2 years will be allowed with Study Medical Monitor's approval.\n16. A serious local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) which requires systemic antibiotic treatment within 4 weeks prior to the first dose of study medication.\n17. Receiving coumarin-derived anticoagulants.\n18. Unable or unwilling to withhold or discontinue any prohibited or restricted medications\u002F procedures for the specified windows during the study.\n19. Inability or refusal to comply with the protocol or with the clinical trial procedures\n20. If female, pregnant or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to starting treatment.\n21. Chronic intake of drugs that lead to known interference with metabolism through strong Cytochrome P450 3A4 (CYP3A4) interaction: e.g. Rifampicin, Rifabutin, Clarithromycin, Telithromycin, Ketoconazole, Itraconazole, Fluconazole, Hypericum perforatum (St. John's Wort \u002FJohanniskraut) or any strong CYP3A4 inducing or inhibiting drug (Note: participants in this study should avoid consuming grapefruit or grapefruit-containing products during the duration of the study, including the screening phase, treatment period, and follow-up period.)\n22. Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy.\n23. Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months before the start of study medication. Active pulmonary emboli or deep vein thrombosis that are significant or not adequately controlled on anticoagulation regimen\n24. Any hemorrhage or bleeding event ≥ National Cancer Institute - Common terminology criteria for adverse events (NCI-CTCAE) Grade 3 within 28 days prior to the start of study medication\n25. History of other invasive cancer within 2 years prior to enrollment, except for treated non-melanoma skin cancer\n26. Known DNA Polymerase Epsilon (POLE) mutations","ALL","18 Years","72 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The objective of this study is to evaluate the safety, feasibility, and preliminary antitumor activity of this multi-component immunotherapy strategy in patients with advanced solid tumors. The study is designed to assess whether coordinated enhancement of antigen-specific T-cell priming and tumor microenvironment modulation can improve immune-mediated tumor control.\n\nIn this study, BreakVax with adjuvants (Montanide and Poly-ICLC) is administered in combination with:\n\n1. Low-dose subcutaneous ipilimumab at the injection site as a dendritic cell adjuvant to enhance local dendritic cell-mediated T-cell priming;\n2. Pembrolizumab to mitigate PD-1-mediated T-cell exhaustion and sustain effector function;\n3. Standard-of-care chemotherapy, which may promote immunogenic cell death, increase antigen release and modulate the tumor microenvironment; and\n4. Losartan and aspirin, which have been associated in preclinical and translational studies with modulation of stromal architecture, vascular normalization, and reduction of tumor-associated immunosuppressive signaling.\n\nThe study consists of two components: a Safety Lead-in Cohort and a randomized combination therapy cohort. The Safety Lead-in Cohort is designed to evaluate safety and tolerability of the study combination and to characterize dose-limiting toxicities (DLTs). The randomized combination therapy cohort portion is designed to evaluate the antitumor activity of the study combination compared with standard-of-care (SOC) chemotherapy of physician's choice, as measured by objective response rate (ORR), and to evaluate disease control rate (DCR) in patients who receive the study combination following progression on SOC chemotherapy.",[29],"Triple-Negative Breast Cancer (TNBC)",[31,32,33,34,35,36],"Triple Negative Breast Cancer","PD-L1 negative","gBRCA negative","Locally Advanced","Unresectable","Metastatic","NOT_YET_RECRUITING","2026-08-18",{"date":40,"type":41},"2026-08-19","ACTUAL",{"date":43,"type":22},"2026-09",{"date":45,"type":22},"2030-09",{"name":47,"class":48},"BreakBio Corp","INDUSTRY",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":72,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100606945","phase-1-a-phase-1-study-of-nrm-823-in-participants-with-locally-advanced-or-metastatic-refractory-solid-tumors-100606945","NCT07182149","A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","A Phase 1a\u002F1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","Inclusion Criteria:\n\n* Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric\u002FGEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate liver, renal, pulmonary, and cardiac function.\n* Adequate hematologic function.\n\nExclusion Criteria:\n\n* Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823\n* History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy.\n* Has received an investigational therapy \\\u003C4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823.\n* With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.",{"count":58,"type":22},150,[25],"This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.",[62,63,64,65,66,67,68,69,70,71],"HNSCC","ESCC","Esophageal Adenocarcinoma","Gastric Adenocarcinoma","GEJ Adenocarcinoma","Ovarian Cancer","NSCLC","Cervical Cancer","Endometrial Cancer","Triple Negative Breast Cancer (TNBC)",[73],"NRM-823","RECRUITING","2026-08-17",{"date":38,"type":41},{"date":78,"type":41},"2025-10-30",{"date":80,"type":22},"2028-10-31",{"name":82,"class":48},"Normunity AccelCo, Inc.",18,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100634856","phase-1-a-phase-1a1b-first-time-in-human-study-of-ct-202-a-nectin-4-directed-bispecific-antibody-in-participants-with-recurring-triple-negative-breast-colorectal-urothelial-cancers-100634856","NCT07545122","A Phase 1a\u002F1b, First-Time-in-Human Study of CT-202, a Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, Urothelial Cancers","A Phase 1a\u002F1b, First Time in Human Study of CT-202, A Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, and Urothelial Cancers","CT-202","Inclusion Criteria:\n\n* Participants with nectin-4-positive triple negative breast cancer, colorectal cancer, or urothelial cancer that have received standard therapies\n* Participants with measurable disease per RECIST 1.1\n* ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks\n* Participants have adequate organ function.\n\nExclusion Criteria:\n\n* History of severe skin toxicity\n* Uncontrolled significant active infection or any medical or other condition that in the opinion of the Investigator would preclude the participant's participation in the study.\n* Concurrent participation in another investigational clinical trial.",{"count":93,"type":22},162,[25],"This is a Phase 1a\u002F1b, first time in human (FTIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, and preliminary efficacy of CT-202 (study drug), a humanized T cell engaging bispecific antibody targeting nectin-4, in participants with nectin-4 expressing recurrent, unresectable or metastatic refractory\u002Fresistant TNBC, CRC, or UC. Results of the study including PK, PD, efficacy, and safety will be used in the RP2D determination.",[71,97,98],"Colorectal Cancer","Urothelial Cancer","2026-08-14",{"date":38,"type":41},{"date":43,"type":22},{"date":103,"type":22},"2030-01",{"name":105,"class":48},"Context Therapeutics Inc.",3,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":125,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100514988","phase-1-study-to-assess-gtaexs617-in-participants-with-advanced-solid-tumors-100514988","NCT05985655","Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors","ELUCIDATE","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Life expectancy \\> 3 months.\n* One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive \\[HR+\\] and Human Epidermal Growth Receptor 2 negative \\[HER2-\\] that has progressed to a prior treatment with Cyclin-Dependent Kinase 4 (CDK4)\u002F Cyclin-Dependent Kinase 6 \\[CDK6\\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC).\n* Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments.\n* Adequate hematological, liver, and renal function.\n* Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.\n\nKey Exclusion Criteria:\n\n* Active and clinically significant (CS) infection.\n* Refractory nausea and\u002For vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617.\n* Symptomatic central nervous system (CNS) malignancy or metastases.\n* Concurrent active or previous malignancy.\n* Prior organ or allogeneic stem-cell transplantation.\n* Moderate or severe cardiovascular disease.\n* Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.\n* Received treatment with known strong\u002Fmoderate inhibitors and\u002For strong inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment.\n* Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study treatment.\n* Received treatment with known substrates of organic anion transporting peptide or BCRP within 14 days or 5 half-lives before the first dose of study treatment.\n* Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy\n* Has had or is scheduled to have major surgery \\\u003C28 days prior to the first dose of study treatment.\n\nNote: Other protocol Inclusion\u002FExclusion criteria may apply.",{"count":116,"type":22},230,[25,26],"The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.",[120,121,122,123,124,71],"Head and Neck Squamous Cell Carcinoma (HNSCC)","Pancreatic Adenocarcinoma","Non-small Cell Lung Cancer (NSCLC)","Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)","Hormone Receptor Positive [HR+] and Human Epidermal Growth Factor Receptor 2 Negative [HER2-] Breast Carcinoma",[126],"Advanced Solid Tumor","2026-08-11",{"date":129,"type":41},"2026-08-13",{"date":131,"type":41},"2023-07-06",{"date":133,"type":22},"2028-05",{"name":135,"class":48},"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.",15,{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":49},"100613903","phase-1-a-phase-1-multicenter-imaging-study-of-lnth-2403-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100613903","NCT07272642","A Phase 1, Multicenter Imaging Study of LNTH-2403 in Participants With Locally Advanced or Metastatic Solid Tumors.","A Phase 1, Multicenter Study of the Safety and Imaging of NTH-2403, a Lutetium-177 Radiolabeled Monoclonal Antibody Targeting the LRRC15 Epitope, in Participants With Locally Advanced or Metastatic Solid Tumors","DUNP19","Inclusion Criteria:\n\n1. Participant is willing and able to give written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n2. Participant is ≥ 18 years of age at the time of signing the informed consent.\n3. Participant has a documented history of incurable, histopathologically confirmed CRC, HNSCC,NSCLC (squamous or non-squamous histology) or TNBC with either locally advanced disease which has progressed despite (or is ineligible for) available radical standard of care treatments and has subsequently exhausted available standard of care palliative intent systemic therapies or established metastatic disease where available standard of care systemic therapies have been exhausted.\n4. Has had a SOC CT or MRI scan within 8 weeks prior to signing informed consent that indicates the presence of at least 1 site of new or residual disease. SOC baseline images must be available for submission to the centralized imaging reader as reference\n5. Participant must provide an archived tumor tissue sample.\n6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n7. Participant has at least 1 visceral lesion that has not been treated with external beam radiation therapy (EBRT).\n8. Participants of childbearing potential (CBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. Participants of CBP are defined as those who are not surgically sterile or post-menopausal. Participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Participants \\\u003C 50 years of age who meet the criteria for postmenopausal status without previous surgical sterilization should be considered for further investigation with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.\n9. Participants of CBP must agree to use a highly effective method of contraception during the study and for 3 months after the injection of LNTH-2403.\n10. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 3 months after the injection of LNTH-2403. All male participants must agree to not donate sperm during the study and for 3 months after the injection of LNTH-2403.\n\nExclusion Criteria:\n\n1. Has any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n2. Has a history of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to protein therapeutics, LNTH-2403, or any of its excipients.\n3. Has inadequate organ functions as reflected in laboratory parameters:\n\n   1. Estimated glomerular filtration rate (eGFR) (calculated using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation) ≤ 50 mL\u002Fmin\u002F1.73m2\n   2. Platelet count \\\u003C100 x 10\\^9 \u002FL\n   3. Hemoglobin \\\u003C 9 g\u002FdL\n   4. Absolute neutrophil count \\\u003C 1.0 × 109\u002FL\n   5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x upper limit of normal (ULN), or ≥ 5 x ULN for participants with known liver metastases\n   6. Total bilirubin ≥ 1.5 x ULN, except for participants with documented Gilbert's syndrome who are eligible if total bilirubin is ≤ 3 x ULN\n   7. For participants not taking warfarin or other anticoagulants: international normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ≤ 1.5 × ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C 3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n4. Has clinically significant cardiovascular\u002F cerebrovascular disease defined as cerebral vascular accident, stroke, carotid artery disease transient ischemic attack (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class \\>II) or serious cardiac arrhythmia.\n5. Has a marked baseline prolongation of QT\u002FQTc interval (repeated demonstration of a QTc interval calculated with Fredericia's correction (QTcF) \\> 470 msec for females and QTcF \\> 450 msec for males);\n6. Has a history of or has additional risk factors for torsade's de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n7. Is participating in an interventional trial or has received an investigational anticancer agent within 5 half-lives of the time of informed consent signature or is expected to enroll in an interventional trial on or before the imaging timepoint during Days 3-5.\n8. Has been treated with an LRRC15-targeted investigational product.\n9. Has had a PET scan done within 10 physical half-lives of the PET imaging agent prior to receiving study intervention.\n10. Is pregnant or breastfeeding.