[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-cancers":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,59,93,125,150,172,193],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100611245","phase-1-adcx-020-for-the-treatment-of-patients-with-locally-advanced-or-metastatic-cancers-100611245",false,"NCT07238075","ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers","A First-in-human, Multicenter Dose Escalation and Multiple Cohort Expansion Phase 1a\u002Fb Study to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ADCX-020 in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Male and female participants ≥ 18 years of age\n* Ph1a: Locally advanced or metastatic solid tumor relapsed or PD following local standard treatments, for which no standard treatment is available\n* Ph1b: Eligible patients should have only received prior lines of systemic therapy according to SoC in the advanced\u002Fmetastatic setting (not counting neoadjuvant\u002Fadjuvant treatment if completed \\>6 months prior to recurrence)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Radiologically measurable disease by RECIST v1.1\n* Mandatory adequate tumor tissue sample available\n* Must have recovered from all clinically relevant toxicities from previous cancer therapies (to at least Grade 1, except for alopecia)\n\nExclusion Criteria:\n\n* Known allergies\u002Fhypersensitivity\u002Fintolerance to or contraindication to exatecan, or any excipient\n* Phase 1b: Prior antibody drug conjugate exposure with a topoisomerase 1 inhibitor payload\n* Uncontrolled or significant cardiac disease including left ventricular ejection fraction (LVEF) \\\u003C50%, myocardial infarction or uncontrolled\u002Funstable angina\n* Has clinically active central nervous system (CNS) metastases\n* Has a history of lung fibrosis or non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Active corneal disease, or history of corneal disease within 12 months prior to enrollment\n* Other unacceptable abnormalities, medications or procedures as defined by protocol","ALL","18 Years",{"count":19,"type":20},290,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors. ADCX-020 is an investigational anticancer therapy called antibody drug conjugate.\n\nThis study is set up in multiple parts. In the first part of the study, participants receive increasing doses of ADCX-020. Then 2 or more doses will be assessed to identify the optimal dose. This optimal dose is subsequently evaluated for effect on different cancer types.",[26,27,28],"Advanced Malignancy","Advanced Solid Cancers","Metastatic Solid Tumors",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Antibody Drug Conjugate","Antineoplastic Agents","Monoclonal Antibodies","Neoplasms","Response Evaluation Criteria in Solid Tumors (RECIST)","Phase 1 clinical trial","Maximum Tolerated Dose","Open-Label Trials","Multicenter Study","Pharmacokinetics","Pharmacodynamics","Drug-Related Side Effects and Adverse Reactions","Dose-Response Relationship, Drug","Adults","Progression-Free Survival \u002F Overall Survival","Overall response rate","RECRUITING","2026-06-05",{"date":49,"type":50},"2026-06-08","ACTUAL",{"date":52,"type":50},"2026-02-23",{"date":54,"type":20},"2029-11-30",{"name":56,"class":57},"Adcytherix SAS","INDUSTRY",9,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100640853","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-antitumor-activity-of-inv-6452-in-adult-patients-with-hormone-receptor-positive-human-epidermal-growth-factor-receptor-2-negative-hrher2--advancedmetastatic-breast-cancer-or-locally-advancedmetastatic-solid-tumor-100640853","NCT07612891","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+\u002FHER2-) Advanced\u002FMetastatic Breast Cancer or Locally Advanced\u002FMetastatic Solid Tumor","A Phase 1 and Phase 2, First-in-Human, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+\u002FHER2-) Advanced\u002FMetastatic Breast Cancer or Locally Advanced\u002FMetastatic Solid Tumor","Inclusion Criteria:\n\n1. Written informed consent obtained.\n2. Adult patients aged ≥ 18 years.\n3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors, who have disease progression following standard-of-care therapy, are intolerant to standard treatment, or have no available standard treatment options (e.g., HR+\u002FHER2- breast cancer, Cyclin E1-overexpressing solid tumors and other solid tumors).\n4. Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy (Phase Ⅱ).\n5. Have RECIST 1.1-defined measurable lesions.\n6. Has a life expectancy of \\> 3 months.\n7. ECOG performance status 0-1.\n8. Adequate marrow, liver and kidney function.