[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-or-metastatic-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-or-metastatic-solid-tumors":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,45,70,103,131,155,181,203,237,258,281,302,324,349,372,394,416,439,460],{"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":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100557993","phase-1-study-of-xb010-in-subjects-with-solid-tumors-100557993",false,"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.","ALL","18 Years",{"count":19,"type":20},396,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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.",[26,27,28,29,30,31],"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","Triple Negative Breast Cancer (TNBC)","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-22","ACTUAL",{"date":38,"type":36},"2024-08-06",{"date":40,"type":20},"2027-10-20",{"name":42,"class":43},"Exelixis","INDUSTRY",20,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100642954","phase-1-a-first-in-human-phase-i-study-to-evaluate-emb-15-in-patients-with-locally-advanced-or-metastatic-solid-tumors-100642954","NCT07607054","A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.","A First-in-Human, Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Activity of EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n\\- 1) Able to understand and willing to sign an ICF 2) Males or females with the age ≥ 18 years 3) Life expectancy \\> 3 months. 4) ECOG performance status 0 or 1 5) Patients must have histologically or cytologically confirmed locally advanced or metastatic solid tumors, without standard therapy.\n\n6\\) Patients must provide archived tumor samples collected within 1 year. 7) Adequate hematological and organ function.\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will not be enrolled:\n\n  1. Any prior ALPP\u002FALPG targeting therapy\n  2. Has received anticancer therapy, radiotherapy, or investigational drug within \\\u003C 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;\n  3. Active autoimmune disease or history of autoimmune disease\n  4. Concurrent malignancy \\\u003C 5 years prior to study entry\n  5. active infection\n  6. Severe or uncontrolled cardiovascular disease requiring treatment\n  7. Other severe medical conditions",{"count":53,"type":20},50,[23],"The primary purpose of this study is to evaluate safety and tolerability profile of EMB-15, identify the recommended Phase 2 dose(s) (RP2Ds) for EMB-15. Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and the anti-tumor activity of EMB-15 will also be assessed.",[26],[58,59],"Phase 1","EMB-15","2026-06-11",{"date":62,"type":36},"2026-06-15",{"date":64,"type":20},"2026-05-26",{"date":66,"type":20},"2029-10-30",{"name":68,"class":43},"Shanghai EpimAb Biotherapeutics Co., Ltd.",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100483897","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-of-enzelkitug-as-a-single-agent-and-in-combination-with-checkpoint-inhibitor-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100483897","NCT05581004","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase Ia\u002FIb, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Life expectancy of at least 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\n* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy\n* Tumor specimen availability\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and\u002For radiotherapy, within 3 weeks prior to initiation of study treatment\n* Active hepatitis B (HBV) or hepatitis C (HCV) or tuberculosis\n* Positive test for human immunodeficiency virus (HIV) infection\n* Acute or chronic active Epstein-Barr virus (EBV) infection at screening\n* Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusion\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Active or history of autoimmune disease\n* Prior allogeneic stem cell or organ transplantation",{"count":78,"type":20},450,[23],"This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.",[26,82,83,84,85,86,87,88,89,90,91,92],"NSCLC","HNSCC","Melanoma","TNBC","Esophageal Cancer","Gastric Cancer","Cervical Cancer","Colorectal Cancer","Urothelial Carcinoma","Clear Cell RCC","HCC","2026-06-05",{"date":95,"type":36},"2026-06-09",{"date":97,"type":36},"2022-10-20",{"date":99,"type":20},"2028-07-31",{"name":101,"class":43},"Genentech, Inc.",41,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":44},"100598066","phase-1-a-study-of-mrg007-arr-217-in-patients-with-advanced-solid-tumors-100598066","NCT07066657","A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors","An Open-Label, Multi-Center, Dose Escalation, Confirmation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of MRG007 (ARR-217) in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","1. Willing to sign the informed consent form and follow the requirements specified in the protocol.