\n11. Had or is scheduled to have major surgery within 4 weeks of Day 1 (not including diagnostic laparoscopy).\n12. Has a medical history, physical examination, or clinical laboratory test suggestive of a condition, disorder, or disease that could adversely affect drug absorption, distribution, metabolism, or elimination of LNTH-2403, including chronic liver or renal failure.",{"count":146,"type":22},16,[25],"LNTH-2403 (177Lu-DOTA-DUNP19) is a lutetium-177 radiolabeled, fully humanized monoclonal antibody (mAb) that binds with high specificity and affinity to leucine-rich repeat containing 15 (LRRC15), a transforming growth factor (TGF) - β-driven biomarker expressed on the cell membrane of cancer cells and\u002For cancer-associated fibroblasts 9CAFs) in select tumor types. Upon binding, LNTH-2403 is rapidly internalized, such that it can serve as a dual-purpose agent for both non-invasive imaging and radiotheranostic treatment of LRRC15- positive tumors. This first-in-human (FIH) imaging study will evaluate the safety and imaging of LNTH-2403 in participants with locally advanced or metastatic solid tumors.",[150,97,151,152,71],"Imaging","Head and Neck Squamous Cell Carcinoma","Non-Small Cell Lung Cancer",[154,155,156,157,158],"imaging","colorectal cancer","Head and Neck squamous cell carcinoma,","non-small cell lung cancer,","triple negative breast cancer","2026-08-10",{"date":161,"type":41},"2026-08-12",{"date":163,"type":22},"2026-10-30",{"date":165,"type":22},"2027-10-31",{"name":167,"class":48},"Radiopharm Theranostics, Ltd",{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":176,"minAge":18,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100651336","phase-3-an-open-label-randomized-phase-iii-study-of-trastuzumab-rezetecan-with-or-without-everolimus-in-first-to-third-line-lar-subtype-tnbc-100651336","NCT07760844","An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus in First to Third Line LAR Subtype TNBC","A Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus as First- to Third-Line Treatment for Luminal Androgen Receptor Subtype of Triple-Negative Breast Cancer","SCHBCC-N0117","Inclusion Criteria:\n\n* Inclusion Criteria:\n\n  1. Female patients aged ≥18 years and ≤70 years;\n  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;\n  3. Life expectancy of at least 3 months;\n  4. Histologically confirmed invasive triple-negative breast cancer (defined as breast cancer with estrogen receptor \\[ER\\], progesterone receptor \\[PR\\], and human epidermal growth factor receptor 2 \\[HER-2\\] all determined to be negative by pathological testing. Specifically: ER-negative: IHC \\\u003C1%; PR-negative: IHC \\\u003C1%; HER2-negative: IHC -\u002F+ or IHC ++ with FISH\u002FCISH negative. All specimens must be verified as the LAR subtype of the Fudan quadruple molecular classification by the Precision Medicine Center\u002FDepartment of Pathology at the study's participating center);\n  5. Tumor stage: recurrent or metastatic breast cancer; for locally recurrent disease, radical surgical resection must be confirmed by the investigator to be not feasible. Number of prior lines of therapy in the advanced setting ≤2;\n  6. Patients must have at least one lesion (measurable and\u002For non-measurable) that has not been previously irradiated, can be accurately assessed at baseline by CT\u002FMRI, and can be repeatedly evaluated according to RECIST 1.1;\n  7. Adequate major organ function, meeting the following criteria:\n\n     Hematological parameters: hemoglobin (HB) ≥90 g\u002FL (without blood transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count (PLT) ≥75×10⁹\u002FL;Biochemical parameters: total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; in the presence of liver metastases, ALT and AST ≤5×ULN; serum creatinine (Cr) ≤1×ULN, and calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula);\n  8. No prior radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks before study initiation, and recovery from acute toxicities of prior treatment (if surgery was performed, the wound must be completely healed); no peripheral neuropathy or only grade I peripheral neurotoxicity;\n  9. Female subjects of childbearing potential must agree to use a medically accepted contraceptive method during the study treatment period and for at least 3 months after the last dose of study drug;\n  10. Subjects must voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria will be excluded from this study:\n\n  1. Known central nervous system (CNS) metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, contrast-enhanced CT or contrast-enhanced magnetic resonance imaging (MRI) must be performed within 28 days before the first dose to rule out CNS metastases;\n  2. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmias;\n  3. Persistent adverse events of Grade ≥1 resulting from prior treatment. Exceptions to this are alopecia or conditions that the investigator deems should not preclude enrollment. Such cases should be clearly documented in the investigator's notes;\n  4. Major surgery (excluding minor procedures such as placement of vascular access) within 3 weeks before the first cycle of study treatment;\n  5. Pregnant or lactating patients;\n  6. Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;\n  7. Presence of third-space fluid accumulation (e.g., massive pleural effusion or ascites) that cannot be controlled by drainage or other methods;\n  8. Participation in another anti-tumor drug clinical trial within 3 weeks before the first use of the study drug;\n  9. Long-term unhealed wounds or incompletely healed fractures;\n  10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or HBV DNA ≥500 IU\u002FmL, or chronic hepatitis with abnormal liver function;\n  11. History of allergic constitution, known allergy to any component of the study drug regimen, or history of allergy to other monoclonal antibodies;\n  12. History of gastrointestinal bleeding within the past 6 months, or clear evidence of a tendency for gastrointestinal bleeding, such as esophageal varices at risk of bleeding, active local ulcerative lesions, or fecal occult blood test ≥ (++). Patients with fecal occult blood test (+) should undergo gastroscopy;\n  13. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to study enrollment;\n  14. Urinalysis showing urine protein ≥ (++), or confirmed 24-hour urine protein quantification \\>1.0 g;\n  15. Hypertension that cannot be controlled to within normal range with antihypertensive medication (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg);\n  16. Prior use of anti-angiogenic agents or prior exposure to an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as the payload","FEMALE","70 Years",{"count":179,"type":22},180,[181],"PHASE3","This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the LAR subtype. A total of 180 patients are planned to be enrolled.",[184,71],"Breast Cancer",[158],"2026-08-07",{"date":161,"type":41},{"date":189,"type":22},"2026-10-01",{"date":191,"type":22},"2029-03-30",{"name":193,"class":194},"Fudan University","OTHER",{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":21},"100493513","phase-1-a-study-to-assess-safety-tolerability-and-imaging-characteristics-of-68gaga-dpi-4452-and-to-assess-safety-tolerability-and-efficacy-of-177lulu-dpi-4452-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100493513","NCT05706129","A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","A Multicenter, Open-Label, Non-Randomized Phase 1\u002F2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nPart A, B, and C:\n\n* Written informed consent, dated and signed by the patient prior to any study-specific procedure.\n* Part B and C are not conducted in the United States of America.\n* Has histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of:\n* Clear cell renal cell cancer (ccRCC) - participants must have received at least one line containing Tyrosine kinase inhibitor (TKI) treatment and at least one line containing immune checkpoint inhibitor treatment in metastatic setting, meaning at least two lines of treatment in metastatic setting.\n* Pancreatic ductal adenocarcinoma (PDAC) - participants must have received at least one line of platinum- and\u002For gemcitabine-based regimen.\n* Colorectal cancer (CRC) - participants must have received at least one line of FOLFIRINOX or FOLFOX\u002FFOLFIRI in two lines in combination with anti-Vascular Endothelial Growth Factor (VEGF) or anti-Epidermal Growth Factor Receptor (EGFR).\n* Participants with CRC or PDAC: availability of fresh biopsy, OR an archival biopsy\u002Fsurgical specimen of the tumor (preferably, taken after last prior line of therapy).\n* For Part B and C only: Urothelial cancer (UC) patients must have received all available standard of care if eligible, including one line of platinum-based chemotherapy, enfortumab vedotin and pembrolizumab.\n* Presence of at least 1 non-irradiated tumor lesion detected at conventional imaging (computed tomography \u002F magnetic resonance imaging (CT\u002FMRI)) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration.\n* Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nPart D:\n\nParticipants with imaging evidence of a single indeterminate renal mass (IDRM) of ≤ 7 cm in largest diameter (tumor stage cT1) on any conventional diagnostic imaging technique, suspicious for ccRCC and planned for total or partial nephrectomy, or interventional diagnostic (cystoscopy and retrograde pyelography or biopsy) within 90 days from planned \\[68Ga\\]Ga-DPI-4452 administration.\n\nPart E:\n\nRegardless of lines of treatment, participants with histologically or cytologically confirmed progressive, unresectable locally advanced or metastatic solid tumors of\n\n* UC, including MIBC\n* H\\&N cancer\n* TNBC\n* Squamous NSCLC\n* Any other indication with confirmed carbonic anhydrase IX (CA IX) expression excluding ccRCC, PDAC and CRC, upon Sponsor agreement.\n\nPresence of at least 1 non-irradiated tumor lesion detected at conventional imaging (CT\u002FMRI) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration (for scans dated more than 4 weeks prior to D1, the Sponsor should be contacted to assess conventional imaging suitability)\n\nExclusion Criteria:\n\n* Any major surgery within 12 weeks before enrolment.\n* Inability to stay in the scanner bed with the arms resting out of the thoracic and abdominal fields (i.e., arms alongside the body or raised arm position) for the duration of the scan.\n\nPart A:\n\n* Has known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, and\u002For stable Grade 2 sensory neuropathy, according to National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\]).\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Previous Carbonic anhydrase (CA) IX-targeting treatment.\n* Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow, as judged by the Investigator.\n\nPart B and Part C:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, active clinically significant cardiac disease, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, or stable Grade 2 sensory neuropathy, according to NCI-CTCAE).\n* Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment for non-oncological indication within 3 months prior to the \\[177Lu\\]Lu-DPI-4452 infusion; any previous CA IX-targeting treatment for any oncological indication.\n* Participants who received any systemic antineoplastic therapy for the underlying disease and\u002For other investigational agents within a period which is ≤5 half-lives or ≤4 weeks (whichever is shorter).\n* Inflammatory bowel disease (e.g Crohn's disease, ulcerative colitis, etc).\n\nPart D:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Any previous CA IX-targeting treatment within 3 months prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n* Ongoing treatment with sulfonamides and\u002For coumarin derivatives (e.g., acenocoumarol, warfarin, phenprocoumon) within 2 weeks (or 5 half-lives, whichever is longer) prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n\nPart E:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment within 3 months prior to \\[68Ga\\]Ga-DPI-4452 injection.\n* EBRT to more than 25% of the bone marrow, as judged by the Investigator.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n\nNote: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.",{"count":203,"type":22},270,[25,26],"The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \\[68Ga\\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \\[maximum tolerated dose (MTD) or lower dose\\] for \\[177Lu\\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \\[177Lu\\]Lu-DPI-4452 as monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \\[68Ga\\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \\[68Ga\\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.",[207,208,209,210,211,212,213,71,214],"Clear Cell Renal Cell Cancer (ccRCC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Colorectal Cancer (CRC)","Urothelial Carcinoma (UC)","Indeterminate Renal Mass (IDRM)","Muscle Invasive Bladder Cancer (MIBC)","Head and Neck Cancer (H&N)","Squamous Non-Small Cell Lung Cancer (NSCLC)",{"date":127,"type":41},{"date":217,"type":41},"2023-03-14",{"date":219,"type":22},"2029-03",{"name":221,"class":48},"Lumara Bio Oncologics GmbH",{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":245,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100647108","a-study-of-shy-onc6-a-novel-proteasome-inhibitor-in-adults-with-advanced-or-metastatic-solid-tumors-100647108","NCT07705334","A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors","A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SHY-ONC6 in Participants With Advanced or Metastatic Solid Tumors","Luca-1","Inclusion Criteria:\n\n* Male or female ≥18 years of age.\n* Life expectancy \\>3 months.\n* ECOG performance status 0-1.\n* Histologically\u002Fcytologically confirmed advanced or metastatic solid tumors that have progressed on or are intolerant\u002Funsuitable for standard therapies. Eligible tumor types: TNBC, HR+ breast cancer, colon cancer, gastric cancer, HCC, NSCLC (adeno and squamous), mesothelioma, pancreatic cancer, HRPC, soft tissue sarcoma; other tumor types after Medical Monitor discussion. Stable CNS metastases ≥4 weeks post-radiotherapy and off steroids ≥14 days are permitted.\n* ≥1 measurable lesion per RECIST v1.1 (prostate cancer with bone-only disease and elevated PSA assessed by PCWG3).\n* Accessible tumor for biopsy\n* Adequate organ\u002Fbone marrow function.\n* Willingness and ability to provide informed consent.\n* Negative serum pregnancy test and use of effective contraception through 90 days after last dose for women of childbearing potential.