[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"other-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:other-solid-tumors":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,92,117,151,173,199,222],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100630569","nci-childhood-cancer-data-initiative-ccdi-led-pediatric-adolescent-and-young-adult-rare-cancer-registry-for-very-rare-solid-tumors-100630569",false,"NCT07489378","NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors","* INCLUSION CRITERIA:\n* History of newly diagnosed (within 1 year of diagnosis) very rare solid tumor (defined as an estimated 2 incident cases per million per year).\n* Age \\>= 1 month and \\\u003C= 39 years at the time of diagnosis.\n* Participants must have established care with a local treating physician.\n* Ability of the participant, parent\u002Fguardian, or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Diagnosis of any of the following at any time:\n\n  * Ewing Sarcoma\n  * Osteosarcoma\n  * Rhabdomyosarcoma\n  * Diffuse midline glioma (H3K27 altered)\n  * Atypical teratoid rhabdoid tumor\n  * Pleuropulmonary blastoma\n  * Common adult cancers that occur in pediatric\u002FAYA populations (i.e., colorectal cancer, breast cancer)\n* The participant is unlikely to comply with the terms of the protocol.","ALL","1 Month","120 Years",{"count":19,"type":20},4000,"ESTIMATED","OBSERVATIONAL","Background:\n\nAll childhood cancers are rare, but some are called very rare. Very rare cancers are diagnosed in 2 or fewer out of 1 million people each year. Researchers want to gather data so they can learn more about these very rare cancers. They hope to use the data to develop future treatments.\n\nObjective:\n\nTo gather data for a registry of very rare cancers found in children, teens, and young adults.\n\nEligibility:\n\nPeople aged 1 month to 39 years newly diagnosed (within the past year) with a very rare cancer.\n\nDesign:\n\nParticipation will be by phone or email. No clinic visits are required.\n\nResearchers will look at the participant s medical records. They will ask for samples of tumor tissue that were already removed. They will use the samples for genetic testing. The results of these tests will be sent to the participant s own doctors.\n\nSome participants will be asked for saliva or cheek swab samples. They will receive a kit in the mail. They will spit into a tube or swab the inside of their cheek. They will mail the sample back to the lab.\n\nParticipants will fill out questionnaires once a year for 5 years. They will answer questions about:\n\nFamily history, such as other cancers in the family and their income, work, and education.\n\nDemographics, such as their gender, nationality, ethnicity, education, and work history.\n\nSymptoms and treatment for their cancer. This may include level of pain, and emotional and physical well-being.\n\nParticipants data will be added to a secure database for other researchers. Their data will be anonymous.",[24,25,26,27,28],"Very Rare Tumors","Very Rare Cancers","Other Solid Tumors","Solid Tumor","Pediatric Rare Tumors",[30,31,32,33,34],"Longitudinal Study","Registry","Patient Reported Outcomes","Family History","Molecular Characterization","RECRUITING","2026-08-20",{"date":38,"type":39},"2026-08-21","ACTUAL",{"date":41,"type":20},"2026-08-26",{"date":43,"type":20},"2037-04-01",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":70,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100506685","phase-1-a-study-of-nt-175-in-adult-participants-with-advanced-malignancies-that-are-positive-for-hla-a0201-and-the-tp53-r175h-mutation-100506685","NCT05877599","A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation","An Open-label, Phase 1, Multicentre Platform Study to Evaluate the Safety and Preliminary Anti-tumour Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Participants With Advanced Malignancies That Are Positive for the TP53 R175H Mutation","Key Inclusion Criteria (Module 1)\n\n* Subjects must be at least 18 years of age\n* Subject must be diagnosed with one of the histologies below:\n\n  * NSCLC\n  * Colorectal adenocarcinoma\n  * HNSCC\n  * Pancreatic adenocarcinoma\n  * Breast cancer\n  * Ovarian cancer\n  * Any other solid tumor\n* Tumors must harbor a TP53 R175H variant mutation and subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Subject has at least 1 measurable lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria (Module 1)\n\n* Any another primary malignancy within the 3 years prior to enrollment\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.