\n2. Life expectancy ≥ 3 months.\n3. Tumor specimen available for CDH17 testing, or agree to biopsy at baseline.\n4. Patients with histologically and cytologically confirmed advanced or metastatic solid tumor who have failed or intolerant to standard therapy, or without alternative standard therapy.\n5. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n6. The score of ECOG for performance status is 0 or 1.\n7. Organ functions and coagulation function must meet the basic requirements.\n8. Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.\n\nExclusion Criteria:\n\n1. Patients with more than one cancer.\n2. Received CDH17-targeting anti-tumor therapy; received other investigational product, systemic corticosteroids or surgery for major organs within 4 weeks prior to the first dose; received anti-tumor therapy within 3 weeks or within 5 half-lives prior to the first dose, whichever is shorter; received radiotherapy within 2 weeks prior to the first dose; received potent CYP3A4 inducers or inhibitors within 2 weeks prior to the first dose or 5 half-lives of investigational product, whichever is longer.\n3. ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment\n4. Symptomatic Central nervous system and\u002For meninges metastasis.\n5. History of severe cardiovascular diseases\n6. Cerebrovascular accident, pulmonary embolism, or deep venous thrombosis within 3 months prior to the first dose, implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis\n7. History of previous or combined interstitial pneumonia, current interstitial pneumonia, or suspected interstitial pneumonia that cannot be ruled out through imaging during screening, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary dysfunction, symptomatic bronchospasm, etc.\n8. Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion\n9. Infection of active hepatitis B, active hepatitis C, or HIV\n10. Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections requiring intravenous anti-infection therapy within 2 weeks prior to the first study treatment\n11. Known allergic reactions to any component of MRG007, or known Grade≥3 allergic reactions to other prior anti-CDH17 (including investigational) or other monoclonal antibody.\n12. Other situations that are not suitable to participate a clinical trial per investigator's judgement",{"count":111,"type":20},405,[23],"This is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.",[26,89,87,115],"Pancreatic Cancer",[117,118,119,120,121],"MRG007","Advanced or Metastatic Solid Tumors","CDH17","ARR-217","ADC","2026-06-02",{"date":124,"type":36},"2026-06-04",{"date":126,"type":36},"2025-07-25",{"date":128,"type":20},"2030-12",{"name":130,"class":43},"ArriVent BioPharma, Inc.",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":69},"100629063","phase-1-bc3195-in-combination-with-pembrolizumab-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100629063","NCT07469774","BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Provide written informed consent.\n2. Aged at least 18 years at the time of ICF signature.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to the first dose of study treatment.\n4. Life expectancy of ≥ 3 months based on the Investigator's assessment.\n5. Participants in Dose escalation part must meet the following criteria: Histologically or cytologically confirmed advanced\u002Fmetastatic solid tumor by pathology report and have received, or been intolerant to, all treatment known to confer clinical benefit, including but not limited to: NSCLC, BC, HNSCC, ESCC, EMC, UC, CRC, OC, and prostate cancer. The sponsor or designee must approve eligibility for malignancies other than those specifically mentioned above.\n6. Participants in Dose expansion part must meet one of the following criteria:\n\n   1. For NSCLC (cohort 1):\n\n      Participants have pathologically documented Stage IIIB, IIIC, or Stage IV NSCLC without actionable genomic alterations (AGA) based on the American Joint Committee on Cancer, Eighth Edition (Participants must have documented negative test results for EGFR and ALK genomic alterations and have no known genomic alterations in ROS1, NTRK, BRAF, MET exon 14 skipping, or RET) and meet one of the following criteria:\n      1. Locally advanced or metastatic NSCLC participants relapsed or refractory to at least 1 prior line of therapy including platinum-based chemotherapy in combination with or without anti-PD(L)1 antibody; OR\n      2. Locally advanced or metastatic NSCLC participants relapsed or refractory to at least 2 prior lines of therapy including anti-PD(L)1 antibody and platinum-based chemotherapy sequentially.