\n* Male participants must use barrier contraception or abstinence and not donate sperm through 90 days after last dose.\n\nExclusion Criteria:\n\n* High-risk cardiovascular disease.\n* Concurrent anti-cancer treatment.\n* Active infection requiring systemic treatment within 2 weeks pre-dose.\n* History of another malignancy (with standard exceptions for in situ disease, non-melanoma skin cancers, and remission ≥2 years).\n* Active HBV (HBV-DNA \\>ULN), HCV (HCV-RNA \\>ULN), or HIV (well-controlled HIV with CD4 ≥350 cells\u002FµL and undetectable viral load permitted); AIDS-defining opportunistic infection within 12 months.\n* Compromised pulmonary function within 6 months pre-dose .\n* Pregnancy or breastfeeding.\n* Recent radiotherapy, systemic anti-tumor therapy, other investigational therapy without appropriate washout.\n* Major surgery ≤4 weeks pre-dose.\n* Unable to swallow tablets or conditions affecting GI absorption.\n* Any medical or psychiatric disorders affecting compliance and\u002For interpretation of study results.\n* Persistent toxicities from prior anti-cancer therapy (exceptions apply)\n* Clinically significant corneal disease.\n* Unable to comply with prohibited concomitant medication restrictions.",{"count":231,"type":22},30,[25],"This is a Phase 1, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SHY-ONC6 in participants with advanced or metastatic solid tumors who have progressed on or are intolerant to standard therapies. The study will consist of 2 parts: a dose escalation part (Phase 1a) and a dose expansion part (Phase 1b).",[235,71,236,237,238,239,240,241,242,243,244],"Advanced or Metastatic Solid Tumors","HR+ Breast Cancer","Colon Cancer","Gastric Cancer","Hepatecellular Carcinoma","NSCLC (Advanced Non-small Cell Lung Cancer)","Mesothelioma","Pancreatic Carcinoma Metastatic","Hormone Refractory Prostate Cancer","Soft Tissue Sarcomas",[246,247],"Proteasome Inhibitor","Solid Tumors","2026-08-06",{"date":159,"type":41},{"date":251,"type":41},"2026-06-24",{"date":253,"type":22},"2028-05-15",{"name":255,"class":48},"SHY Therapeutics",4,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":176,"minAge":18,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":270,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":49},"100650753","phase-2-retlirafusp-alfa-combined-with-chemotherapy-or-fuzuloparib-for-triple-negative-breast-cancer-100650753","NCT07752550","Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer","Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer: An Exploratory Clinical Study","Inclusion Criteria:\n\n1. Age ≥18 years, female;\n2. Histopathologically confirmed recurrent or metastatic triple-negative breast cancer, defined as ER-negative (IHC ER-positive percentage \\\u003C1%), PR-negative (IHC PR-positive percentage \\\u003C1%), and HER2-negative (IHC -\u002F+ or IHC ++ but FISH\u002FCISH -);\n3. At least one measurable lesion per RECIST version 1.1 criteria;\n4. Advanced cohort:\n\n   Metastatic or unresectable locally advanced TNBC (no prior systemic therapy or completed neoadjuvant\u002Fadjuvant therapy ≥12 months); PD-L1 positive with a Combined Positive Score (CPS) ≥1;\n\n   Neoadjuvant cohort:\n\n   Clinical stage II (T2N0-1M0\u002FT3N0M0) or III (T2N2-3M0\u002FT3N1-3M0) previously untreated breast cancer patients;\n5. Life expectancy ≥3 months;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n7. Available tissue sample for testing, and gBRCA1\u002F2 mutation status must be determined prior to treatment;\n8. Adequate major organ function meeting the following criteria (no blood transfusion or use of granulocyte colony-stimulating factor or thrombopoietin within 2 weeks prior to screening):\n\n   Hematologic: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count (PLT) ≥90×10⁹\u002FL; hemoglobin (Hb) ≥90 g\u002FL; Biochemical: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); ALT and AST ≤1.5× ULN (≤3× ULN for patients with liver metastases); alkaline phosphatase ≤2.5× ULN; BUN and creatinine ≤1.5× ULN with creatinine clearance ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula); Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should also be assessed; patients with normal T3 and T4 levels may be enrolled); Echocardiography: Left ventricular ejection fraction (LVEF) ≥50%; 18-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \\\u003C480 ms for females;\n9. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use adequate contraception during the study period and for at least 4 months after the last dose of study drug;\n10. Willing to participate, capable of providing signed informed consent, and compliant with study procedures.\n\nExclusion Criteria:\n\n1. Concurrently receiving anti-tumor therapy in another clinical trial;\n2. Received other anti-tumor therapy within 4 weeks prior to the first dose of study drug;\n3. Prior treatment with tumor immunotherapy (including but not limited to PD-1, PD-L1, CTLA-4 inhibitors, etc.) or TGF-β inhibitors;\n4. Prior treatment with PARP inhibitors (except for patients who completed PARP inhibitor therapy for ovarian cancer ≥5 years ago with no recurrence or metastasis);\n5. Untreated active brain metastases or leptomeningeal metastases;\n6. Underwent major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or have not fully recovered from such surgery;\n7. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); patients with vitiligo or childhood asthma that has completely resolved and does not require any intervention in adulthood may be included; patients with asthma requiring bronchodilator therapy for medical intervention are excluded;\n8. Severe cardiac disease or conditions, including but not limited to: documented history of heart failure or systolic dysfunction (LVEF \\\u003C50%); uncontrolled high-risk arrhythmias, such as atrial tachycardia, resting heart rate \\>100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (i.e., Mobitz II second-degree or third-degree atrioventricular block); angina requiring anti-anginal medication; clinically significant valvular heart disease; ECG showing transmural myocardial infarction; poorly controlled hypertension (systolic blood pressure \\>180 mmHg and\u002For diastolic blood pressure \\>100 mmHg);\n9. Congenital or acquired immunodeficiency (e.g., HIV-infected patients);\n10. Received live vaccine within 4 weeks prior to study drug administration or likely to receive such vaccine during the study period;\n11. Known hypersensitivity to any component of the study drugs in this protocol;\n12. Severe concomitant disease or other comorbidities that may interfere with the planned treatment, or any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.","100 Years",{"count":266,"type":22},120,[26],"To investigate the efficacy and safety of Retlirafusp alfa in combination with chemotherapy or fluzoparib for early-stage and advanced triple-negative breast cancer.",[29],[271,272,273],"Triple-negative breast cancer","Retlirafusp alfa","Fluzoparib","2026-08-04",{"date":186,"type":41},{"date":277,"type":22},"2026-07-30",{"date":279,"type":22},"2029-07-30",{"name":281,"class":194},"Harbin Medical University",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":177,"enrollmentInfo":289,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":292,"conditions":293,"keywords":297,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100650238","phase-1-a-study-of-iov-5001-in-adults-with-advanced-solid-tumors-100650238","NCT07743723","A Study of IOV-5001 in Adults With Advanced Solid Tumors","A Phase 1\u002F2, Multicenter, Multi-cohort, Open-label Study of an Autologous Tumor-infiltrating Lymphocytes (TIL) Regimen With IOV-5001 in Participants With Previously Treated Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participant must be ≥ 18 years of age at the time of signing the informed consent.\n2. Diagnosis:\n\n   NSCLC: Participant has a histologically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC (squamous, nonsquamous, adenocarcinoma, large cell, or mixed histologies) without epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 (ROS1) genomic alterations.\n\n   TNBC: Participant has a histologically or pathologically confirmed diagnosis of unresectable or Stage IV breast cancer.\n\n   CRC: Participant has a histologically or pathologically confirmed diagnosis of Stage IV CRC.\n\n   HNSCC: Participant has a histologically or pathologically confirmed diagnosis of Stage III or IV HNSCC not amenable to curative intent treatment.\n3. Radiographic disease progression: Participant has radiographic disease progression after the most recent line of therapy.\n4. Disease-specific criterion:\n\n   NSCLC: Radiographic disease progression occurred:\n   * After having received platinum-based chemotherapy and an immune checkpoint inhibitor, either administered concurrently or sequentially for Stage IV disease.\n   * Within 6 months of completion of the platinum component of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and having progressed after receiving an immune checkpoint inhibitor in the neoadjuvant, adjuvant, or metastatic setting.\n\n   TNBC: Participant has received up to 3 prior lines of therapy. These must include at least one prior line of cytotoxic chemotherapy for unresectable or Stage IV breast cancer, regardless of ER, PR, or HER2 status at the time it was given.\n\n   CRC: Participant has received up to 3 prior lines of therapy. These must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, an anti-EGFR therapy (for RAS\u002Frapidly accelerated fibrosarcoma \\[RAF\\] wild-type disease if the tumor originated in the left side of the colon), and an immune checkpoint inhibitor (for microsatellite instability high \\[MSI-H\\] or deficient mismatch repair \\[dMMR\\] disease.\n\n   HNSCC: Participant has received up to 3 prior lines of therapy. These must include an immune inhibitor and platinum-based chemotherapy unless platinum ineligible due to pre-existing hearing loss, Grade \\>= 2 tinnitus, Grade \\>= 2 peripheral neuropathy, or allergy to platinum.\n5. Disease-specific criterion:\n\n   NSCLC: Participant has received up to 3 lines of prior therapy. These must include an appropriate health authority-approved targeted therapy for participants who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations) if eligible and available.\n\n   TNBC: Participant has progressed on or is ineligible for other standard of care therapies including, but not limited to: sacituzumab govitecan, poly(ADP-ribose) polymerase (PARP) inhibitors (if breast cancer gene \\[BRCA\\]1 or BRCA2 mutated), trastuzumab deruxtecan (if HER2low), and pembrolizumab (for PD-L1 combined positive score \\[CPS\\] \\>= 10).\n\n   CRC: Microsatellite instability and\u002For mismatch repair mutational status must have been previously determined based on archival tumor biopsies.\n\n   HNSCC: Participant has documented PD-L1 status.\n6. The participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of \\> 6 months.\n7. Participant is assessed as having at least one resectable lesion (or aggregate lesions) with an estimated minimum diameter of 1.5 cm (short axis) for IOV-5001 generation.\n\nExclusion Criteria:\n\n1. Participants with symptomatic untreated brain metastases. Participants with brain metastases may be enrolled with considerations and discussion with medical monitor.\n2. Participant has an active medical illness(es) that, in the opinion of the investigator would pose increased risks for study participation. Participant has evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or identified during screening.\n3. Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease \\[SCID\\] or AIDS).\n4. Participant has a history of hypersensitivity to any component of the study intervention.\n5. Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or have been curatively treated \\> 1 year ago, and in the judgment of the investigator does not pose a significant risk of recurrence including, but not limited to: in situ carcinoma of the cervix, early stage skin cancer, including non-melanoma skin cancer, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of the breast, prostate cancer with Gleason score ≤ 6, or superficial bladder cancer).\n6. Participant has a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.\n7. Participant requires systemic steroid therapy \\> 10 mg\u002Fday of prednisone or another steroid equivalent dose. Participants receiving steroids as replacement therapy for adrenocortical insufficiency at ≤ 10 mg\u002Fday of prednisone or another steroid equivalent dose may be eligible.\n8. Participant received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD preparative regimen.\n9. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.",{"count":290,"type":22},106,[25,26],"A Phase 1\u002F2, multicenter, multi-cohort, open-label study of an autologous tumor-infiltrating lymphocytes (TIL) regimen with IOV-5001 in participants with previously treated advanced solid tumors",[294,152,71,97,151,295,296],"Advanced Solid Tumors","Metastatic Solid Tumors","Unresectable Solid Tumor",[298,299,294,71,295,300,301,209,120],"TIL","Tumor Infiltrating Lymphocytes","Unresectable Solid Tumors","Non-Small Cell Lung Cancer (NSCLC)","2026-08-03",{"date":248,"type":41},{"date":305,"type":22},"2026-08",{"date":307,"type":22},"2044-03",{"name":309,"class":48},"Iovance Biotherapeutics, Inc.",{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":176,"minAge":18,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":339},"100641604","phase-1-phase-1-study-of-a-self-amplifying-rna-vaccine-iti-5000-in-stage-2-3-triple-negative-breast-cancer-100641604","NCT07652242","Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer","A Phase 1, Multicenter, Open-label, First-in-Human Study of ITI-5000 (Self-Amplifying RNA Vaccine) Alone and in Combination With Standard of Care Adjuvant Therapy in Participants With Stage II-III Triple-Negative Breast Cancer (TNBC)","VITAL-TNBC","Inclusion Criteria:\n\n1. Applicable to Part A only. Participants must have completed adjuvant pembrolizumab if they were receiving it before enrolling in the study.\n2. Applicable to Cohort 3A and Part B only. Participant must have received neoadjuvant chemotherapy with pembrolizumab, then undergone definitive surgery. At the time of surgery, participant must not have achieved pCR.\n3. Applicable to Part B only. Participant is currently receiving or is planned to receive standard of care adjuvant therapy, including pembrolizumab in combination with capecitabine or olaparib in accordance with the FDA-approved label, with ≥3 cycles remaining if receiving 200mg Q3W or ≥2 cycles remaining if receiving 400 mg Q6W at the time of first ITI-5000 dose.