\n\nKey Inclusion Criteria (Module 2 - hematological malignancies)\n\n* At least 18 years of age\n* Diagnosis of AML or MDS that allows for efficacy assessments\n* Confirmation of TP53 R175H variant mutation in cancer cells\n* Subject must be HLA-A\\*02:01 positive (at least 1 allele)\n* ECOG performance status of 0 to 1\n\nKey Exclusion Criteria (Module 2 - hematological malignancy)\n\n* Acute promyelocytic leukaemia or isolated extramedullary disease\n* Another primary malignancy within 2 years (with exceptions)\n* HSCT within 100 days or immunosuppression for GvHD within 4 weeks\n* History of CNS or other extramedullary leukaemic involvement unless a lumbar puncture is negative for leukemic cells\n* Prior stroke, ischemic attack, significant cardiac disease, heart failure\n* Prior adoptive modified cell therapy\n* Known to have Li-Fraumeni syndrome or is known to have relatives who are diagnosed with Li-Fraumeni syndrome.","18 Years",{"count":57,"type":20},45,"INTERVENTIONAL",[60],"PHASE1","Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies",[63,64,65,66,67,26,68,69],"Non-small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Colorectal Carcinoma","Pancreatic Adenocarcinoma","Breast Cancer","Ovarian Cancer","Myeloid Neoplasms (AML\u002FMDS)",[71,72,73,74,75,76,77,67,68,78,79,80],"Cell therapy","TP53","Solid tumors","Non-small cell lung cancer","Head and neck squamous cell carcinoma","Colorectal carcinoma","Pancreatic adenocarcinoma","AML","MDS","TCR","2026-08-05",{"date":83,"type":39},"2026-08-06",{"date":85,"type":39},"2023-07-12",{"date":87,"type":20},"2029-07-31",{"name":89,"class":90},"AstraZeneca","INDUSTRY",18,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":58,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100587276","phase-1-a-study-of-dxc008-in-patients-with-prostate-cancer-and-other-solid-tumors-100587276","NCT06926283","A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors","A Phase I, Open-Label, Multicenter, First-in-Human, Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles and Preliminary Efficacy of DXC008 in Patients With Prostate Cancer and Other Solid Tumors (Such as Ewing Sarcoma)","Inclusion Criteria:\n\n1. Those who voluntarily sign the ICF and follow the protocol requirements.\n2. Male or female.\n3. Age: ≥ 18 years and ≤ 75 years.\n4. Expected life expectancy ≥ 6 months.\n5. ECOG performance status score: 0-2.\n6. Patients with various solid tumors who have failed standard treatment, including but not limited to progressive mCRPC.\n7. Prostate Cancer： Serum testosterone level during screening and prior to the first dose of investigational product: ≤50 ng\u002FdL (≤1.73 nmol\u002FL).\n8. Prostate Cancer is divided into two cohorts： Cohort 1: At least one measurable lesion as defined by RECIST v1.1. Cohort 2: At least one metastatic lesion on CT\u002FMRI, or bone scan imaging at baseline.Patients are assigned to the appropriate cohort as assessed by the investigator; the study procedures in Cohort 1 and Cohort 2 may be performed in parallel and simultaneously，it is not necessary to wait until all procedures in either cohort have been completed before initiating procedures in the other cohort.Other solid tumors：At least one measurable lesion as defined by RECIST v1.1.\n9. Toxicities from prior antitumor therapy must have recovered to Grade ≤ 1 as defined in the NCI-CTCAE v5.0 (except alopecia), or Grade 2 as defined by NCI-CTCAE v5.0, except for toxicity not constituting a safety risk by investigator judgment (eg, Grade 2 peripheral neurotoxicity).\n10. Organ function of the subjects must meet the following requirements:\n\n    Hematology:\n    1. ANC ≥ 1.5 × 10\\^9\u002FL (prior use of G-CSF is allowed, but G-CSF use is not allowed within 7 days prior to the screening laboratory tests).\n    2. Platelet count ≥100×10\\^9\u002FL (platelet transfusion is not allowed within 7 days before the screening laboratory tests).\n    3. HGB ≥ 90 g\u002FL (RBC transfusion or recombinant human erythropoietin use is allowed; RBC transfusion is not allowed within 7 days prior to the screening laboratory tests).\n\n    Liver function:\n    1. Total bilirubin (TBIL) ≤1.5×ULN, except for subjects with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin ≤1.5×ULN).\n    2. AST and ALT ≤ 3.0 × ULN.For patients with liver metastases, both AST and ALT ≤5×ULN.\n\n    Renal function:\n\n    Ccr ≥ 60 mL\u002Fmin; or creatinine ≤ 1.5 × ULN; urinalysis results show protein urine ≤ 1 +. For subjects with urine protein ≥2+ in urinalysis during the screening period, a 24-hour urine protein quantification should be performed, and those with 24-hour urine protein quantification ≤1 g can be enrolled.\n\n    Coagulation function:\n    1. INR≤1.5.\n    2. APTT or PT ≤ 1.5 × ULN. LVEF≥50%.\n11. Subjects and their spouses agree to use effective instrumental or pharmacologic contraception (excluding safe period contraception) from the time of ICF signing until 6 months after the last dose of investigational product.\n\nExclusion Criteria:\n\n1. Within 14 days prior to the first dose: Have undergone plasmapheresis, treated with prednisone at \\> 10 mg\u002Fday for \\> 3 consecutive days or equivalent dose of systemic corticosteroids or equivalent anti-inflammatory medication (Those who have received short-term treatment with such medications for the prevention of contrast media allergy may be enrolled).