\n   2. For TNBC (cohort 2):\n\n      Participants have histologically or cytologically confirmed TNBC per ASCO\u002FCAP criteria based on the most recent analyzed biopsy or other pathology specimen and meets the following criteria: Relapsed or refractory to 2 or more prior systemic regimens for unresectable, locally advanced or metastatic disease (-For prior therapy, 1 could be in the (neo)adjuvant setting, provided progression occurred during treatment or within 12 months after treatment discontinuation;-Received taxane(s) in any setting).\n   3. For HNSCC (cohort 3):\n\n      Participants have histologically or cytologically confirmed locally advanced or metastatic HNSCC and meet one of the following criteria:\n      1. Relapsed or refractory to at least 1 prior line of therapy including platinum-based chemotherapy with cetuximab, or platinum-based chemotherapy with or without anti-PD(L)1 antibody. OR\n      2. Disease progression while on or after at least 2 prior lines of therapy including anti-PD(L)1 antibody and platinum-based chemotherapy sequentially.\n   4. For Other solid tumors (cohort 4):\n\n      Participants with other solid tumors and meets the following criteria:\n      1. Histologically or cytologically confirmed locally advanced or metastatic solid tumors (e.g., ESCC, EMC, UC, CRC, OC, prostate cancer or tumors with observed efficacy signal during the dose escalation part).\n      2. Participants refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n7. Participants with at least one measurable lesion according to RECIST v1.1 as assessed by the local site investigator\u002Fradiology.\n8. Participants with adequate organ function.\n9. Agree to provide previously archived tumor tissue samples, or newly obtained biopsy of a previously unirradiated tumor lesion (optional for dose escalation part). Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Details pertaining to tumor tissue collection can be found in the Laboratory Manual.\n10. Males and females of child-bearing potential must agree to use effective contraception (e.g., oral contraceptives, intrauterine devices, abstinence, or barrier contraceptives combined with spermicides) from the time ICF signature until 6 months after the last dose. Females of childbearing potential include those who are premenopausal and those who are 2 years postmenopausal.\n\nExclusion Criteria:\n\n1. Has received prior systemic anticancer treatment, including investigational agents, within 5 half-lives or 4 weeks prior to the first dose of study treatment (whichever is shorter). Has received Traditional Chinese Medication within 7 days prior to study treatment.\n2. Participants who have received major surgery (defined as requiring general anesthesia and \\>24-hour inparticipant hospitalization) within 4 weeks prior to the first dose of study treatment. Participant must have recovered adequately from complications from the intervention prior to starting study treatment.\n3. Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis.\n\n   Note: Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n4. Has had an allogeneic tissue\u002Fsolid organ transplant.\n5. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.\n6. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study treatment.\n7. Has clinically uncontrolled pericardial effusion, pleural effusion, or ascites at screening.\n8. Has a history of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or has current pneumonitis \u002F interstitial lung disease.\n9. Active viral infection requiring systemic therapy during the screening period.\n10. Hypertension that cannot be well-controlled with medical treatment. Not well-controlled is defined as systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>95 mmHg (adjustment of hypertensive medication prior to study initiation is permitted, but the mean of the most recent three consecutive blood pressure records prior to study entry must be ≤150\u002F95 mmHg \\[with at least 2- minute interval between each measurement\\]).\n11. Cardiovascular disease of clinical significance: Including New York Heart Association \\[NYHA\\] Class II-IV, congestive heart failure, second-degree or higher heart block, myocardial infarction within the past 3 months, unstable arrhythmia or unstable angina, marked QT interval prolongation (12-lead ECG showing baseline-corrected QTc interval \\>480 ms), cerebral infarction within 3 months, or having received PTCA or CABG within 6 months.\n12. Participants with active or chronic corneal disorders, with other active ocular conditions requiring ongoing therapy or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.\n13. Participants with any active infection that requires systemic anti-infective therapy judged by the investigators.\n14. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n    Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n15. Grade 2 or higher peripheral neuropathy. Other toxicities caused by prior anti-tumor therapy has not recovered to ≤ grade 1 (per CTCAE 5.0) (except for alopecia, pigmentation, and other events judged by the Investigator to be tolerable) or the level specified by the inclusion\u002Fexclusion criteria in this study.\n\n    Note: Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.\n16. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.\n17. Known severe hypersensitivity or delayed hypersensitivity (≥Grade 3) reactions to the same class and\u002For any components of BC3195 or pembrolizumab.\n18. Participants who received strong CYP3A4 inhibitors or strong CYP3A4 inducers within 14 days, before the first dose of the study treatment (refer to Appendix 7 for a list of strong CYP3A4 inhibitors and inducers).\n19. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention, or planned to receive live or live-attenuated vaccine during the screening. Administration of killed vaccines are allowed.\n20. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n21. Pregnant or breastfeeding or planning to become pregnant; a positive blood pregnancy test within 7 days prior to the first dose of study treatment.\n22. Participants with poor compliance, who are unwilling to or unable to follow study procedures.\n23. Has received radiation therapy to the lung that is \\>30 Gy within 6 months of the first dose of study treatment for participants with NSCLC.",{"count":139,"type":20},111,[23,141],"PHASE2","This is a Phase 1\u002F2, open-label, dose escalation and expansion study to assess the safety, pharmacokinetics, and preliminary efficacy of BC3195 in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors.",[26],[145],"Solid Tumors","2026-05-25",{"date":148,"type":36},"2026-05-28",{"date":150,"type":36},"2026-03-31",{"date":152,"type":20},"2028-12-31",{"name":154,"class":43},"Biocity Biopharmaceutics Co., Ltd.",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100539742","phase-1-a-study-to-investigate-ans014004-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100539742","NCT06307795","A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Life expectancy ≥ 12 weeks\n* Measurable disease per RECIST v1.1\n* Adequate organ and marrow function as defined in the protocol\n* With a pathogenetic MET alteration or ROS1 alteration or NTRK alternation\n\nExclusion Criteria:\n\n* Active infection including tuberculosis and HBV, HCV or HIV\n* Known active or untreated CNS metastases\n* Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression\n* Participants with serious cardiovascular or cerebrovascular diseases",{"count":163,"type":20},63,[23],"This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.",[26],[168,169,170],"ROS1","NTRK","ROS1\u002FNTRK","2026-04-15",{"date":173,"type":36},"2026-04-17",{"date":175,"type":36},"2024-06-24",{"date":177,"type":20},"2027-10",{"name":179,"class":43},"Avistone Biotechnology Co., Ltd.",15,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":69},"100608500","phase-2-a-study-of-yl202-in-patients-with-advanced-solid-tumors-100608500","NCT07202364","A Study of YL202 in Patients With Advanced Solid Tumors","A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects must meet all the following criteria to be included in the study:\n\n  1. Subjects who are aware of relevant study information prior to the start of the study, and voluntarily sign and date on the informed consent form (ICF).\n  2. Subjects aged ≥18 years at the time of giving informed consent\n  3. Body mass index (BMI) within the range of 18 to 32 kg\u002Fm2.\n  4. Subjects with histologically or cytologically confirmed non-Sq NSCLC\u002FCRC\u002FCC or other advanced solid tumor, and had received 1-2 lines of systemic therapy in the advanced\u002Fmetastatic setting\n  5. There is at least one extracranial measurable lesion as the target lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n  6. Archived or fresh tumor tissue samples are available.\n  7. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n  8. The function of organs and bone marrow meets the requirements within 7 days prior to the first dose\n  9. Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product.\n  10. Expected survival ≥3 months.\n  11. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.\n\nExclusion criteria\n\n* Subjects who meet any of the following criteria should be excluded from the study:\n\n  1. Prior drug therapy targeting HER3\n  2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors).\n  3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.\n  4. The washout period from the previous anti-tumor therapy is insufficient prior to the first dose of the investigational product.