\n9. Meet the study's specified contraceptive requirements.\n\nExclusion Criteria:\n\n1. Have a second primary malignancy.\n2. Patients with primary CNS tumors or CNS metastases with prior local treatment failure.\n3. Have received any anti-tumor therapy or participated in other therapeutic clinical trial within 28 days prior to the first dose of study drug.\n4. Has undergone major surgery within 28 days prior to the first dose of study drug.\n5. Prior anti-tumor therapy-related toxicities have not recovered to protocol-specified grades.\n6. Diagnosed with immunodeficiency or received any form of immunosuppressive therapy within 7 days prior to the first dose.\n7. Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.\n8. Have protocol-defined clinically significant cardiovascular diseases.\n9. Prolonged QTcF interval.\n10. Have any medical conditions likely to impair digestion and absorption of the investigational product.\n11. Patients with poorly managed blood glucose levels and blood pressure.\n12. Clinically significant abnormal serum potassium or sodium as judged by the investigator.\n13. Have experienced a severe concurrent infection 14 days prior to the first dose of study drug.\n14. Confirmed infection with HIV, HBV or HCV.\n15. Are currently receiving any other investigation agent.\n16. Have received prior CDK2 inhibitors.\n17. Patients with known hypersensitivity to the study drug or any of its components.\n18. History of allogenic tissue or solid organ transplant.\n19. Are unwilling or unable to comply with procedures required in this protocol.\n20. Has other severe systemic diseases or for other reasons deemed ineligible for participation in this clinical trial by the investigator.",{"count":67,"type":20},201,[23,69],"PHASE2","This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+\u002FHER2-) advanced\u002Fmetastatic breast cancer or locally advanced\u002Fmetastatic solid tumor.",[72,27,73,74,75],"Breast Cancer (Locally Advanced or Metastatic)","Metastatic (Stage IV) Breast Cancer","Ovarian Cancer","Endometrial Cancer",[77,78,79,80,81,82],"breast cancer","locally advanced solid tumor","metastatic solid tumor","ovarian cancer","endometrial cancer","HR+\u002FHER2-","2026-05-27",{"date":85,"type":50},"2026-05-29",{"date":87,"type":50},"2025-07-04",{"date":89,"type":20},"2028-02-04",{"name":91,"class":57},"Shenzhen Ionova Life Sciences Co., Ltd.",1,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100607306","phase-1-a-clinical-trial-to-test-if-the-investigational-drug-bnt329-is-safe-and-potentially-beneficial-for-people-with-advanced-solid-tumors-known-to-express-the-tumor-marker-ca19-9-100607306","NCT07186842","A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9","First-in-human, Open-label, Multi-site, Phase I\u002FIIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT329 in Participants With Advanced Solid Tumors Known to Express CA19-9","Key Inclusion Criteria\n\nAll participants and parts:\n\n* Have an ECOG PS of 0 to 1\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), except for ovarian cancer where participants will be evaluated according to Gynecologic Cancer InterGroup criteria.\n* Have a life expectancy of ≥3 months in the opinion of the investigator.\n* Have adequate organ, coagulation, and hematologic function as defined in the protocol.\n\nParts A, B, and C:\n\n* Have a histologically confirmed advanced\u002Fmetastatic tumor type that is known to express CA19-9: PDAC, carcinoma of the bile ducts, invasive urothelial carcinoma of the bladder and urinary tract, colorectal adenocarcinoma, adenocarcinoma of the esophagogastric junction, endometrial carcinoma, and epithelial ovarian cancer (including adenocarcinoma of the fallopian tube and peritoneal epithelial cancer \\[except mesothelioma\\]).\n* Have no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator. Participants must have received all available standard therapies, including targeted therapies based on mutation status (per guidelines from the Food and Drug Administration, American Society of Clinical Oncology, European Society for Medical Oncology, or local guidelines used at the site), and failed at least first-line standard of care therapy prior to enrollment.\n\nPart D:\n\n* Have a histologically confirmed diagnosis of PDAC.\n* Have received at least one prior systemic treatment regimen for advanced\u002Fmetastatic disease. Participants who have progressed on \\\u003C6 months of (neo)adjuvant chemotherapy can be included in the study.\n* Have radiographic disease progression and no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator.\n\nKey Exclusion Criteria\n\nAll participants and parts:\n\n* Are enrolled in another investigational study or are subject to exclusion periods from another investigational study.\n* Have had an inadequate washout period for prior anticancer treatment prior to the first dose of investigational medicinal product (IMP) as defined in the protocol.\n* Have received systemic steroids (\\>10 mg\u002Fday of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks prior to the first dose of IMP. The following are exceptions to this criterion:\n\n  * Inhaled sprays, topical steroids, or local steroid injections (e.g., intra-articular injection).\n  * Systemic steroids at physiological doses as replacement therapy (e.g., physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency).\n  * Steroids as pre-medication for hypersensitivity reactions (e.g., computed tomography (CT) scan pre-medication).\n* Have received any live vaccine within 4 weeks prior to the first dose of IMP or intend to receive a live vaccine during the study.\n* Have brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anticonvulsants for at least 2 weeks prior to the first dose of IMP.\n* Have a history of (noninfectious) interstitial lung disease (ILD)\u002Fpneumonitis that requires steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Have active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal conditions that may cause bleeding or perforation in the opinion of the treating investigator.\n* Have an active infection that requires systemic therapy within 1 week prior to the first dose of IMP. Participants receiving prophylactic anti-infective therapy (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) may be eligible after discussion with the sponsor.\n* Have unresolved toxicities from previous anticancer therapy as defined in the protocol.\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria may apply.",{"count":101,"type":20},245,[23,69],"The main goal of this study is to evaluate the safety of BNT329 and to identify the best dose of BNT329. This will be done by measuring the number of side effects that participants experience and how severe they are.\n\nThe second goal of this study is to evaluate how well BNT329 works. This will be done by measuring the number of participants who respond to the treatment. The length of time where the tumor does not grow or spread will also be measured.\n\nThe study will also evaluate how BNT329 moves into, through, and out of the body and how the treatment affects the body.",[27],[106,107,108,109,110,111,112,113,114],"CA19-9","Anti-drug conjugate (ADC)","Pancreatic ductal adenocarcinoma","Bile duct cancer","Colorectal cancer","Gastroesophageal junction cancer","Endometrial cancer","Ovarian cancer","Invasive urothelial carcinoma of the bladder and urinary tract","2026-05-12",{"date":117,"type":50},"2026-05-13",{"date":119,"type":50},"2025-11-18",{"date":121,"type":20},"2030-05",{"name":123,"class":57},"BioNTech SE",10,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100615244","phase-2-phase-iiiii-trial-of-prl3-zumab-in-advanced-solid-tumor-patients-100615244","NCT07290088","Phase II\u002FIII Trial of PRL3-Zumab in Advanced Solid Tumor Patients","An Open Label, Multicenter, Safety and Efficacy Phase II\u002FIII Study of PRL3-Zumab in Solid Tumor Patients","PRL3-zumab","Inclusion Criteria:\n\n1. Men and women aged 18 - 75 years with solid tumors\n2. Willing to provide written informed consent for the study.\n3. Histopathological diagnosis and metastatic status cancer at study entry.\n4. Stage 1-3 patients with no more than 3 prior lines of treatment\n5. Life expectancy of more than 6 months (especially for Pancreatic cancer patients).\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n7. Patient should have recovered from toxicity of prior treatment regimen to Grade 1 level except for alopecia or peripheral neuropathy or fatigue as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.\n8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at study entry and must follow highly effective contraception\n9. Adequate organ and hematological function as evidenced by the following laboratory studies within 10 days of treatment:\n\n   * Absolute neutrophil count ≥ 1.0 x 109\u002FL.\n   * Platelet count ≥ 75 x 109\u002FL. Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL).\n   * Prothrombin time and activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range.\n   * Total bilirubin ≤ 1.5x ULN.\n   * Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN) (≤ 5 x ULN in the presence of liver metastases).\n   * For patients with hepatocellular carcinoma (HCC) Child Pugh score of ≤ B7.\n   * Creatinine \\\u003C 1.5x ULN.