\n2. Have received systemic antineoplastic therapy or investigational product treatment within 28 days or 5 half-lives (whichever is shorter) prior to the first dose, have received radiotherapy within 14 days prior to the first dose.\n3. Have received monoclonal antibody therapy for anti-tumor purposes within 30 days prior to the first dose.\n4. History of solid organ transplantation.\n5. Ewing sarcoma：Prior treatment with XXX-targeted therapy (in Phase Ia clinical study only) Other olid tumors：Prior treatment with XXX-targeted therapy or topoisomerase inhibitors (in Phase Ia clinical study only).\n6. Presence of meningeal or brain metastases.\n7. Evidence of cardiovascular risk, including any of the following:\n\n   1. QTcF interval ≥ 470 msec (QT interval must be corrected for heart rate using the Fridericia formula \\[QTcF\\]).\n   2. Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular (AV) block.\n   3. Within 6 months before screening, history of myocardial infarct, acute coronary syndrome (including unstable angina pectoris), coronary angioplasty or stent implantation, or bypass grafting.\n   4. Class III or IV heart failure - as defined by the New York Heart Association Functional Classification.\n   5. Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg.\n8. Have dyspnea or any current condition that needs continuous oxygen therapy, or current active pneumonia or interstitial lung diseases (except mild cases as judged by the investigator).\n9. History of other primary malignancies, except for the following: malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma and squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast.\n10. Have severe unhealed wound, ulceration or bone fracture, or have received major surgery within 28 days prior to administration or expected major surgery during the clinical study.\n11. Prior history of allergy to any component or excipient of DXC008.\n12. Active hepatitis B with HBV-DNA greater than central upper limit of normal or greater than 1000 copies\u002FmL, active hepatitis C (Hepatitis C virus antibody positive with HCV RNA greater than lower limit of detection value).\n13. Known to be seropositive for the HIV; have active syphilis (only patients with a positive syphilis antibody are eligible for enrollment in the study), possible presence of active tuberculosis (chest imaging within 3 months prior to the first dose indicates active tuberculosis infection).\n14. Patients with active bleeding within 30 days before screening, or, judged by the investigator, to be at risk of massive digestive tract hemorrhage, hemoptysis, etc.; or with hereditary bleeding tendency or coagulation disorder, or bleeding symptoms requiring other medical intervention.\n15. Have experienced serious arterial\u002Fvenous thrombosis events within 6 months prior to the first dose, such as cerebrovascular accident (including transient cerebral ischemic attack), deep venous thrombosis, pulmonary embolism.\n16. Female subjects with positive serum pregnancy test or who are breastfeeding.\n17. Those with active infection requiring drug intervention (CTCAE ≥ Grade 2) within 2 weeks prior to the first dose of study treatment, uncontrollable pleural effusion, ascites, pericardial effusion requiring repeated drainage.\n18. Have received vaccination with live attenuated vaccine within 28 days prior to the first dose or planned to receive such vaccination during the study period.\n19. Patients with other conditions judged by the investigator that may have adverse effect on the patient's participation in the study.","75 Years",{"count":101,"type":20},110,[60],"This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, MTD, DLT, RP2D, the PK characteristics, preliminary anti-tumor activity, the immunogenicity of DXC008 in patients with prostate cancer and other solid tumors such as Ewing sarcoma.",[105,26,106],"Prostate Cancer","Ewing Sarcoma","2026-07-03",{"date":109,"type":39},"2026-07-07",{"date":111,"type":39},"2025-05-15",{"date":113,"type":20},"2030-04",{"name":115,"class":90},"Hangzhou DAC Biotechnology Co., Ltd.",4,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":58,"phases":126,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100358462","phase-1-study-of-ide196-in-patients-with-solid-tumors-harboring-gnaq11-mutations-or-prkc-fusions-100358462","NCT03947385","Study of IDE196 in Patients With Solid Tumors Harboring GNAQ\u002F11 Mutations or PRKC Fusions","A Phase 1\u002F2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ\u002F11 Mutations or PRKC Fusions","Inclusion Criteria:\n\n* Patient must be ≥18 years of age and able to provide written informed consent\n* Diagnosis of the following:\n\n  o MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Metastatic disease may be treatment naïve or have progressed on or after most recent therapy. If the most recent therapy was an immune-oncology agent, PD must be confirmed.