\n4. Adults aged 18 years or over.\n5. Participants provided a signed and dated ICF.\n6. Participant agrees not to receive any routine vaccinations until at least 30 days after receiving the last study vaccine.\n7. TNBC diagnosed as pathologic stage 2-3 according to American Joint Committee on Cancer (AJCC) and confirmed by histological examination, e.g., negative for HER2 as defined by ASCO CAP 2023 guidelines. ER and PgR receptor negative by immunohistochemistry. Participants with BRCA mutations will be allowed.\n\n   a. Concurrent endocrine therapy (e.g., tamoxifen, aromatase inhibitors, ovarian suppression) is not permitted during study participation. Concurrent CDK4\u002F6 inhibitors (ribociclib\u002Fabemaciclib) are not allowed.\n8. Applicable to Part A only. Participants with more than 4 weeks since last active therapy (chemotherapy, radiation therapy, or surgery) and 36 months or less following definitive surgery, based on the period of highest risk for recurrence in participants with stages 2-3 TNBC.\n9. Applicable to Part A only. Participants completed all planned previous cancer treatment (e.g., chemotherapy, radiation, therapy, surgery).\n10. Participant's ECOG performance status is 0 or 1.\n11. Participant had no significant ischemic heart disease or myocardial infarction within 3 months before vaccination #1 and has adequate cardiac function during eligibility evaluation, as evidenced by QTc of ≤470 msec for females or ≤450 msec for males assessed by the Fridericia method (QTcF) and evidenced by the average of measurements from triplicate ECGs at the screening visit.\n\n    a. The eligibility of participants with ventricular pacemakers for whom the QT interval may not be accurately measurable will be determined on a case-by-case basis by the sponsor in consultation with the medical monitor.\n12. Participant has an adequate organ function, as evidenced by the following tests conducted within 7 days before enrollment:\n\n    i. Hematology examination (excluding blood transfusion or use of hematopoietic stimulating agents for correction):\n\n1\\. Hemoglobin ≥8.0 g\u002FL 2. Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL 3. Platelet count ≥100 × 109\u002FL ii. Serum biochemistry examination (excluding recent blood transfusion or albumin administration):\n\n1\\. Alanine aminotransferase and AST ≤1.5 times the ULN 2. Alkaline phosphatase ≤2.5 ULN 3. Total bilirubin ≤ 1.5 ULN 4. Serum creatinine ≤1.5 ULN, with creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula) 13. Women of childbearing potential have a negative serum pregnancy test within 3 days before vaccination #1, and they and their partners agree to use highly effective methods of contraception during the study and for 6 months after the last administration of the study drug.\n\na. NOTE: A woman is considered of non-childbearing potential if she has had a documented bilateral oophorectomy, tubal ligation, or hysterectomy, or if she is postmenopausal, defined as ≥12 months of spontaneous amenorrhea without an alternative medical cause (with serum FSH confirmation if \\\u003C55 years old). 14. Participant is able to attend the required study visits and follow-up as required by this protocol.\n\n15\\. Participant is able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines prior to study registration.\n\n16\\. Participant agrees not to use alternative therapies from the time of informed consent through 30 days following vaccination #3. Participants may be asked to complete a \"wash out\" period before vaccination #1 at the principal investigator's discretion to ensure the absence of all alternative therapies.\n\nNOTE: \"Alternative therapies\" refer to non-prescription or non-standard medical interventions used with the intent to treat or prevent cancer or its symptoms, including but not limited to herbal remedies, high-dose dietary supplements marketed for therapeutic benefit, homeopathic preparations, or naturopathic treatments. Routine vitamins, minerals, or supportive care measures not expected to affect immune function may be continued at the investigator's discretion.\n\nExclusion Criteria:\n\n1. Applicable to Part B only. Participant discontinued prior treatment with an ICI due to irAEs.\n2. Participant underwent major surgery within 4 weeks before the planned day of vaccination #1 or received any other investigational drug or device within 4 weeks or 5 half-lives of that agent (whichever is shorter) before the planned day of Vaccination #1.\n\n   i. Applicable to Part A only. Participant received cancer-directed therapy (chemotherapy, radiotherapy, biologic or immunotherapy, etc.) within 4 weeks or 5 half-lives of that agent (whichever is shorter) before the planned day of Vaccination #1. ii. Applicable to Part B only. Participants who received any PD-1 or PD-L1 inhibitor other than pembrolizumab will be excluded unless they have completed a washout period of ≥ 4 weeks or 5 half-lives of that agent (whichever is shorter) before Vaccination #1.\n3. Participant has toxicities due to prior immunotherapy. For the participant to be eligible, these toxicities must either have returned to ≤ Grade 1 or baseline or been deemed irreversible and in the opinion of the investigator not worsened by immunotherapy (e.g., ICI-endocrinopathies). Participants with any cardiac toxicities (regardless of the grade, etc.) will be excluded.\n4. Participant has toxicities due to prior chemotherapy that have not been resolved or considered stable and clinically manageable (e.g., neuropathies). Participants with any cardiac toxicities will be excluded.\n5. Participant has a significant medical illness, underlying health condition, or abnormal laboratory finding that, in the investigator's opinion, would increase the risk of participating in the study.\n6. Participants with an active autoimmune disease requiring immunosuppressive treatment within the last year (excluding irAEs), such as chronic prolonged systemic corticosteroid use (defined as corticosteroid use lasting one month or more).\n7. Female participants who are trying to conceive, are pregnant, or lactating.\n8. A positive serum pregnancy test at screening and\u002F or a positive human chorionic gonadotropin (hCG) urine test at baseline in women of childbearing potential.\n9. Participant concurrently participates in any other interventional clinical trial.\n10. Participant has known allergies to any of the components of the study vaccine.\n11. Participant has a history of anaphylaxis requiring medical intervention (including severe reactions to other mRNA vaccines, such as those against SARS-COV-2, etc.).\n12. Participant has a history of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to the first dose of study treatment.\n13. Participant has a history of myocarditis or pericarditis.\n14. Participant has symptomatic congestive heart failure according to New York Heart Association (NYHA) classification, Class III or IV (per NYHA Classification), clinically significant cardiac arrhythmia, or a known left ventricular ejection fraction \\\u003C45%.\n15. Participant has a history of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome) or requires the use during study participation of concomitant medications known or suspected to prolong the QT\u002FQTc interval, with the exception of drugs with low risk of QT\u002FQTc prolongation that are used as standard premedication (e.g., diphenhydramine, famotidine, ondansetron).\n16. Participant received an mRNA or a live virus vaccine within 28 days of the planned vaccination #1. Flu and COVID vaccinations\u002Fboosters are also prohibited within 28 days before the planned day of vaccination #1. Vaccines that do not contain live virus are permitted.\n17. Participant has prior malignancy, except for the following:\n\n    i. adequately treated basal-cell or squamous-cell skin cancer, ii. in situ cervical cancer, iii. any other cancer from which the participant has been disease-free for at least 3 years.\n18. Participant has a history of organ transplant requiring immunosuppression. Participants with unstable human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) are not eligible.\n\n    a. Stable and well controlled HIV\u002FAIDS participants on retroviral therapy, defined as those with no dose change within 4 weeks before the planned day of vaccination #1 and no anticipated dose change, are eligible.\n19. Participant with known active hepatitis B or C are not eligible. Active hepatitis B is defined as a known positive hepatitis B surface antigen (HBsAg) result. Active hepatitis C is defined by a known positive hepatitis C antibody result and known quantitative hepatitis C virus RNA results greater than the lower limits of detection of the assay.\n\n    a. Participants with a history of infection with hepatitis B virus or HCV may enroll if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and\u002For nucleic acid testing.\n20. Participant was assessed by the investigator as being unable or unwilling to comply with the requirements of the treatment schedule and study procedures for any reason.\n21. Participant has a contraindication to IM injections or blood draws.",{"count":319,"type":22},60,[25],"This study tests an investigational cancer vaccine called ITI-5000 in people who have completed standard treatment for early-stage triple-negative breast cancer (TNBC).\n\nITI-5000 is a self-amplifying RNA (saRNA) vaccine that instructs the immune system to recognize and attack cancer cells expressing two proteins found on TNBC cells-HERV-K and CT83-fused with a molecule called LAMP-1 that helps the immune system respond more strongly. The vaccine is delivered inside lipid nanoparticles (LNPs), similar to other approved mRNA vaccines.\n\nThe study has two parts:\n\n* Part A: Participants receive ITI-5000 alone at one of two dose levels (1 µg or 10 µg), given as an injection into the upper arm muscle every 28 days for 3 doses total. The goal is to find the safest dose.\n* Part B: Participants receive ITI-5000 at the best dose identified in Part A, combined with the following approved immunotherapy drugs pembrolizumab (Keytruda) and either olaparib or capecitabine.",[71],[324,325,326,327,328,329,330,331],"TNBC","saRNA","Pembrolizumab","Phase I Clinical Trial","Immunotherapy","HERV-K","First in Human (FIH)","CT83",{"date":302,"type":41},{"date":334,"type":22},"2026-06",{"date":336,"type":22},"2028-08",{"name":338,"class":48},"Immunomic Therapeutics, Inc.",2,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":23,"phases":350,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":363,"leadSponsor":365,"locationsCount":339},"100650006","phase-2-a-phase-ii-study-of-biomarker-guided-de-escalation-using-anthracycline-free-neoadjuvant-chemoimmunotherapy-in-early-stage-triple-negative-breast-cancer-tnbc-patients-with-high-tumor-infiltrating-lymphocytes-tils-100650006","NCT07743190","A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs)","NeoTILs: A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs)","NeoTILs","Inclusion Criteria:\n\nPre-Screening Phase:\n\n1. Age ≥ 18 years at the time of informed consent.\n2. Ability to understand and willingness to sign a written informed consent document in accordance with institutional and federal guidelines.\n3. Histologically confirmed diagnosis of triple-negative breast cancer (TNBC) or hormone receptor-low invasive breast carcinoma, with clinical anatomic Stage II or Stage IIIA\u002FB as defined by the AJCC 8th Edition Anatomic Breast Cancer Staging System.\n\n   a. Invasive tumor must be estrogen receptor (ER) and\u002For progesterone receptor (PR) negative or low, defined as ≤10% positive staining by immunohistochemistry (IHC).\n\n   b. HER2-negative disease, defined in accordance with current ASCO-CAP HER2 testing guidelines.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n\nScreening and Treatment Phases:\n\nGeneral Eligibility\n\n1. Individuals of childbearing potential must be willing and able to use highly effective contraception from the time of informed consent, throughout study treatment, and for at least 6 months after the last dose of trial therapy.\n\n   a. NOTE: Highly effective contraception is defined as methods with a failure rate \\\u003C1% per year when used consistently and correctly, and include: copper intrauterine device (IUD); bilateral tubal ligation\u002Focclusion or other documented surgical sterilization; vasectomized partner with documented azoospermia, provided this is the sole sexual partner; or true sexual abstinence, defined as complete abstinence from heterosexual intercourse, when this is the participant's usual and preferred lifestyle. Use of hormonal contraceptive methods (including combined oral contraceptives, progestin-only pills, injectables, implants, hormonal IUDs, patches, or vaginal rings) is not permitted during the study and for at least 6 months after the last dose of study treatment.\n2. Willingness and ability to comply with all study procedures, including scheduled visits, treatment plans, laboratory tests, and other protocol-specified requirements.\n3. Willingness and ability to sign and date written informed consent prior to initiation of any study-specific procedures.\n\n   Disease Characteristics\n4. Breast and axillary imaging (mammogram, ultrasound, or MRI) must have been completed within 45 days prior to registration.\n5. Patients with abnormal axillary lymph nodes (identified clinically and\u002For radiographically) must undergo routine pathological confirmation via image-guided core biopsy or fine needle aspiration.\n6. Presence of:\n\n   1. Measurable disease in the breast measuring at least 1cm with or without nodal involvement; or\n   2. Clinical T0 disease with biopsy-proven regional lymph node involvement (cT0N1-2M0), consistent with an overall anatomic stage II-IIIB classification.\n\n   i. For patients with clinical T0 disease confirmed by mammogram\u002FUS and MRI, nodal involvement must be documented by core needle biopsy or fine needle aspiration of an axillary or other regional lymph node demonstrating invasive breast carcinoma prior to initiation of neoadjuvant systemic therapy.\n\n   ii. Patients must not have undergone prior surgical excision of an invasive breast primary tumor that would account for the T0 designation (i.e., T0 must not be the result of complete prior excision of the primary breast lesion).\n7. Patients with multifocal or multicentric disease are allowed if the dominant tumor is confirmed ER and\u002For PR ≤10%, and HER2-negative.\n8. Patients with bilateral breast cancer are eligible if both tumors are HER2-negative.