\n  5. Patients who received major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of the investigational product or those who are expected to receive major surgery during the study.\n  6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.\n  7. Prior treatment with systemic steroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunosuppressive treatment within 2 weeks prior to the first dose of the investigational product.\n  8. Patients who received any live vaccine within 4 weeks prior to the first dose of the investigational product or those who plan to receive live vaccine during the study period.\n  9. Meningeal metastasis or cancerous meningitis.\n  10. Brain metastasis or spinal cord compression.\n  11. Patients with uncontrolled or clinically significant cardiovascular diseases.\n  12. Clinically significant complicated pulmonary disorders.\n  13. Medical history of hepatic encephalopathy within 6 months prior to the first dose.\n  14. Subjects with active or chronic corneal disorders, or other active eye disorders requiring continuous treatment, or any clinically significant corneal disorders that preclude adequate monitoring of drug-induced keratopathy.\n  15. Diagnosed with Gilbert's syndrome.\n  16. Significantly symptomatic or unstable pleural effusion, peritoneal effusion, and pericardial effusion, or those requiring repeated drainage.\n  17. Medical history of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose, or active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may cause hemorrhage or perforation in the opinion of the investigator.\n  18. Serious infection prior to the first dose (National Cancer Institute-Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] v5.0 grade ≥3),\n  19. Patients with severe coagulopathy or other diseases with evident risk of bleeding.\n  20. Patients with uncontrolled diabetes mellitus.\n  21. Human immunodeficiency virus (HIV) infection; positive syphilis antibody and a positive titer result.\n  22. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n  23. Medical history of any other primary malignancies within 5 years prior to the first dose of the investigational product, except fully resected non-melanoma skin cancer, cured in-situ disease, or other cured solid tumors.\n  24. Unresolved toxicity of previous anti-tumor therapy,\n  25. History of severe hypersensitivity to inactive ingredients in the drug substance (DS) and drug product (DP) or other monoclonal antibodies.\n  26. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days prior to the first dose.\n  27. Have any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the subject ability to sign the ICF, adversely affect the subject ability to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance\u002Falcohol abuse, in the opinion of the investigator.",{"count":189,"type":20},100,[141],"This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in selected patients with advanced solid tumors.",[193,89,88,26],"Non Small Cell Lung Cancer","2026-03-05",{"date":196,"type":36},"2026-03-09",{"date":198,"type":36},"2025-08-04",{"date":200,"type":20},"2027-02-28",{"name":202,"class":43},"MediLink Therapeutics (Suzhou) Co., Ltd.",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":4},"100627239","phase-2-a-single-arm-open-label-multicenter-phase-ibii-clinical-trial-of-cvl237-tablets-in-combination-with-serplulimab-injection-for-the-treatment-of-advanced-solid-tumors-with-pten-loss-or-low-expression-100627239","NCT07446049","A Single-arm, Open-label, Multicenter, Phase Ib\u002FII Clinical Trial of CVL237 Tablets in Combination With Serplulimab Injection for the Treatment of Advanced Solid Tumors With PTEN Loss or Low Expression","Inclusion Criteria:\n\n1. Aged 18 to 75 years (inclusive of both endpoints), regardless of gender；\n2. Patients with locally advanced or metastatic solid tumors (gastric cancer, endometrial cancer, cervical cancer, ovarian cancer, lung cancer, breast cancer, and other tumor types) confirmed by histology or cytology, and with PTEN loss or low expression. Patients who have experienced disease progression after standard treatment or have intolerable toxicities from prior therapies, or for whom no standard treatment is available, as determined by the investigator. For breast cancer participants, PTEN low expression is limited to those who have relapsed or metastasized after prior treatment with trastuzumab and\u002For CDK4\u002F6 inhibitors;\n3. PTEN loss or low expression confirmed by IHC staining. The definition of PTEN loss or low expression is referenced as follows: Using a dual-scoring method, score the percentage of positive cells: 0% = 0 points; 1-25% = 1 point; 26-50% = 2 points; 51-75% = 3 points; ≥76% = 4 points. Score the staining intensity: no staining = 0 points; light brownish-yellow = 1 point; brownish-yellow = 2 points; brown = 3 points. Add the scores from the two categories. A total score of 0-2 is classified as \"A,\" 3-6 as \"B,\" and ≥7 as \"C.