\n\n  \\- If a patient is treatment naïve and human leukocyte antigen (HLA)-A\\*02:01 positive\\*\\*\\*, documentation is required to provide rationale why treatment with tebentafusp is not the ideal firstline treatment approach or of the patient's intolerance to tebentafusp.\n\n  \\*\\*\\*To be enrolled in the HLA-A\\*02:01 positive cohort, HLA status must be documented by test results from a CAP\u002FCLIA-certified laboratory.\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group ≤1 and expected life expectancy of \\> 3 months\n* Adequate organ function at screening\n* Adequate contraceptive measures for non-sterilized male and female patients of childbearing potential\n\nCrizotinib Combination Additional Inclusion Criteria:\n\n* Prior chemotherapy other therapies as applicable or major surgeries must have been completed at least 4 weeks prior to initiation of crizotinib\n* Patients with preexisting peripheral neuropathy can be included if it is Grade 1 or lower, prior to initiation of crizotinib Biopsy-eligible patients\n* Accessible lesion(s) that permit a total of at least two biopsies without unacceptable risk of a significant procedural complication.\n\nExclusion Criteria:\n\n* Previous treatment with a PKC inhibitor\n* Known MSI-H\u002FdMMR tumors who have not previously received immune checkpoint inhibitors\n* Known symptomatic brain metastases\n* Adverse events from prior anti-cancer therapy that have not resolved\n* Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus\n* Active infection requiring ongoing therapy\n* Recent surgery or radiotherapy\n* Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect\n* Females who are pregnant or breastfeeding\n* Impaired cardiac function\n* Treatment with prohibited medications that cannot be discontinued prior to study entry\n* For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin\n\nCrizotinib Combination Additional Exclusion Criteria:\n\n* Prior therapy directly targeting ALK, MET, or ROS1\n* Spinal cord compression\n* History of pneumonitis or interstitial lung disease\n* History of syncope\n* History of thromboembolic or cerebrovascular events ≤12 weeks prior to first dose of study treatment\n\nPK Substudy (optional) with Pravastatin Additional Exclusion Criteria:\n\n* Taken any dose of statin or inhibitor of organic anion transporting polypeptide within 7 days prior to enrollment in the study and cannot refrain from them through C2D1\n* Taken drugs that interfere with the absorption, metabolism, or elimination of pravastatin\n* Any contraindication associated to the use of statins or hypersensitivity component of pravastatin\n* Active liver disease\n\nDDI Cocktail Substudy Additional Exclusion Criteria:\n\n* Treatment with bupropion, repaglinide, flurbiprofen, omeprazole, esomeprazole, midazolam, and dabigatran etexilate within 7 days prior to Cycle 1 Day -1.\n* Intake of vitamin supplements containing Vitamin B6 (pyridoxine), grapefruit\u002Fgrapefruit juice, or Seville orange juice within 7 days prior to Cycle 1 Day -1.\n* Intake of any strong or moderate inhibitor of CYP2B6, CYP2CI, CYP2C9, CYP2C10 and OAT3 is prohibited within 7 days or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.\n* Moderate and strong inhibitors of CYP2A4\u002F5 or P-gp are prohibited within 7 days, or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.\n* Intake of strong or moderate inducers of CYP3A4\u002F5, CYP2B6, CYP2C9, CYP2C19, or OAT3 is prohibited during 15 days, or 5 half-lives, whichever is longer, prior to Cycle 1 Day -1.",{"count":125,"type":20},336,[60,127],"PHASE2","This is a Phase 1\u002F2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ\u002F11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors.\n\nPhase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.\n\nPhase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.\n\nPhase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study.\n\nCrizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity.\n\nAs of Protocol Amendment 10, Phase 1, Phase 2 dose expansion in IDE196 monotherapy, and Phase 2 dose expansion of IDE196 in combination with binimetinib have been fully enrolled. There were no patients enrolled in the crizotinib monotherapy cohorts.",[130,131,132,26],"Metastatic Uveal Melanoma","Cutaneous Melanoma","Colorectal Cancer",[130,134,135,136,137,138,139,140],"Uveal Melanoma","Protein Kinase C","Ophthalmology","Ocular Oncology","Darovasertib","IDE196","Ocular Melanoma","2026-06-04",{"date":143,"type":39},"2026-06-08",{"date":145,"type":39},"2019-06-28",{"date":147,"type":20},"2027-06-15",{"name":149,"class":90},"IDEAYA Biosciences",15,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":99,"enrollmentInfo":158,"targetDuration":4,"studyType":58,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":47},"100487812","phase-1-phase-i-clinical-study-of-bl-m07d1-in-locally-advanced-or-metastatic-digestive-tract-tumors-and-other-solid-tumors-100487812","NCT05631964","Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Initial Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors","Inclusion Criteria:\n\n1. Sign informed consent voluntarily and follow protocol requirements.