\n10. Measurable disease by iRECIST.\n11. No history of active hepatitis B or C infection.\n\nExclusion Criteria:\n\n1. Patient has known untreated or symptomatic central nervous system metastasis.\n2. Female patient is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 150 days (for pregnancy or conception) or 30 days (for breastfeeding) after the last dose of study treatment.\n3. Patient has known history of human immunodeficiency virus (HIV) infection (HIV-1 or HIV-2 antibodies).\n4. Patient is receiving systemic glucocorticoids (only if higher than 10 mg or equivalent of prednisolone daily) or other immunosuppressive treatment for autoimmune disease or any other medical condition.\n5. Patient has experienced a severe hypersensitivity reaction to another monoclonal antibody.\n6. Patient has received treatment with any systemic anti-cancer therapies within 3 weeks prior to starting study treatment.\n7. Patient has undergone radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study treatment.\n8. Patient is unable to provide informed consent.\n9. Patient has received a prior stem cell or bone marrow transplant.\n10. Patient with abnormal cachexia.\n11. Patient with distended abdomen from ascites.\n12. Patient is currently participating in a treatment study or has participated in a study of an investigational agent within 4 weeks prior to the anticipated first dose of study treatment in this study.","75 Years",{"count":135,"type":20},52,[69,137],"PHASE3","This is a Multi-Center, Phase II\u002FIII, open-label, single dose level (6 mg\u002Fkg) basket trial of PRL3-zumab monotherapy in solid cancer patients.\n\nThe study will consist of a Screening Period (Day - 14 to Day -1) for completion of all screening assessments before the first administration of study treatment, a Treatment Period during which visits will occur every 2-week (PK T1\u002F2 = 12 days ±2 days), once the decision to discontinue treatment for any reason, an End of Treatment (EOT) visit will be performed within 14 days ±4 days after last dose of study treatment. Safety Follow-up\u002FEOS visit will be performed 28 days ±2 days after last dose of study treatment and survival follow-up call will be performed every month up to 6 months after EOS visit.\n\nPRL3-zumab will be administered by intravenous (i.v.) infusion till patient meets discontinuation criteria (progressive disease, clinically or per iRECIST, intolerable toxicity or withdrawal of consent). One cycle of treatment will be 4-weeks (2 infusions, 12 days±2 days apart). Patients will undergo safety assessment including laboratory tests prior to each infusion. Efficacy will be assessed by iRECIST at baseline and every 4 doses after study treatment. QoL assessments will be performed at Screening and every 4 doses ±7 days during treatment. A patient will be discontinued from study treatment if the patient progress clinically or per iRECIST criteria, or for intolerable toxicity, or if the patient withdraws consent. An EOT visit will be performed within14 days ±4 days after last study treatment dose.",[27],"2026-04-14",{"date":142,"type":50},"2026-04-16",{"date":144,"type":50},"2023-01-09",{"date":146,"type":20},"2026-12",{"name":148,"class":57},"Intra-IMMUSG Pte Ltd",4,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":92},"100629477","early-phase-1-exploratory-clinical-study-of-targeted-activated-dc-and-car-t-therapy-in-advanced-solid-cancers-100629477","NCT07475182","Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Advanced Solid Cancers","Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Patients With Advanced Solid Cancers.","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 75 years, regardless of gender;\n2. Advanced solid tumors with clear pathological confirmation, including but not limited to gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, etc.; at least one measurable lesion meeting RECIST 1.1 criteria (according to RECIST 1.1, the longest diameter of a measurable lesion on spiral CT scan ≥ 10 mm, or the short diameter of a pathological lymph node ≥ 15 mm);\n3. Tumor tissue positive for Claudin 18.2, GCC, TROP2, or PSMA targets by immunohistochemistry (IHC) (expression intensity ≥ 2+; percentage of positive cells ≥ 40%);\n4. Meets the indications for PBMC collection and has no contraindications for cell collection;\n5. Failure of standard second-line treatment, or lack of a standard treatment regimen; or refusal to receive chemotherapy (with signed documentation);\n6. ECOG performance status: 0-1;\n7. Life expectancy: ≥ 3 months;\n8. Toxicities from prior chemotherapy or other anti-tumor therapies must have resolved after a washout period (except for residual alopecia), ensuring that all organ functions meet the inclusion criteria;\n9. Adequate organ function, including:\n\n   1. Adequate immune function: absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹\u002FL, absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL, monocyte count ≥ 0.1 × 10⁹\u002FL.