\" \"A\" indicates negative expression and is defined as PTEN loss; \"B\" indicates PTEN positive with low expression; \"C\" indicates PTEN positive with high expression;\n4. ECOG Performance Status (PS) of 0-1;\n5. Life expectancy of ≥3 months;\n6. Presence of at least one measurable lesion according to RECIST v1.1 criteria;\n7. Sufficient bone marrow and organ function levels (no use of blood products and\u002For hematopoietic growth factors within 14 days prior to the start of study treatment):\n8. Fertile eligible study participants (both male and female) must agree to use a reliable method of contraception (hormonal or barrier methods or abstinence, etc.) with their partner during the trial and for at least 6 months after the last dose of study drug; Women of childbearing potential must not breastfeed. Women of childbearing potential must also have a negative pregnancy test prior to the first dose of study drug;\n9. Voluntarily participating in this clinical trial, understanding the study procedures, and being able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Surgery or Trauma: Undergone major organ surgery or experienced significant trauma within 4 weeks before the first administration of the study drug, or requires elective surgery during the trial period; undergone core needle biopsy or other minor surgeries (excluding central venous catheterization or port-a-cath implantation) within 7 days before the first dose;\n2. Insufficient Washout Period for Prior Anti-tumor Treatments;\n3. Inability to Swallow, Chronic Diarrhea, or Bowel Obstruction: Presence of factors that may affect the intake and absorption of the study drug;\n4. Unhealed Wounds or Interventions: Unhealed wounds, abdominal fistulas, gastrointestinal stent placement, or extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months before the first dose;\n5. Uncontrolled Effusions: Presence of uncontrolled pleural effusion, ascites, or pericardial effusion;\n6. Concurrent Use of Certain Medications: Currently using medications that are substrates of OATP1B1 and OATP1B3, CYP3A4\u002F5 substrates, moderate or strong CYP3A4\u002F5 inhibitors, or strong CYP3A4\u002F5 inducers, and cannot discontinue or switch to alternative treatments before starting the study treatment;\n7. Central Nervous System (CNS) Metastases or Meningitis: Participants with untreated or active CNS metastases (e.g., brain edema, requiring steroid intervention, or progressive brain metastases) and\u002For carcinomatous meningitis. However, participants with CNS metastases who have received adequate local treatment (surgery or radiotherapy) and have no progression on imaging at screening after completion of local treatment may be eligible. Participants must have stable neurological symptoms for at least 2 weeks before the first dose and not require corticosteroid treatment;\n8. History of Severe Allergic Reactions: Known history of severe allergic reactions to multiple medications;\n9. Immune-related Adverse Events (irAEs): Participants who experienced ≥ Grade 3 irAEs or ≥ Grade 2 immune-related myocarditis during prior immunotherapy are not eligible;\n10. Active or Potentially Recurrent Autoimmune Diseases: Participants with any active or history of autoimmune diseases that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis), except for clinically stable autoimmune thyroid disease or Type I diabetes;\n11. Systemic Corticosteroid or Immunosuppressive Therapy: Participants who received systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent) or other immunosuppressive agents within 14 days before the first dose of study drug. Exceptions include: Use of topical, ocular, intra-articular, nasal, or inhaled corticosteroids; Short-term (≤7 days) use of corticosteroids (≤10 mg prednisone equivalent) for prophylaxis or treatment of non-autoimmune allergic conditions (e.g., preventing contrast agent allergy);\n12. Interstitial Pneumonia or Severe Pulmonary Diseases: Known or suspected interstitial pneumonia; other severe pulmonary diseases significantly affecting respiratory function within 3 months before the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fbronchiolitis obliterans; non-infectious pulmonary inflammation requiring steroid treatment;\n13. Infectious Diseases: Positive HIV test; participants with active chronic hepatitis B or active hepatitis C. Carriers of hepatitis B virus, stable hepatitis B after treatment (HBV DNA copy number below the detection limit of the testing center or deemed stable by the investigator), and cured hepatitis C patients (HCV RNA test result below the detection limit of