\n2. No gender limitation.\n3. Age: ≥18 years and ≤75 years (phase Ia); ≥18 years old (phase Ib).\n4. The expected survival time is ≥3 months.\n5. Patients with locally advanced or metastatic HER2-positive\u002Flow-expression digestive tract tumors and other solid tumors that are not operable and have been confirmed by histopathology and\u002For cytology, have failed standard therapy, are not available for standard therapy, or are not currently applicable for standard therapy; HER2 positive: IHC 3+, or IHC 2+ and ISH positive; Low HER2 expression: IHC 2+ and ISH negative, or IHC 1+.\n6. Agree to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesion within 2 years (to detect HER2 expression or amplification in tumor pathological tissue and explore its correlation with effectiveness indicators of BL-M07D1); If a subject is unable to provide a tumor tissue sample, he\u002Fshe may be enrolled after an investigator's evaluation if other admission criteria are met.\n7. There must be at least one measurable lesion that meets the RECIST v1.1 definition.\n8. ECOG score 0 or 1.\n9. The toxicity of previous antitumor therapy was restored to ≤1 as defined by NCI-CTCAE v5.0(except for asymptomatic laboratory abnormalities considered by the investigators, such as elevated ALP, hyperuricemia, and elevated blood glucose; Toxicities with no safety risk, such as hair loss, hyperpigmentation, grade 2 peripheral neurotoxicity, etc.).\n10. No serious cardiac abnormality, left ventricular ejection fraction ≥50%.\n11. The level of organ function must meet the following requirements and meet the following standards:\n\n    1. Bone marrow function: absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelet count ≥100×109\u002FL, hemoglobin ≥90 g\u002FL;\n    2. Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver metastasis;\n    3. Kidney function: Creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL\u002Fmin (based on Cockcroft and Gault formula).\n12. Coagulation function: International Standardized ratio (INR) ≤1.5, and activated partial thrombin time (APTT) ≤1.5ULN.\n13. Urine protein ≤2+ or ≤1000mg\u002F24h.\n14. Albumin ≥30 g\u002FL.\n15. A pregnancy test must be performed within 7 days of starting treatment for premenopausal women who are likely to have children, the serum\u002Furine pregnancy must be negative, and the pregnancy must be non-lactation; All enrolled patients (male or female) should take adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Antitumor therapy such as chemotherapy, biotherapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small-molecule tyrosine kinase inhibitors) within 4 weeks prior to initial administration or within 5 half-lives, whichever is shorter; Mitomycin and nitrosourea were administered within 6 weeks before the first administration. Oral fluorouracil drugs such as Tizio, capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration; Traditional Chinese medicines or proprietary Chinese medicines with anti-tumor indications should be administered within 2 weeks before the first administration.\n2. Previously received ADC drug therapy with camptothecin derivatives (topoisomerase I inhibitors) as toxins (Phase Ib only).\n3. History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥2 (CTCAE 5.0), New York Heart Society (NYHA) ≥2 heart failure, history of transmural myocardial infarction, unstable angina, etc.\n4. Prolonged QT interval (QTcF \\> 450 msec in men or 470 msec in women), complete left bundle branch block, and degree III atrioventricular block.\n5. Active autoimmune or inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis, other than type I diabetes, hypothyroidism that can be controlled by alternative therapy alone, skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis).\n6. Other malignancies developed within 3 years of enrollment, excluding:(1)radical cervical carcinoma in situ or non-melanoma skin cancer;(2)the second primary cancer that has been completely cured and no recurrence within 3 years;(3)The researchers believed that both primary cancers could benefit from this study;(4)The investigators have clearly ruled out which primary tumor source the metastases belong to.\n7. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within 6 months prior to screening; Thrombus formation associated with infusion set is excluded.\n8. The poorly controlled pericardial effusion, pleural effusion and abdominal effusion with clinical symptoms were not suitable for inclusion by the researchers.\n9. Hypertension poorly controlled by antihypertensive medications (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg).\n10. According to CTCAE v5.0, patients were defined as ≥3 lung disease, ≥2 radiation lung disease, present or history of interstitial lung disease (ILD).