\n   2. Adequate hematopoietic function: platelet count ≥ 75 × 10⁹\u002FL, hemoglobin ≥ 90 g\u002FL. Patients must not have received blood transfusions or treatments such as granulocyte colony-stimulating factor, thrombopoietin, or erythropoietin within 14 days prior to the blood count assessment.\n   3. Adequate liver function: total bilirubin (TBIL) \\\u003C 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5 × ULN.\n   4. Adequate renal function: creatinine (Cr) ≤ 1.5 × ULN.\n   5. Adequate coagulation function: prothrombin time (PT) or activated partial thromboplastin time (APTT) \\\u003C 1.5 × ULN, and international normalized ratio (INR) \\\u003C 1.5.\n10. Individuals of childbearing potential must agree to use effective contraception during the study;\n11. Ability to understand and willingness to sign a written informed consent form;\n12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Oncological emergencies requiring immediate intervention, such as malignant pericardial effusion or tamponade, superior vena cava syndrome, or spinal cord compression;\n2. Significant cardiovascular disease, including:\n\n   1. Documented major cardiovascular events within the past 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or prior angioplasty, stent implantation, or coronary artery bypass grafting;\n   2. Clinically significant QT interval prolongation (QTcF \\> 470 ms for women or QTcF \\> 450 ms for men);\n3. Clinically significant bleeding tendency or coagulation disorders (e.g., hemophilia);\n4. Active infection with HIV, syphilis, hepatitis B virus (HBV), or hepatitis C virus (HCV);\n5. History of involuntary commitment due to mental illness, or any psychiatric condition deemed by the investigator to make the patient unsuitable for the trial;\n6. Concurrent autoimmune diseases, or long-term use of immunosuppressants or systemic corticosteroids;\n7. Poor compliance, as assessed by the investigator;\n8. Prior treatment with any targeted CAR-T cell therapy within 3 months before this CAR-T infusion;\n9. Uncontrolled active bacterial or fungal infections;\n10. Any other condition that, in the opinion of the investigator, makes the patient ineligible for the study.",{"count":124,"type":20},[159],"EARLY_PHASE1","This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Targeted Activated DC combined with CAR-T therapy in patients with Advanced Solid Cancers.This combination therapy activates dendritic cells (DCs) to precisely target the tumor site, reshaping the tumor immune microenvironment, breaking down the immunosuppressive barrier, and allowing CAR-T cells to penetrate deeper into the tumor more efficiently, precisely and persistently killing cancer cells.",[27],"2026-03-11",{"date":164,"type":50},"2026-03-16",{"date":166,"type":50},"2025-12-06",{"date":168,"type":20},"2028-06-06",{"name":170,"class":171},"Hainan Cancer Hospital","OTHER",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":92},"100570662","phase-1-study-of-sc-102-in-patients-with-advanced-solid-tumors-100570662","NCT06710158","Study of SC-102 in Patients With Advanced Solid Tumors","Phase Ⅰ Study to Evaluate the Safety\u002FTolerability, Pharmacokinetics, and Efficacy of SC-102 in Subjects With Advanced or Metastatic Solid Tumors That Express EphA2","Inclusion Criteria:\n\n1. Subjects voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).\n2. Aged 18 to 75 years at the time of signature of the ICF, without gender limitation.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n4. Life expectancy of ≥ 3 months as assessed by the investigator.\n5. Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the study.\n6. Must be willing and able to comply with the protocol and study procedures.\n7. Acceptable renal, hepatic, hematologic, and coagulation functions.\n8. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n9. Metastatic recurrent histologically confirmed malignant solid tumors and exhausted all appropriate treatment options per local guidelines.\n10. Confirmation of EphA2 expression by the central laboratory prior to enrollment is not required for participants enrolled in the dose escalation study, but required for participants enrolled in the dose expansion study.