\n9. Staging scans (e.g., CT chest\u002Fabdomen\u002Fpelvis with a nuclear bone scan) must be performed to rule out metastatic disease under any of the following conditions:\n\n   a. Two or more abnormal axillary lymph nodes on imaging, or b. Clinical suspicion of metastatic disease, or c. At the discretion of the treating physician.\n\n   Clinical and Laboratory Requirements\n10. Peripheral neuropathy must be Grade ≤1 per CTCAE v5.0.\n11. Complete history and physical examination performed within 45 days prior to registration.\n12. Adequate hematologic and organ function as defined by the following:\n\n    a. Hematologic i. Hemoglobin ≥9.0 g\u002FdL (without transfusion or erythropoietin support within 14 days prior to testing) ii. Leukocytes ≥3,000\u002FμL iii. Absolute neutrophil count (ANC) ≥1,500\u002FμL iv. Platelet count ≥100,000\u002FμL b. Hepatic i. AST (SGOT) and ALT (SGPT) ≤3 × ULN ii. For participants without a history of Gilbert's syndrome, total bilirubin ≤1.5 × upper limit of normal (ULN) iii. For participants with a history of Gilbert's syndrome, total bilirubin ≤5 × ULN c. Renal i. Serum creatinine ≤1.5 mg\u002FdL or creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m² by Cockcroft-Gault formula.\n\n    ii. Note: Patients with creatinine clearance 30-50 mL\u002Fmin may be enrolled at the discretion of the Principal Investigator, given that paclitaxel is primarily hepatically metabolized and carboplatin dosing can be adjusted to renal function.\n13. Cardiac function must be within acceptable limits, as follows: left ventricular ejection fraction (LVEF) ≥50% by\n\n    a. Echocardiogram (ECHO), or b. Multi-gated acquisition (MUGA) scan.\n14. Participants with known human immunodeficiency virus (HIV)-infection must be on effective antiretroviral therapy (ART) at randomization and have an undetectable viral load test on the most recent test results obtained within six (6) months prior to randomization.\n15. Participants with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within six (6) months prior to randomization, if indicated.\n\n    a. NOTE: No testing for HBV is required unless mandated by local health authority.\n16. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have an undetectable HCV viral load test on the most recent test results obtained within six (6) months prior to randomization, if indicated.\n\n    1. NOTE: No testing for HCV is required unless mandated by local health authority.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\nPre-Screening Phase:\n\n1\\. Presence of tumor-infiltrating lymphocytes (TILs) \\\u003C30% based on central pathology review of hematoxylin and eosin (H\\&E) stained slides.\n\nScreening and Treatment Phases:\n\nDisease-Related Exclusions\n\n1. Presence of N3, inflammatory, or metastatic (M1) breast cancer.\n2. History of other malignancies within the past 3 years, with the exception of:\n\n   1. Adequately treated non-melanoma skin cancer, or\n   2. Cervical carcinoma in situ, or\n   3. Other malignancies with a ≥3-year disease-free interval. Prior and Concurrent Therapy\n3. Prior systemic therapy, radiation therapy, or definitive surgery for current breast cancer.\n4. Prior treatment with immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, or any other T-cell co-inhibitory or co-stimulatory agents.\n5. Use of investigational agents or devices within 28 days prior to registration\n6. Participant is planning to participate, currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n\n   Medical Conditions\n7. History of severe (Grade ≥3) allergic reactions or hypersensitivity to study drugs or their components.\n8. Uncontrolled diabetes mellitus or hypertension.\n9. 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 (7-day clearance period for immunosuppressant therapy prior to starting study treatment, if applicable).\n10. History of solid organ transplant.\n11. Active autoimmune disease requiring systemic treatment within the past 1 year.\n12. Recent (within 12 weeks) or active non-infectious pneumonitis requiring corticosteroid therapy.\n13. Major surgical procedure or active\u002Fsevere infection within 14 days prior to registration.\n14. Subject is a WOCBP who has had a positive pregnancy test within 24 hours prior to initiation of study treatment. Females will be determined to be not of child-bearing potential with a history of hysterectomy or with postmenopausal status of \\>12 months.\n15. Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 180 days after the last dose of trial treatment.\n16. History of hypersensitivity to compounds that are similar to carboplatin and paclitaxel.\n17. Has received major surgery and has not recovered adequately from the toxicity and\u002For complications before starting study treatment.\n18. Has a history of non-infectious pneumonitis that required high-dose steroids and\u002For has current pneumonitis.\n19. Has an active bacterial infection requiring systemic therapy.\n20. Known psychiatric or substance abuse disorders that would interfere with the requirements of the trial.\n\n    Vaccination\n21. Administration of live vaccines within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza or COVID vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.",{"count":349,"type":22},55,[26],"This study tests a new treatment approach for people with early-stage triple negative breast cancer whose tumors have a high number of immune cells, called tumor-infiltrating lymphocytes or TILs, as seen by a pathologist on tissue review. A high TIL count is a sign the cancer may respond especially well to chemotherapy and immunotherapy together, meaning more toxic treatment may not be needed for everyone.\n\nAll patients with high TILs will receive 12 weeks of chemotherapy (carboplatin and paclitaxel) with the immunotherapy drug pembrolizumab before surgery, without anthracyclines, a class of chemotherapy drugs that is effective but carries risks of heart damage and, rarely, bone marrow disorders or leukemia. Patients with no cancer found at surgery continue on pembrolizumab alone. Those with residual cancer receive anthracycline-based chemotherapy plus pembrolizumab, closer to current standard treatment.\n\nThe goal is to personalize treatment, sparing anthracyclines for patients likely to do well without them while reserving stronger therapy for those who need it. The main measure of success is the pathologic complete response rate, with cancer-free survival and overall survival also assessed.",[71,353],"Elevated Tumor-Infiltrating Lymphocytes",[31,355,356,357,298,358,359],"Neoadjuvant chemoimmunotherapy","Neoadjuvant treatment","TILs","anthracycline sparing","non-anthracycline based","2026-07-29",{"date":302,"type":41},{"date":189,"type":22},{"date":364,"type":22},"2030-03-01",{"name":366,"class":194},"Medical University of South Carolina",{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":383,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":49},"100642407","phase-1-phase-i-study-of-jfi447-68gaga-dfc413-and-comparison-to-ffg233-68gaga-nns309-in-patients-with-solid-tumors-100642407","NCT07630961","Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Phase I, Open Label First in Human Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of JFI447 [68Ga]Ga-DFC413, and Compare to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all of the following criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Age ≥ 18 years old.\n3. ECOG performance status ≤ 2.\n4. Patients with one of the following indications (regardless of lines of prior therapy):\n\n   Locally advanced unresectable or metastatic PDAC, NSCLC, HR+\u002FHER2- ductal or lobular BC, TNBC, CRC or STS.\n5. Patients must have at least one measurable lesion per RECIST v1.1 as measured by local Investigator (by conventional MRI or CT scan).\n6. Patients must have an available archival tumor sample at the screening visit. If multiple archival tumor samples are available, the most recent will be requested. Exceptions may be made after documented discussion with Novartis.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Out-of-range laboratory values defined as:\n\n   * Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin (calculated using CKD-EPI 2021 formula, or measured based on 24-hour urine collection)\n   * Total bilirubin \\> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \\> 3.0 x ULN) or direct bilirubin \\> 1.5 x ULN\n   * Alanine aminotransferase (ALT) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \\> 5.0 x ULN\n   * Aspartate aminotransferase (AST) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \\> 5.0 x ULN\n   * Absolute Neutrophil Count \\\u003C 1.0 x 109\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Platelet count \\\u003C 75 x 109\u002FL\n2. Unmanageable urinary tract obstruction or urinary incontinence. If ureteral obstruction can be managed with the placement of ureteral stents, this exclusion criterion does not apply.\n3. Known hypersensitivity to 68Ga-DFC413 or 68Ga-NNS309 or their excipients.\n4. Any serious uncontrolled infection (acute or chronic), such as, but not limited to, bacterial, viral or fungal infections, confirmed by clinical evidence, imaging, and\u002For relevant positive laboratory tests (e.g., blood cultures, PCR for DNA\u002FRNA). If a serious infection develops, it must resolve or be adequately controlled prior to 68Ga-DFC413 and\u002For 68Ga-NNS309 initiation.\n5. Surgery or major invasive procedure within 4 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n6. Radiation therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n7. Change in anticancer therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n8. Radiological contrast administration within 48 hours prior to 68Ga-DFC413 or 68Ga-NNS309 administration.\n9. Initiation or increasing doses of corticosteroids, TGF-β signaling inhibitors or immunomodulators within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n10. Known additional malignancy that is progressing or requires active treatment.\n11. Inability to complete the required investigational and standard imaging examinations due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time).\n12. Presence of CTCAE version 5.0 ≥ Grade 2 toxicity due to prior cancer therapy, except for neuropathy (inclusion of patients with neuropathy of ≤ Grade 2 is permitted) and alopecia.\n13. Any medical condition that would, in the Investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures (including radiation safety precautions), or interpretation of study results.\n14. Pregnant women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.\n15. Nursing (breast-feeding) women. Women who do not breast feed for 12 hours after 68Ga-DFC413 and\u002For 68Ga-NNS309 administration, but express and discard breast milk, are eligible.\n16. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they use highly effective methods of contraception (failure rate \\\u003C1% per year) for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309.\n\n    Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. hormonal profile confirming menopause and\u002For age-appropriate history of vasomotor symptoms).\n\n    Highly effective contraception methods include:\n    * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Bilateral tubal ligation, female sterilization (have had bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking 68Ga-DFC413 or 68Ga-NNS309. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.\n    * Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.\n    * Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example, hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n\n    If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent (IC).\n17. Sexually active males unwilling to use a condom during intercourse for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309. A condom is required for all sexually active male patients to prevent them from fathering a child and\u002For to prevent delivery of study treatment via seminal fluid to their partner. In addition, male patients must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the IC.\n\nOther protocol-defined inclusion\u002Fexclusioncriteria may apply.",{"count":375,"type":22},66,[25],"The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of \\[68Ga\\]Ga-DFC413, and in Part 2 compare to \\[68Ga\\]Ga-NNS309 in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+\u002FHER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC), colorectal cancer (CRC), and soft tissue sarcoma (STS). In Part 2 of this study (comparison of \\[68Ga\\]Ga-DFC413 and \\[68Ga\\]Ga-NNS309), not all indications might be explored.",[379,122,380,381,71,209,382],"Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","HR+\u002FHER2- Ductal Breast Cancer (BC)","HR+\u002FHER2- Lobular Breast Cancer (BC)","Soft Tissue Sarcoma (STS)",[384,385,386,387,388,389,390,391],"metastatic pancreatic ductal adenocarcinoma (PDAC)","non-small cell lung cancer (NSCLC)","HR+\u002FHER2- ductal breast cancer (BC)","HR+\u002FHER2- lobular breast cancer (BC)","triple negative breast cancer (TNBC)","colorectal cancer (CRC)","soft tissue sarcoma (STS)","radioligand imaging","2026-07-27",{"date":394,"type":41},"2026-07-28",{"date":396,"type":41},"2026-06-23",{"date":398,"type":22},"2028-01-16",{"name":400,"class":48},"Novartis Pharmaceuticals",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":176,"minAge":18,"maxAge":408,"enrollmentInfo":409,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":417,"leadSponsor":419,"locationsCount":49},"100649137","phase-3-a-study-of-bl-b01d1-plus-an-anti-pd-1-antibody-versus-nab-paclitaxel-plus-an-anti-pd-1-antibody-in-patients-with-previously-untreated-locally-advanced-inoperable-or-metastatic-triple-negative-breast-cancer-whose-tumors-express-pd-l1-panku-breast04-100649137","NCT07729956","A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)","A Phase III Randomized Controlled Clinical Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;\n2. Female patients aged 18 to 75 years;\n3. Expected survival time ≥ 3 months;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n5. Pathologically confirmed recurrent or metastatic triple-negative breast cancer;\n6. Confirmed PD-L1 expression positivity by central laboratory testing;\n7. No prior systemic anti-tumor therapy in the advanced\u002Frecurrent or metastatic setting;\n8. Agree to provide archived tumor tissue specimens (surgical specimens) or fresh tissue samples from primary or metastatic lesions obtained within 3 years;\n9. Must have at least one measurable lesion as defined by RECIST v1.1;\n10. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;\n11. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;\n12. Organ function levels must meet the protocol-specified requirements;\n13. Urine protein ≤ 1+ or \\\u003C 1000 mg\u002F24 h;\n14. For premenopausal women of childbearing potential, a pregnancy test (serum) must be performed within 7 days before starting treatment, and pregnancy must be ruled out; patients must not be lactating. All enrolled patients (regardless of sex) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Received surgery, radical radiotherapy, or immunotherapy within 4 weeks before the first dose;\n2. Prior exposure to ADC drugs with topoisomerase I inhibitor payload;\n3. Prior treatment with other T-cell receptor-targeting agents (excluding PD-1\u002FPD-L1);\n4. Use of immunomodulators within 14 days before the first study drug dose;\n5. History of severe cardiac or cerebrovascular disease;\n6. Receiving chronic systemic corticosteroids at \\>10 mg\u002Fday prednisone before the first dose;\n7. Active autoimmune or inflammatory disease;\n8. Any thrombotic event within 6 months before randomization;\n9. Prolonged QTc, complete left bundle branch block, or similar;\n10. Active malignancy diagnosed within 3 years before randomization;\n11. Hypertension uncontrolled by two antihypertensives;\n12. Poorly controlled diabetes\u002Fhyperglycemia;\n13. History of steroid-treated ILD\u002Finterstitial pneumonitis;\n14. Concurrent lung disease causing clinically significant respiratory impairment;\n15. Active CNS metastases;\n16. Severe infection within 4 weeks before randomization;\n17. Massive or symptomatic serosal effusion;\n18. Severe non-healing wound, ulcer, or fracture within 4 weeks before consent;\n19. Clinically significant bleeding or bleeding tendency within 4 weeks before consent;\n20. Inflammatory bowel disease, extensive bowel resection, immune enteritis, bowel obstruction, or chronic diarrhea;\n21. Allergy or contraindication to the study drug;\n22. History of autologous\u002Fallogeneic stem cell transplantation;\n23. HIV antibody positive, active HBV, or active HCV;\n24. History of severe neurological or psychiatric illness;\n25. Received or planning to receive live vaccine within 28 days before randomization;\n26. Other conditions rendering the patient unsuitable per investigator's judgment.","75 Years",{"count":410,"type":22},436,[181],"This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.",[29],"2026-07-22",{"date":394,"type":41},{"date":305,"type":22},{"date":418,"type":22},"2029-12",{"name":420,"class":48},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":339},"100562712","phase-3-personalizing-the-use-of-pembrolizumab-for-patients-who-have-a-strong-response-in-early-triple-negative-breast-cancer-100562712","NCT06606730","Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer","OPTimizing Adjuvant Prescription of PEMBROlizumab in Patients With Early-stage Triple-negative Breast Cancer Achieving Pathologic Complete Response After Standard Neoadjuvant Chemotherapy and Pembrolizumab","OPT-PEMBRO","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent prior to any trial-related procedures. When the patient is physically unable to give his written consent, a trusted person of his choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;\n2. Age ≥ 18 years;\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n4. Histologically documented stage II-III breast cancer according to the primary tumour-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator during radiologic assessment, clinical assessment or both;\n5. Estrogen receptor (ER) and Progesterone receptor (PR) ≤10%; HER2-negative as per ASCO\u002FCAP guidelines Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours are triple negative;\n6. Patients previously treated with neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles (All systemic chemotherapy must have been completed preoperatively);\n7. Absence of residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy (Residual ductal carcinoma in situ \\[DCIS\\] is allowed);\n8. Have had an adequately excised breast cancer (surgical removal of all clinically evident disease in the breast and lymph nodes) :\n\n   1. Breast surgery: patients must have undergone either breast-conserving surgery or total mastectomy with histologically negative margins for invasive tumour and DCIS. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.\n   2. Lymph node surgery: patients must have had sentinel lymph node biopsy (SLNB) and\u002For axillary lymph node dissection (ALND) to evaluate the pathologic nodal status;\n9. Patients that have received adequate locoregional radiation therapy or with planned adequate locoregional radiation therapy;\n10. Adequate organ and bone marrow functions. All screening lab tests should be performed within 28 days before randomisation;\n\n    1. Absolute Neutrophil Count (ANC) ≥ 1,000 \u002FµL\n    2. Platelets ≥ 100,000 \u002FµL\n    3. Hemoglobin ≥ 9 g\u002FdL\n    4. Creatinine clearance ≥ 30 mL\u002Fmin for subject with creatinine levels \\> 1.5 x institutional upper limit of normal (ULN)\n    5. Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN (Patients with Gilbert's disease with a total bilirubin ≤ 2.5 x ULN and direct bilirubin within normal limits are permitted)\n    6. Aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤ 2.5 x ULN\n11. Randomisation must take place no more than 12 weeks after breast surgery. Adjuvant radiotherapy is authorized. If given, as per investigator discretion it can be given concurrently with pembrolizumab;\n12. Patients must not be pregnant or nursing (for women of childbearing potential only, a negative serum pregnancy test must be obtained within 7 days of Cycle 1 Day 1);\n13. Women of childbearing potential and male patients must agree to use 1 effective form of contraception and up to 4 months after the last dose of study drugs;\n14. Patients should be able and willing to comply with study visits and procedures as per protocol;\n15. Patients must be affiliated to a Social Security System (or equivalent).\n\nExclusion Criteria:\n\n1. Radiological or clinical evidence of metastatic disease (stage IV) documented by imaging or clinical examination;\n2. Evidence of recurrent disease following preoperative therapy and surgery;\n3. Any prior history of (ipsi- or contralateral) invasive breast cancer;\n4. Patients with a prior or concurrent malignancy (other than invasive breast cancer) whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of the investigational regimen;\n5. Patients for whom pembrolizumab has been permanently discontinued during the neoadjuvant phase of treatment due to pembrolizumab-related AE;\n6. History of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any component of the product;\n7. Medical conditions that require chronic systemic steroids (\\> 10 mg prednisone or equivalent) or any other form of immunosuppressive medication in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment;\n8. Known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis;\n9. HIV-infected patients on effective anti-retroviral therapy with detectable viral load within 6 months prior to enrollment;\n10. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better;\n11. Patients unwilling or unable to comply with the medical follow-up required by the trial due to geographic, familial, social, or psychological reasons;\n12. Persons deprived of their liberty or under protective custody or guardianship;\n13. Participation in another therapeutic trial within the 30 days prior to randomisation.",{"count":430,"type":22},2454,[181],"OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study.\n\nThe main goal of this research is to determine if patients with triple-negative breast cancer, who experience a complete response after neoadjuvant treatment, have the same chance of avoiding cancer recurrence whether they stop pembrolizumab or continue taking it for an additional 6 months.\n\nThis research will also take into account patients tolerance to treatment and quality of life.",[434,71],"Breast Cancers",{"date":436,"type":41},"2026-07-23",{"date":438,"type":41},"2025-07-23",{"date":440,"type":22},"2039-06-01",{"name":442,"class":194},"UNICANCER",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":451,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":459,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":469,"leadSponsor":470,"locationsCount":49},"100645329","phase-1-tislelizumab-in-combination-with-bevacizumab-and-capecitabine-in-advanced-solid-tumors-with-evaluation-in-immunotherapy-resistant-and-central-nervous-system-disease-100645329","NCT07681297","Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease","Phase Ib\u002FII Study of Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease (TIBEC)","TIBEC","Inclusion Criteria:\n\nPatients are eligible for enrolment if they meet all applicable general inclusion criteria and, where relevant, the cohort-specific inclusion criteria.\n\n1. General Inclusion Criteria\n\n   * Age 21 years or older at the time of informed consent.\n   * Histologically or cytologically confirmed advanced or metastatic solid tumor.\n   * Patients must have received at least one prior line of standard systemic therapy for locally advanced\u002Funresectable or metastatic disease, OR be ineligible for, intolerant of, or have declined standard-of-care therapy, with the specific reason documented in the source records.\n   * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n   * Estimated life expectancy of at least 12 weeks.\n   * At least one evaluable (measurable or non-measurable) lesion as defined by RECIST version 1.1, unless otherwise specified for a disease-specific cohort.\n   * Recovery to Grade 1 or baseline from acute toxicities of prior anti-cancer therapy, except for alopecia, vitiligo, or other toxicities deemed not clinically significant by the investigator.\n   * Adequate organ and marrow function within 14 days prior to first dose of study treatment, defined as follows:\n\n     1. Absolute neutrophil count ≥1.5 × 10\\^9\u002FL\n     2. Platelet count ≥100 × 10\\^9\u002FL\n     3. Haemoglobin ≥9.0 g\u002FdL\n     4. Total bilirubin \\\u003C1.5 × upper limit of normal, except in patients with known Gilbert's syndrome, in whom total bilirubin up to 3.0 × upper limit of normal is permitted provided direct bilirubin is within normal limits\n     5. AST and ALT \\\u003C2.5 × upper limit of normal, or \\\u003C5 × upper limit of normal in the presence of liver metastases\n     6. Calculated creatinine clearance ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n     7. Urine protein dipstick \\\u003C2+, or if urine dipstick is 2+ or greater, 24-hour urine protein \\\u003C1 g per 24 hours\n   * Adequately controlled blood pressure (systolic \\\u003C150mmHg, diastolic \\\u003C100mmHg) with or without anti-hypertensive medication.\n   * Able to swallow and retain oral medication.\n   * Able to understand and willing to sign written informed consent.\n   * Willing and able to comply with study visits, treatment plan, laboratory tests, imaging, and other protocol-required procedures.\n   * Prior exposure to immune checkpoint inhibitors, anti-angiogenic therapy, or fluoropyrimidines is permitted, unless prohibited by cohort-specific criteria.\n2. TNBC Cohort Inclusion Criteria\n\n   * Histologically confirmed triple-negative breast cancer, defined as estrogen receptor \\\u003C1%, progesterone receptor \\\u003C1%, and HER2-negative according to current ASCO\u002FCAP guidelines.\n   * Metastatic or unresectable locally advanced disease not amenable to curative treatment.\n   * PD-L1-negative disease, defined as combined positive score (CPS) \\\u003C10 using an approved assay.\n   * Candidate for first-line systemic therapy for metastatic disease.\n   * Patients must have measurable or non-measurable but evaluable disease per RECIST v1.1.\n   * Patients without measurable disease may be enrolled provided they have unequivocal non-measurable disease that can be adequately assessed or disease status on serial radiologic evaluations, in the opinion of the investigator.\n   * Prior neoadjuvant or adjuvant chemotherapy is permitted.\n   * Prior immune checkpoint inhibitor therapy in the neoadjuvant or adjuvant setting is permitted, provided it was completed at least 12 months prior to start of study treatment.\n   * Prior capecitabine is permitted only in the adjuvant setting, provided it was completed at least 12 months prior to start of study treatment.\n   * Patients with prior CNS disease are eligible only if CNS disease is clinically controlled, defined as asymptomatic or minimally symptomatic, does not require corticosteroids and does not require ongoing CNS-directed therapy.\n3. CNS Cohort Inclusion Criteria\n\n   * Histologically or cytologically confirmed advanced solid tumor.\n   * Progressive brain metastases.\n   * At least one measurable CNS lesion.\n   * Leptomeningeal disease is allowed.\n   * Patients receiving corticosteroids for management of CNS disease or CNS-related symptoms are eligible provided the corticosteroid dose is stable or decreasing for at least 7 days prior to first dose of study treatment.\n   * Patients with driver mutations (e.g., EGFR-mutant or ALK-rearranged NSCLC, HER2+ metastatic breast cancer) must have received at least one prior line of matched systemic therapy, unless such therapy is contraindicated, not tolerated, unavailable, or the patient is otherwise unsuitable in the investigator's judgment.\n4. HR-Positive\u002FHER2-Negative Cohort Inclusion Criteria\n\n   * Histologically confirmed hormone receptor-positive (defined as ER\\>1% or PR\\>1%), HER2-negative metastatic or unresectable locally advanced breast cancer not amenable to curative treatment.\n   * Patients must have measurable or non-measurable but evaluable disease per RECIST v1.1.\n   * Patients without measurable disease may be enrolled provided they have unequivocal non-measurable disease that can be adequately assessed or disease status on serial radiologic evaluations, in the opinion of the investigator.\n   * Prior failure of at least one line of endocrine therapy in the advanced or metastatic setting, unless deemed endocrine-resistant in the opinion of the investigator.\n   * Up to one prior line of palliative chemotherapy is permitted.\n   * If prior capecitabine was given, it must not have been administered in the metastatic setting and must have been completed \\>12 months prior to study entry.\n   * Any CNS disease must be clinically controlled, defined as asymptomatic or minimally symptomatic, must not require corticosteroids, and must not require ongoing CNS-directed therapy.