\n11. Patients who received lung radiation therapy within 6 months with total dose ≥30 Gy.\n12. Patients with active central nervous system metastases. But the researchers believe that patients with stable brain parenchymal metastases can be included. The definition of stability should meet the following four requirements:\n\n    1. Seizures-free status lasting \\> 12 weeks with or without antiepileptic medication;\n    2. No need for glucocorticoids;\n    3. Two consecutive MRI scans (scan interval at least 4 weeks) showed stable imaging status;\n    4. Asymptomatic patients stable for more than 1 month after treatment.\n13. Patients with a history of allergy to recombinant humanized antibodies or human and mouse chimeric antibodies or to any excipient component of BL-M07D1.\n14. Previous recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).\n15. In previous treatment with anthracyclines, the equivalent cumulative dose of doxorubicin was greater than 360 mg\u002Fm2.\n16. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number \\> lower limit of detection) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA \\> lower limit of detection).\n17. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.\n18. Had participated in another clinical trial within 4 weeks prior to the first dose (counting from the time of the last dose).\n19. A pregnant or nursing woman.\n20. Other conditions included in this clinical trial were not considered appropriate.",{"count":159,"type":20},26,[60],"Evaluation of BL-M07D1 for injection in Phase I clinical study of safety, tolerability, pharmacokinetic Characteristics, and initial efficacy in patients with locally advanced or metastatic digestive tract tumors and other solid tumors.",[163,26],"Locally Advanced or Metastatic Digestive Tract Tumors","2025-09-25",{"date":166,"type":39},"2025-09-26",{"date":168,"type":39},"2023-01-05",{"date":170,"type":20},"2027-12",{"name":172,"class":90},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":15,"minAge":180,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":58,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100518241","phase-1-chimeric-receptor-t-cells-with-trastuzumab-in-her2-advanced-breast-cancer-and-other-solid-tumors-100518241","NCT06027983","Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors","Phase IB Followed by Phase II Study of Trastuzumab Combined With Autologous Chimeric Receptor T Cells in HER2+ Advanced Breast Cancer and Other Solid Tumors","Inclusion Criteria:\n\nPatients may be included in the study only if they meet all of the following criteria:\n\n* Age ≥ 21 years.\n* Histologically confirmed diagnosis of HER2-positive cancer defined by immunohistochemistry (IHC) to be HER2 IHC3+ or HER2 IHC2+ and FISH positive. If immunohistochemistry is not available, FISH method is acceptable. The HER2 positivities by FISH is determined as FISH amplification ratio positive by institutional guidelines. Tumor subtype for each phase include :\n* Phase I: HER2-positive breast or gastric cancer or other treatment-refractory HER2-positive solid tumors\n* Phase II : HER2-positive breast carcinoma\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Has measurable or evaluable disease based on RECIST 1.1 criteria\n* Estimated life expectancy of at least 12 weeks.\n* Prior lines of therapy:\n* HER2-positive breast cancer - patient must have failed at least two lines of anti-HER2 based therapy for advanced\u002Fmetastatic cancer. Patients with documented relapse while receiving or within 6 months of completion of adjuvant or neoadjuvant trastuzumab for HER2-positive breast cancer will be considered as 1 prior line of therapy.\n* HER2-positive gastric cancer - patient must have failed at least one line of anti-HER2 based therapy.\n* Other refractory HER2-positive solid tumors (non-breast, non-gastric) - have no standard therapies or have failed or unable to tolerate standard therapies\n* Has recovered from acute toxicities from prior anti-cancer therapies\n* Left ventricular ejection fraction ≥50%\n* Adequate organ function including the following:\n\n  o Bone marrow: Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109\u002FL Platelets ≥ 100 x 109\u002FL Haemoglobin ≥ 8 x 109\u002FL\n\n  o Hepatic: Bilirubin ≤ 1.5 x upper limit of normal (ULN), ALT or AST≤ 2.5x ULN, (or ≤5 X with liver metastases)\n\n  o Renal: Creatinine ≤ 1.5x ULN\n* Signed informed consent from patient or legal representative.\n* Able to comply with study-related procedures.\n* Specific to cohorts 3, 4 and 5 : Patients who have a history of VTE are eligible if as long as they are receiving therapeutic\u002Fprophylactic doses of anticoagulation.\n\nExclusion Criteria:\n\nPatients will be excluded from the study for any of the following reasons:\n\n* Treatment within the last 30 days with any investigational drug.\n* Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.