\n\nExclusion Criteria:\n\n1. History of other malignancy(ies) within 3 years before signing the ICF, except for cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, papillary carcinoma of the thyroid gland, carcinoma in situ of the duct in situ, or other malignant tumors that have survived without disease for more than 5 years.\n2. Any anticancer treatment, including experimental treatments, within 4 weeks before the first dose of the study drug.\n3. Radiotherapy to \\>30% of the bone marrow or extensive radiotherapy within 4 weeks, or local radiotherapy (e.g., radiation therapy to the thoracic spine and ribs) within 7 days, prior to the first dose of the study drug.\n4. Uncontrolled central nervous system metastases.\n5. Preexisting treatment-related toxicity Grade ≥ 2 (except Grade 2 alopecia and hypothyroidism stable with hormone replacement therapy).\n6. Preexisting Grade ≥ 2 (as per CTCAE v5.0) sensory or motor neuropathy.\n7. Major surgery within 4 weeks prior to the first dose of the study drug.\n8. History of interstitial lung disease (ILD), preexisting ILD, or the suspected ILD that cannot be ruled out by imaging examination at screening.\n9. Preexisting serious dermatological diseases, or having experienced serious skin toxicities during the prior anti-cancer treatment (e.g., Stevens-Johnson syndrome, toxic Epidermal Necrolysis, etc.).\n10. Active infection requiring systemic therapy within 14 days prior to the first dose of the study drug.\n11. History of thromboembolic events and bleeding disorders ≤ 3 months (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE)) prior to the first dose of the study drug.\n12. Positive results of virus serology tests.\n13. History of serious cardiovascular and cerebrovascular diseases.\n14. Has received treatment within 2 weeks prior to the first dose of the study drug, or requires ongoing treatment with a medication that is a strong inhibitor or inducer of the cytochrome P450 3A4 (CYP3A4) enzymes.\n15. Known sensitivity to any of the ingredients of the investigational product.",{"count":180,"type":20},120,[23],"This study will evaluate the safety, PK profile, and anti-cancer efficacy of SC-102 in subjects with advanced solid tumors",[27],"2025-07-28",{"date":186,"type":50},"2025-07-29",{"date":188,"type":50},"2024-12-05",{"date":190,"type":20},"2027-06",{"name":192,"class":57},"Tianjin ConjuStar Biologics Co., Ltd.",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":92},"100600073","phase-1-a-phase-ia-ib-study-of-hs387-in-subjects-with-advanced-solid-tumors-100600073","NCT07092748","A Phase Ia\u002F Ib Study of HS387 in Subjects With Advanced Solid Tumors","A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HS387 in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:\n\n  1. Men or women ≥18 years old and ≤75 years old.\n  2. Subjects with advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.\n  3. Survival expectation is ≥ 3 months.\n  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n  5. Phase Ⅰa: Subjects with advanced solid tumors have at least one evaluable lesion according to RECIST 1.1. Phase Ⅰb: Subjects with advanced solid tumors have at least one measurable lesion according to RECIST 1.1.\n  6. Subjects with adequate organ function at the time of screening.\n  7. Serum pregnancy test (for female of childbearing potential) negative prior to first dosing of study treatment. Male and female subjects of childbearing potential must agree to use effective methods of contraception throughout the study and for 3 months after the last dose of the investigational product.\n\n     Exclusion Criteria:\n* Subjects will be excluded if they meet any of the following criteria:\n\n  1. Has received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration.\n  2. Has active infection.\n  3. Has meningeal metastases or symptomatic central nervous system (CNS) metastases.\n  4. Significant impairment of oral drug absorption.\n  5. Has interstitial lung disease.\n  6. Pregnant or lactating women.\n  7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n  8. Has a major surgical procedure within 4 weeks prior to the first administration.\n  9. Has a treatment history of KIF18A inhibitor.\n  10. In the opinion of the Investigator, there are other factors that the subject is unsuitable for participation in this clinical study.",{"count":201,"type":20},110,[23],"This is a Phase Ia\u002FIb, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HS387 in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib)",[27],"2025-07-22",{"date":207,"type":50},"2025-07-30",{"date":209,"type":50},"2025-07-15",{"date":211,"type":20},"2028-12-31",{"name":213,"class":57},"Zhejiang Hisun Pharmaceutical Co. Ltd."]