\n\nExclusion Criteria:\n\nPatients will be excluded if they meet any applicable general exclusion criterion or any relevant cohort-specific exclusion criterion.\n\n1. General Exclusion Criteria\n\n   * Treatment with an investigational agent within 14 days prior to first dose of study treatment.\n   * Known hypersensitivity or contraindication to tislelizumab, bevacizumab, capecitabine, fluoropyrimidines, or any excipients of the study drugs.\n   * Known clinically significant dihydropyrimidine dehydrogenase deficiency.\n   * Uncontrolled or clinically unstable CNS disease, including poor performance status attributable to CNS disease, ongoing requirement for escalating corticosteroids, uncontrolled seizures, or rapid neurologic deterioration.\n   * Clinically significant cardiovascular disease, including uncontrolled hypertension, unstable angina, clinically significant arrhythmia, myocardial infarction, or stroke that is of clinical concern in the opinion of the investigator.\n   * Significant bleeding risk or recent clinically significant hemorrhage.\n   * History of gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months prior to first dose, or other conditions conferring high risk in the opinion of the investigator.\n   * Non-healing wound, active ulcer, or untreated fracture.\n   * Active infection requiring systemic therapy.\n   * Active autoimmune disease requiring systemic immunosuppressive treatment within the past 2 years, with exceptions such as replacement therapy or other conditions judged unlikely to recur.\n   * Current use of systemic immunosuppressive medication, excluding physiologic corticosteroid replacement or other permitted low-dose steroids.\n   * Active pneumonitis or interstitial lung disease requiring treatment, or other clinically significant pulmonary condition that, in the opinion of the investigator, would increase the risk of study treatment.\n   * Other active malignancy requiring treatment or likely to interfere with assessment of study endpoints, in the opinion of the investigator.\n   * Pregnancy or breastfeeding.\n   * Any serious medical, psychiatric, or social condition that, in the opinion of the investigator, would compromise patient safety, interfere with study participation, or confound interpretation of study results.\n2. TNBC Cohort Exclusion Criteria\n\n   * Prior systemic therapy for metastatic TNBC.\n   * Prior capecitabine in the metastatic setting.\n   * Progressive CNS disease. Patients with progressive CNS disease should be enrolled into the CNS cohort instead.\n3. CNS Cohort Exclusion Criteria\n\n   * Severely symptomatic or clinically unstable CNS disease, including rapid neurologic deterioration, uncontrolled seizures, or requirement for rapidly escalating corticosteroids.\n   * CNS disease requiring immediate neurosurgical intervention or urgent radiation therapy, in the opinion of the investigator.\n   * Stereotactic radiosurgery (SRS) including gamma knife, within 7 days before the first dose of study treatment.\n   * Whole brain radiotherapy (WBRT) within 21 days before the first dose of study treatment.\n   * Use of checkpoint inhibitor, bevacizumab, and\u002For capecitabine within 6 months before the first dose of study treatment.\n4. HR-Positive\u002FHER2-Negative Cohort Exclusion Criteria\n\n   * More than one prior line of palliative chemotherapy.\n   * Progressive CNS disease. Patients with progressive CNS disease should be enrolled into the CNS cohort instead.","21 Years",{"count":453,"type":22},154,[25,26],"This study is designed to establish the safety of the combination of PD-1 inhibitor tislelizumab, an anti-angiogenic agent bevacizumab and a chemotherapeutic agent capecitabine, in a phase Ib setting and to evaluate preliminary efficacy in selected expansion cohorts, including PD-L1-negative metastatic triple negative breast cancer (TNBC) and patients with active CNS disease. A sequential approach to cohort expansion will allow further evaluation in hormone receptor positive (HR+), HER2 negative (HER2-) disease if a signal of activity is observed in PD-L1 negative TNBC.",[457,29,458,184],"Advanced Solid Tumor Cancer","CNS Disease",[460,461,462,184,463,464,29],"Tislelizumab","Bevacizumab","Capecitabine","Advanced Solid Tumour Cancer","CNS disease","2026-07-09",{"date":467,"type":41},"2026-07-10",{"date":305,"type":22},{"date":336,"type":22},{"name":471,"class":194},"National University Hospital, Singapore",{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":176,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":481,"phases":4,"briefSummary":482,"conditions":483,"keywords":485,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":49},"100636810","predicting-response-to-immunochemotherapy-in-early-triple-negative-breast-cancer-100636810","NCT07570524","Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer","PRIME-TNBC","Inclusion Criteria:\n\n* Female.\n* Age ≥ 18 years.\n* Histologically confirmed invasive triple-negative breast cancer (ER and PR \\\u003C 10% by IHC, HER2 0, 1+, or 2+ with negative SISH), stage II or III.\n* Eligible for neoadjuvant immunochemotherapy according to the Keynote-522 regimen.\n\nIndication for intra-tumoral clip placement.\n\n\\- Signed written informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Hematoma requiring Grade II analgesics after diagnostic biopsy.\n* Known coagulation disorders.\n* Adults under guardianship, curatorship, or legal protection, or deprived of liberty.\n* Not affiliated with a social security system.",{"count":480,"type":22},200,"OBSERVATIONAL","The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). The main questions it aims to answer are:\n\n* Can detailed immune profiling of the tumor and its microenvironment predict pathological complete response (pCR, RCB-0) versus partial\u002Fnon-response (RCB-I, II, III) to neoadjuvant immunochemotherapy?\n* Are there specific immune or molecular biomarkers (e.g., TILs, CD3\u002F8\u002F20, FoxP3, PDL1, transcriptomic signatures) associated with progression-free survival and overall survival in this population? Researchers will compare patients achieving pCR (RCB-0) to those with residual disease (RCB-I, II, III) to determine if immune and molecular profiles can discriminate responders from non-responders and guide personalized treatment strategies.",[484],"Triple-negative Breast Cancer (TNBC)",[486,487],"Biopsy","Residual Cancer Burden score",{"date":467,"type":41},{"date":490,"type":41},"2026-06-25",{"date":492,"type":22},"2036-06-25",{"name":494,"class":194},"Center Eugene Marquis",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":23,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":519},"100594490","phase-1-a-study-of-225acac-aky-1189-in-patients-with-solid-tumors-100594490","NCT07020117","A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors","NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologic or cytologic confirmation of locally advance or metastatic disease\n* Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1\n* ECOG Performance Status of 0 or 1\n* Adequate end-organ function\n* Ability to give informed consent and comply with study requirements\n* Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids\n* Documented disease progression on prior line of therapy for metastatic disease\n\nExclusion Criteria:\n\n* Prior treatment with a therapeutic radiopharmaceutical\n* Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin\n* Received an investigational agent within the previous 28days\n* Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment\n* Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity",{"count":58,"type":22},[25],"This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\\[225Ac\\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.",[506,71,507,508,509,510,511],"Urothelial Carcinoma Bladder","Hormone Receptor Positive Breast Adenocarcinoma","Non Small Cell Lung Cancer","Cervical Adenocarcinoma","Colorectal Adenocarcinoma","Head and Neck Cancer",{"date":467,"type":41},{"date":514,"type":41},"2025-08-22",{"date":516,"type":22},"2032-06",{"name":518,"class":48},"Aktis Oncology, Inc.",12,{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":535,"leadSponsor":537,"locationsCount":4},"100645995","phase-1-enhancing-icb-efficacy-through-il-1-inhibition-in-tnbc-100645995","NCT07698106","Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC","Rebooting Sensitivity to Checkpoint Blockade Therapy in Triple-Negative Breast Cancer With Isunakinra (RESETT- I)","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Newly diagnosed, locally advanced, previously untreated and centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines, and staging per current AJCC staging criteria for breast cancer as assessed by the investigator based on radiological and\u002For clinical assessment:\n\n   Clinical stage T1c\u002FN1-N2, T2-4\u002FN0-2\n3. Provides core needle biopsies consisting of at least 2 separate tumor cores from the primary tumor to the central laboratory\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Demonstrates adequate organ function\n6. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study\n\nExclusion Criteria:\n\n1. Male Gender\n2. Luminal A\u002FB and HER2 positive breast cancer\n3. Multifocal early breast cancer\n4. History of invasive malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer\n5. Received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months\n6. Has received prior therapy with an anti-PD1, anti-PDL1\u002F-PDL2 agent or with an agent directed to another co-inhibitory T-cell receptor\n7. Participated in an interventional clinical study with an investigational compound or device within 4 weeks of randomization for this study\n8. Pre-existing inflammatory arthritis\n9. Has received a live vaccine within 30 days of the first dose of study treatment\n10. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)\n11. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment\n12. Active or uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C\n13. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n14. Has an active infection requiring systemic therapy\n15. Has significant cardiovascular disease\n16. Is pregnant or breastfeeding, or expecting to conceive children within the duration of the study\n17. Has a known history of active tuberculosis (TB, Bacillus Tuberculosis)\n18. Platelets ≤ 100x109\u002FL. ANC ≤ 1.5 x109\u002FL. Hemoglobin ≤ 80 g\u002FL\n19. ECOG≥2\n20. History of stroke or intracranial hemorrhage within 6 months prior to enrollment\n21. Presence of moderate or severe renal function impairment (estimated creatinine clearance \\\u003C60 mL\u002Fmin\u002F1.73m2)\n22. Patients with mild, moderate, or severe hepatic impairment or inadequate liver function (total bilirubin \\> 23 umol\u002FL, serum albumin \\\u003C 35 g\u002FL, INR \\> 1.70)\n23. Known hypersensitivity to E-coli derived proteins, isunakinra or any component of the product",{"count":319,"type":22},[25,26],"This study is a phase I\u002FII open-label randomized clinical trial to examine whether administration of isunakinra (EBI-005), a modified recombinant IL1 receptor antagonist, can sensitize human TNBC to the PD1 inhibitor-pembrolizumab-based neoadjuvant chemotherapy (NAC\u002FP) by changing the tumor microenvironment (TME) via reducing the recruitment of immunosuppressive tumorassociated macrophages (TAMs) and increasing activated cytotoxic T-lymphocytes (CTLs).",[29],"2026-07-06",{"date":533,"type":41},"2026-07-13",{"date":305,"type":22},{"date":536,"type":22},"2034-08",{"name":538,"class":194},"University Health Network, Toronto",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":23,"phases":548,"briefSummary":549,"conditions":550,"keywords":553,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":83},"100595203","phase-1-a-study-with-nkt5097-for-adults-with-advancedmetastatic-solid-tumors-100595203","NCT07029399","A Study With NKT5097 for Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2\u002FCDK4 Dual Degrader NKT5097 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* Able to provide written informed consent\n* Advanced unresectable or metastatic solid tumor (Part 1, 2 \\& 3 only)\n* Advanced unresectable or metastatic HR+\u002FHER2- breast cancer (Part 4 \\& 5 only)\n* Refractory to or unable to tolerate existing therapies (Part 1, 2 \\& 4 only)\n* Measurable or evaluable disease (Part 1, 2, \\& 4 only).\n* Measurable disease (Part 3 \\& 5 only)\n* Eighteen years of age or older\n* ECOG status of 0 or 1\n* Adequate organ function\n* Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol\n* Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose\n* Able to swallow oral meds\n* Willing to provide tumor tissue\n\nExclusion Criteria:\n\n* Advanced solid tumor that is a candidate for curative treatment\n* History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage I or Stage II cancers currently in complete remission\n* Not recovered from the effects of prior anticancer therapy\n* Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease requiring treatment\n* History of uveitis, retinopathy, or other clinically significant retinal disease\n* Major surgery within 30 days of administration of first dose\n* Active uncontrolled infectious disease\n* Significant liver disease (Child Pugh class B or C)\n* Should not have received any prior selective investigational inhibitors or degraders (Part 5 only)",{"count":547,"type":22},361,[25],"The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced\u002Fmetastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include:\n\n* What is the recommended dose for expansion and\u002For Phase 2, for both monotherapy and in combination with ET\n* What medical issues\u002Fsymptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET",[236,71,551,552],"CCNE1 Amplified Advanced Solid Tumors","HR+ HER2- Breast Cancer",[554,555,158,324,556,557,558,559,560,561,562,563,564,565,566,567],"CCNE1","cyclin E1","estrogen receptor positive","HER2-","breast cancer","post CDK4\u002F6i","HER2 expression","Fulvestrant","Letrozole","endocrine therapy","refractory","endocrine resistant","endocrine sensitivity","metastatic",{"date":569,"type":41},"2026-06-26",{"date":571,"type":41},"2025-03-25",{"date":573,"type":22},"2027-12-31",{"name":575,"class":48},"NiKang Therapeutics, Inc.",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":176,"minAge":18,"maxAge":177,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":589,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":592,"completionDateStruct":593,"leadSponsor":594,"locationsCount":4},"100643891","phase-3-an-open-label-randomized-phase-iii-study-of-trastuzumab-rezetecan-with-or-without-bevacizumab-in-first-to-third-line-blis-subtype-tnbc-100643891","NCT07669610","An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab in First to Third Line BLIS Subtype TNBC","A Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab as First- to Third-Line Treatment for Basal-like Immune-suppressed Triple-Negative Breast Cancer","TRIBE","Inclusion Criteria:\n\n1. Female patients aged ≥18 years and ≤70 years;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;\n3. Life expectancy of at least 3 months;\n4. Histologically confirmed invasive triple-negative breast cancer (defined as breast cancer with estrogen receptor \\[ER\\], progesterone receptor \\[PR\\], and human epidermal growth factor receptor 2 \\[HER-2\\] all determined to be negative by pathological testing. Specifically: ER-negative: IHC \\\u003C1%; PR-negative: IHC \\\u003C1%; HER2-negative: IHC -\u002F+ or IHC ++ with FISH\u002FCISH negative. All specimens must be verified as the BLIS subtype of the Fudan quadruple molecular classification by the Precision Medicine Center\u002FDepartment of Pathology at the study's participating center);\n5. Tumor stage: recurrent or metastatic breast cancer; for locally recurrent disease, radical surgical resection must be confirmed by the investigator to be not feasible. Number of prior lines of therapy in the advanced setting ≤2;\n6. Patients must have at least one lesion (measurable and\u002For non-measurable) that has not been previously irradiated, can be accurately assessed at baseline by CT\u002FMRI, and can be repeatedly evaluated according to RECIST 1.1;\n7. Adequate major organ function, meeting the following criteria:\n\n   Hematological parameters: hemoglobin (HB) ≥90 g\u002FL (without blood transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count (PLT) ≥75×10⁹\u002FL;Biochemical parameters: total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; in the presence of liver metastases, ALT and AST ≤5×ULN; serum creatinine (Cr) ≤1×ULN, and calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula);\n8. No prior radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks before study initiation, and recovery from acute toxicities of prior treatment (if surgery was performed, the wound must be completely healed); no peripheral neuropathy or only grade I peripheral neurotoxicity;\n9. Female subjects of childbearing potential must agree to use a medically accepted contraceptive method during the study treatment period and for at least 3 months after the last dose of study drug;\n10. Subjects must voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria will be excluded from this study:\n\n  1. Known central nervous system (CNS) metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, contrast-enhanced CT or contrast-enhanced magnetic resonance imaging (MRI) must be performed within 28 days before the first dose to rule out CNS metastases;\n  2. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmias;\n  3. Persistent adverse events of Grade ≥1 resulting from prior treatment. Exceptions to this are alopecia or conditions that the investigator deems should not preclude enrollment. Such cases should be clearly documented in the investigator's notes;\n  4. Major surgery (excluding minor procedures such as placement of vascular access) within 3 weeks before the first cycle of study treatment;\n  5. Pregnant or lactating patients;\n  6. Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;\n  7. Presence of third-space fluid accumulation (e.g., massive pleural effusion or ascites) that cannot be controlled by drainage or other methods;\n  8. Participation in another anti-tumor drug clinical trial within 3 weeks before the first use of the study drug;\n  9. Long-term unhealed wounds or incompletely healed fractures;\n  10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or HBV DNA ≥500 IU\u002FmL, or chronic hepatitis with abnormal liver function;\n  11. History of allergic constitution, known allergy to any component of the study drug regimen, or history of allergy to other monoclonal antibodies;\n  12. History of gastrointestinal bleeding within the past 6 months, or clear evidence of a tendency for gastrointestinal bleeding, such as esophageal varices at risk of bleeding, active local ulcerative lesions, or fecal occult blood test ≥ (++). Patients with fecal occult blood test (+) should undergo gastroscopy;\n  13. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to study enrollment;\n  14. Urinalysis showing urine protein ≥ (++), or confirmed 24-hour urine protein quantification \\>1.0 g;\n  15. Hypertension that cannot be controlled to within normal range with antihypertensive medication (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg);\n  16. Prior use of anti-angiogenic agents or prior exposure to an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as the payload",{"count":585,"type":22},140,[181],"This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the BLIS subtype. A total of 140 patients are planned to be enrolled.",[184,71],[158],"2026-06-20",{"date":490,"type":41},{"date":189,"type":22},{"date":191,"type":22},{"name":193,"class":194},{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":609,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":4},"100637942","phase-1-oral-zn-telomir-monotherapy-in-patients-with-advanced-or-metastatic-triple-negative-breast-cancer-tnbc-100637942","NCT07581314","Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)","A First-in-Human (FIH), Phase I\u002FII, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of Zn-Telomir Administered Orally as Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n1. Clinically defined histologically or cytologically confirmed triple-negative breast cancer (TNBC)\n2. Locally advanced unresectable or metastatic disease\n3. Must have completed prior anticancer therapy discontinued for a least 28 days\n4. Disease progression after prior systemic therapy for advanced\u002Fmetastatic TNBC\n5. At least one measurable lesion (tumor)\n6. Age ≥18 years\n7. Life expectancy ≥12 weeks\n8. Agreement to use highly effective contraception during study and for 3 months after treatment\n9. Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n1. HER2-positive or hormone receptor-positive breast cancer\n2. Active leptomeningeal disease\n3. Uncontrolled, symptomatic CNS metastases\n4. Concurrent participation in another interventional clinical trial\n5. Clinically significant cardiovascular disease\n6. Uncontrolled infection requiring systemic therapy\n7. Known Human Immunodeficiency Virus (HIV) with detectable viral load \\>400 copies\u002FmL\n8. Active hepatitis B virus (HBV) infection or active hepatitis C virus (HCV)\n9. Significant Gastrointestinal (GI) disorders\n10. Active bleeding disorders or coagulopathy\n11. Pregnancy or breastfeeding",{"count":603,"type":22},76,[25,26],"This is a first-in-human, multicenter, open-label Phase I\u002FII study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of oral Zn-Telomir monotherapy in adults with advanced or metastatic triple-negative breast cancer. Phase I uses a modified 3+3 dose-escalation design to determine safety, tolerability, maximum tolerated dose, and recommended Phase II dose. Phase II uses a Simon two-stage expansion design at the recommended Phase II dose to evaluate preliminary antitumor activity, including objective response rate per Response Evaluation Criteria in Solid Tumors.",[29,607,608],"Advanced Triple-Negative Breast Cancer","Metastatic Triple-negative Breast Cancer",[610,611,324,612],"Triple-Negative Breast Cancer","Zn-Telomir","Metastatic Breast Cancer","2026-06-18",{"date":396,"type":41},{"date":616,"type":22},"2026-10",{"date":618,"type":22},"2027-11",{"name":620,"class":48},"Telomir Pharmaceuticals, Inc.",{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":23,"phases":630,"briefSummary":631,"conditions":632,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":647},"100557993","phase-1-study-of-xb010-in-subjects-with-solid-tumors-100557993","NCT06545331","Study of XB010 in Subjects With Solid Tumors","A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors","* Age 18 years or older on the day of consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n* Adequate organ and marrow function.\n* Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.\n\n  * The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.",{"count":629,"type":22},396,[25],"This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.",[633,634,635,636,637,71],"Locally Advanced or Metastatic Solid Tumors","Esophageal Squamous Cell Cancer","Head and Neck Squamous Cell Cancer","NSCLC (Non-small Cell Lung Cancer)","Hormone-receptor-positive Breast Cancer","2026-06-17",{"date":640,"type":41},"2026-06-22",{"date":642,"type":41},"2024-08-06",{"date":644,"type":22},"2027-10-20",{"name":646,"class":48},"Exelixis",20,{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":176,"minAge":18,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":481,"phases":4,"briefSummary":658,"conditions":659,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":4},"100644318","circulating-tumor-dna-dynamics-to-optimize-neoadjuvant-therapy-in-her2-positive-and-triple-negative-breast-cancer-100644318","NCT07662252","Circulating Tumor DNA Dynamics to Optimize Neoadjuvant Therapy in HER2-Positive and Triple-Negative Breast Cancer","Evaluation of Circulating Tumor DNA Dynamics for Treatment Optimization in Stage II-III HER2-Positive and Triple-Negative Breast Cancer Candidate to NAT","NEOSHED","Inclusion Criteria:\n\n* Patients with documented stage II-III HER2+ or TNBC and fit candidates for NAT. 2. In TNBC group, confirmed negative ER, PR and HER2 disease by local testing on primary disease specimen: tumor must be negative ER, PR, and HER2 defined by immunohistochemistry (IHC) according to the American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines for hormone receptor testing (Allison et al., 2020; Wolff et al., 2023). 3. In HER2+ group, Confirmed HER2+ disease by local testing on primary disease specimen: tumour must be HER2+ according to ASCO\u002FCAP 2023 guidelines for HER2 testing (Wolff et al., 2023). 4. Patients with measurable disease; Patients with multifocal or multicentric breast cancer with at least one tumor lesion ≥1.0 cm in the longest diameter by ultrasound (reference lesion) are also eligible if the two largest tumor lesions have been histologically confirmed in the clinical evaluation and meet pathological criteria for TNBC and HER2+. 5. No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. 6. Patients with breast cancer are eligible for surgery. 7. Eastern Cooperative Oncology Group (ECOG) performance status≤2.\n\nExclusion Criteria:\n\n* 1\\. Patients with bilateral invasive BC. 2. Patients with metastatic BC (local spread to axillary lymph nodes is permitted (cN1\\_cN2a).\n\n  3\\. Patients with inflammatory BC. 4. Patients with a known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis. 5. Patients with a history of invasive BC, ductal carcinoma in situ or lobular carcinoma in situ, and other malignancy within 5 years prior to screening. 6. Patients with a documented history of haemorrhagic diathesis, coagulopathy, or thromboembolism. 7. Patients with known allergy or hypersensitivity to any of the study drugs or any of their excipients. 8. Patients with history of non-compliance to medical regimens. 9. Patients refusing to perform liquid and tissue biopsy. 10. Patients unwilling to or unable to comply with the protocol. 11. Patients having had major surgery within 14 days prior to screening. 12. Pregnant or lactating females prior to treatment. 13. Patients should be excluded if they have a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).",{"count":657,"type":22},186,"The purpose of this non-interventional, observational study is to evaluate the clinical utility of circulating tumor DNA (ctDNA) utility-specifically how quickly tumor DNA disappears from the bloodstream (ctDNA clearance)-to help monitor and predict treatment responses in patients with breast cancer.\n\nThe study focuses on patients diagnosed with Stage II to III HER2-positive or Triple-Negative Breast Cancer (TNBC) who are scheduled to receive standard neoadjuvant therapy (systemic treatment administered before surgery). Because these breast cancer subtypes involve different standard treatment regimens, the study prospectively stratifies patients into three distinct treatment cohorts (Cohorts A, B, and C) to match routine clinical practice and align blood sampling with meaningful clinical milestones.",[184,71,660],"HER2 + Breast Cancer","2026-06-16",{"date":396,"type":41},{"date":664,"type":22},"2026-07",{"date":666,"type":22},"2029-06",{"name":668,"class":194},"Federico II University",{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":675,"eligibilityCriteria":676,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":677,"targetDuration":4,"studyType":23,"phases":679,"briefSummary":681,"conditions":682,"keywords":683,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":690,"completionDateStruct":691,"leadSponsor":693,"locationsCount":49},"100632409","a-nurse-led-coping-and-supportive-intervention-for-patients-with-triple-negative-breast-cancer-100632409","NCT07513311","A Nurse-Led, Coping and Supportive Intervention for Patients With Triple-Negative Breast Cancer","Pilot Feasibility Trial of a Nurse-Led, Coping and Supportive Intervention (RESTORE) for Patients With Triple-Negative Breast Cancer","RESTORE","Inclusion Criteria:\n\n* Diagnosis of stage 1-3 triple-negative breast cancer\n* Age ≥ to 18 years\n* Between one and 12 months post curative therapy\n* Reporting distress at least 4\u002F10 on a one-item screener\n* Ability to read and respond in English or Spanish\n\nExclusion Criteria:\n\n* Patients with stage 4 cancer\n* Patients with impaired cognition or serious mental illness that would preclude participation in study procedures",{"count":678,"type":22},75,[680],"NA","The purpose of this study is to explore the feasibility and acceptability of a nurse-led, coping, and supportive care intervention for patients with triple-negative breast cancer. The intervention aims to improve psychosocial outcomes in patients with triple-negative breast cancer (e.g., quality of life (QOL), anxiety, fear of cancer recurrence (FCR)).",[71],[158,684,685,686],"coping","supportive care","nurse-led intervention","2026-06-11",{"date":689,"type":41},"2026-06-15",{"date":334,"type":22},{"date":692,"type":22},"2028-07-31",{"name":694,"class":194},"Massachusetts General Hospital","Triple Negative Breast Cancer TNBC"]