\n* Major surgery within 28 days of study drug administration.\n* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.\n* Pregnancy.\n* Breast feeding.\n* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.\n* Active bleeding disorder or bleeding site.\n* Non-healing wound.\n* Poorly controlled diabetes mellitus.\n* Second primary malignancy that is clinically detectable at the time of consideration for study enrolment.\n* Symptomatic brain metastasis.\n* History of significant neurological or mental disorder, including seizures or dementia,\n* History of autoimmune disease or use of gamma immunoglobulin\n* Unable to comply with study procedures","21 Years","99 Years",{"count":183,"type":20},36,[60,127],"This phase Ib study aims to assess the safety and feasibility of combination of chimeric receptor T cells with trastuzumab in patients with HER2+ solid tumors, with further expansion of study population in HER2+ metastatic breast cancer once safety has been established.",[187,26],"HER2+ Advanced Breast Cancer","NOT_YET_RECRUITING","2025-09-21",{"date":191,"type":39},"2025-09-23",{"date":193,"type":20},"2026-11-01",{"date":195,"type":20},"2027-12-31",{"name":197,"class":198},"National University Hospital, Singapore","OTHER",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":58,"phases":208,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":47},"100560468","early-phase-1-study-of-kras-neoantigen-mrna-vaccine-abo2102-in-patients-with-kras--mutated-solid-tumors-100560468","NCT06577532","Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors","A Clinical Study to Investigate Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of mRNA Nanoparticles Encoding KRAS Neoantigens (ABO2102) in Participants With KRAS-mutated Advanced Pancreatic Cancer And Other Solid Tumors","Inclusion Criteria:\n\n1. ≥18 years of age at time of informed consent.\n2. Participants with histologically and\u002F or cytologically confirmed advanced solid tumors (such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, etc.), whose disease has progressed or being intolerant to relevant treatments during or following at least one line of systemic treatment; patients in the second stage include those who have experienced disease progression or intolerance to previous systemic treatments, as well as those who have not received systemic therapy but are deemed by the investigator to potentially benefit from the study treatment based on a comprehensive clinical assessment.\n3. Harboring at least one of the targeted KRAS mutants.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0\\~2.\n5. Life expectancy of ≥12 weeks.\n6. Sufficient organ function.\n\nExclusion Criteria:\n\n1. Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix.\n2. Received KRAS cancer vaccine before.\n3. Immunosuppressants or other immunomodulatory drugs were required within 4 weeks before the first dose of study treatment. Physiological doses of systemic steroids or topical medications are allowed. Topical medications should not exceed the dose recommended in the package insert or have any systemic exposure signs; Or patients with other acquired or congenital immunodeficiency diseases, or a history of organ transplantation who need to use immunosuppressants or other immunomodulatory drugs.\n4. History of severe allergies or known allergies to any active or inactive component of the study drug(s).\n5. Uncontrolled systemic infection; active tuberculosis.\n6. Severe cardiovascular diseases.\n7. Has known symptomatic, untreated central nervous system metastases, or CNS metastases requiring continued treatment. Participants with asymptomatic brain metastases and who do not require treatment are eligible for enrolment.\n8. Have active autoimmune and inflammatory diseases.\n9. Have immediate hypersensitivity, a history of eczema or asthma uncontrolled by topical corticosteroids.\n10. Have other serious medical conditions\n11. A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.",{"count":207,"type":20},56,[209],"EARLY_PHASE1","The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer and other solid tumors. The trial includes dose escalation (Part I) and dose expansion(Part II) parts.",[212,26],"Pancreatic Neoplasms","2025-05-18",{"date":215,"type":39},"2025-05-21",{"date":217,"type":39},"2024-09-24",{"date":219,"type":20},"2027-08",{"name":221,"class":198},"Ruijin Hospital",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":58,"phases":232,"briefSummary":233,"conditions":234,"keywords":238,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":4},"100543606","phase-1-crte7a2-01-tcr-t-cells-for-hpv-16-positive-advanced-cancers-100543606","NCT06358053","CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers","A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of CRTE7A2-01 TCR-T Cells in HLA-A*02:01+ Subjects With HPV16 Positive Advanced Cervical, Anal, or Head and Neck Cancers and Other Solid Tumors","Inclusion Criteria:\n\n1\\. Age \\>18 years and 65 years. 2. Patients with advanced solid tumors (such as cervical cancer, head and neck tumors, anal cancer, and other malignancies) who have failed standard treatment confirmed by histology and\u002For cytology, or who are intolerant to such treatment, and for whom there is no effective therapy available after standard treatment failure are considered as end-stage patients. Specifically for:\n\n1. Cervical cancer: a) Patients who have previously failed at least second-line systemic therapy (including at least one platinum-based regimen or anti-angiogenic therapy) and have shown disease progression or intolerance confirmed by pathological or radiological examination during or after the most recent treatment course, and are not amenable to treatment with surgery or radiotherapy, with no standard treatment options currently available for recurrent or metastatic cervical cancer.\n2. Nasopharyngeal cancer: a) Patients who have previously failed at least third-line systemic therapy or are intolerant, not amenable to treatment with surgery or radiotherapy, with no standard treatment options currently available for recurrent or metastatic nasopharyngeal cancer; b) EB virus negative.\n3. Head and neck squamous cell carcinoma: a) Patients who have previously failed at least second-line systemic therapy or are intolerant, with no standard treatment options currently available for recurrent or metastatic head and neck squamous cell carcinoma (non-nasal).\n\n3\\. Confirmation of HPV16 positive and HLA-A\\*02:01 allele. 4. ECOG performance status of 0-1. 5. Estimated life expectancy ≥ 3 months. 6. Patients must have at least one measurable lesion defined by RECIST 1.1. 7. Female patients of childbearing age must undergo a serum pregnancy test within 7 days prior to study treatment and the results must be negative, and are willing to use a very effective and reliable method of contraception from screening through 6 months after the last dose of study treatment.\n\n8\\. The patient must be willing to sign the informed consent form and have a good anticipation of compliance with study procedure.\n\nExclusion Criteria:\n\n1. Patient received any genetically modified T cell therapy.\n2. Patient is being treated with T cell immunosuppressive agent （such as cyclophosphamide, FK506,tripterygium glycosides） or T cell immunoagonist.\n3. Patients received chemotherapy, targeted therapy, immunotherapy, or other investigational agents within 2 weeks and received radiotherapy within 4 weeks before apheresis.\n4. Patients have any organ system function impairment as defined below:\n\n   * leukocytes\\\u003C3.0 x 109\u002FL\n   * absolute neutrophil count \\>1.5 x 109\u002FL\n   * hemoglobin\\\u003C90g\u002FL\n   * platelets \\\u003C100 x 1010\u002FL\n   * lymphocytes\\\u003C0.5 x 109\u002FL\n   * percentage of lymphocytes\\\u003C15%\n   * creatinine\\>1.5×ULN or creatinine clearance \\\u003C50mL\u002Fmin\n   * total bilirubin\\>3×ULN; ALT\u002FAST\\>3×ULN (patients with liver metastasis,\\>5×ULN)\n   * INR\\>1.5×ULN; APTT\\>1.5×ULN\n   * SpO2≤90%\n\n6\\. Patinets has serious medical conditions, disorders, and \u002F or comorbidities, including, but are not limited to: severe heart disease, cerebrovascular disease, epileptic seizures, uncontrolled diabetes (CTCAE 5.0: FBG ≥ 2 grade), active infection, active digestive tract Ulcer, gastrointestinal bleeding, intestinal obstruction, pulmonary fibrosis, renal failure, respiratory failure.\n\n7\\. Patient has a severe cardiovascular disease with 6 months before screening, including, but are not limited to, myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, Heart failure NYHA grade Ⅲ or Ⅳ.\n\n8\\. Left Ventricular Ejection Fractions (LVEF) \\\u003C50%. 9. Patient has a known active brain metastases. 10. Patient has a known myelodysplastic syndrome (MDS) or lymphoma. 11. Patient has a known active autoimmune disease, including , but are not limited to, acquired or congenital immunodeficiency disease, allogeneic organ transplantation, autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease.\n\n12\\. Patient has a known active Hepatitis B or Hepatitis C. 13. Patient has a history of Human Immunodeficiency Virus (HIV) . 14. Patient has a history of syphilis. 15. Pregnant or lactating women. 16. Patient has a known active mental and neurological diseases. 17. The principal investigator judged that it is not suitable to participate in this clinical study.","65 Years",{"count":231,"type":20},24,[60],"A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A\\*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection.",[235,236,237,26],"Cervical Cancer","Anal Cancer","Head and Neck Cancers",[239,240,241,242,243,244,80],"HPV","E7","immunotherapy","T cell","Adoptive cell therapy","T cell receptor","2024-04-06",{"date":247,"type":39},"2024-04-10",{"date":249,"type":20},"2024-04-15",{"date":251,"type":20},"2028-04-30",{"name":253,"class":90},"Corregene Biotechnology Co., Ltd"]