the testing center) may be eligible;\n14. Unresolved Adverse Events from Prior Anti-tumor Treatment: Adverse events from prior anti-tumor treatment that have not resolved to ≤ Grade 1 (CTCAE 5.0), except for alopecia or other toxicities deemed non-threatening by the investigator;\n15. Severe Infections: Severe infection within 4 weeks before starting study treatment, including but not limited to bacteremia; active infection within 2 weeks before starting treatment requiring intravenous antibiotics;\n16. Active Tuberculosis: History or CT evidence of active pulmonary tuberculosis within 1 year before enrollment;\n17. Serious Cardiovascular or Cerebrovascular Events: Acute coronary syndrome, congestive heart failure (NYHA functional class ≥ II), aortic dissection, cerebral hemorrhage, stroke, or deep vein thrombosis within 6 months before the first dose;\n18. Vaccination: Received live or attenuated vaccines within 30 days before the first dose of study drug, or planned to receive live or attenuated vaccines during the trial;\n19. Other Primary Malignancies: History of other primary malignancies within 5 years before the first dose, except for cured basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc;\n20. History of Allogeneic Organ or Hematopoietic Stem Cell Transplantation: Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplantation；\n21. Other Conditions Deemed Ineligible by the Investigator: Such as alcohol or drug abuse, history of significant neurological or psychiatric disorders (e.g., epilepsy, dementia), or poor compliance.","75 Years",{"count":211,"type":20},180,[141],"This is a single-arm, open-label, multicenter, Phase Ib\u002FII clinical trial of CVL237 tablets in combination with serplulimab injection for the treatment of advanced solid tumors with PTEN loss or low expression",[26,215],"PTEN Loss or Low Expression",[217,218,219,220,221,222,223,224,225,226],"CVL237","Patients with PTEN loss or low expression","Patients with locally advanced or metastatic solid tumors","gastric cancer","endometrial cancer","cervical cancer","ovarian cancer","lung cancer","breast cancer","other tumor types","NOT_YET_RECRUITING","2026-02-25",{"date":230,"type":36},"2026-03-03",{"date":232,"type":20},"2026-05-01",{"date":234,"type":20},"2028-04-08",{"name":236,"class":43},"Convalife (Shanghai) Co., Ltd.",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":21,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":227,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":69},"100617440","phase-2-phase-2-clinical-study-to-evaluate-the-efficacy-safety-tolerability-and-pharmacokinetics-of-gh21-capsules-combined-with-d-1553-tablets-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-with-the-krasg12c-mutation-100617440","NCT07318649","Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GH21 Capsules Combined With D-1553 Tablets in Subjects With Locally Advanced or Metastatic Solid Tumors With the KRASG12C Mutation","Inclusion Criteria:\n\n* 1)Patients or their legal representatives can understand and voluntarily sign a written informed consent form (before starting this study and any study procedures); 2)Age ≥ 18 years, male or female; 3)Cohort 1: Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer with KRASG12C mutation who have failed standard therapy or no standard therapy and have been treated with KRASG12C inhibitors; Cohort 2: Histologically or cytologically confirmed locally advanced or metastatic solid tumors (except non-small cell lung cancer) with KRASG12C mutation who have failed standard therapy or have no standard therapy and have been treated with KRASG12C inhibitors.\n\n  4)Patients must have at least one measurable lesion that meets the definition of RECISTv1.1 (tumor lesions located in previously irradiated areas or other locoregional treatment sites are generally not considered measurable unless there is definite progression of the lesion); 5)Expected survival ≥ 3 months; 6)ECOG performance score: 0-1; 7)Patients must have adequate organ function, defined as follows: Blood\n  * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL without granulocyte colony-stimulating factor support within 14 days;\n  * Platelets≥100×109\u002FL without thrombopoietin (TPO) and interleukin-11 (IL-11) transfusion within 14 days;\n  * Hemoglobin ≥ 90 g\u002FL without transfusion within 14 days and without erythropoietin (EPO); Renal\n  * Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 ml\u002Fmin calculated using the modified Cockcroft-Gault equation or eGFR ≥ 60 ml\u002Fmin estimated by the MDRD equation; Liver\n  * Albumin ≥ 3.0 g\u002FdL;\n  * Total bilirubin ≤ 1.5 × ULN; in case of liver metastasis, total bilirubin ≤ 2.5 × ULN;\n  * AST\u002FALT ≤ 2.5 × ULN; in case of liver metastasis, AST\u002FALT ≤ 5 × ULN; Coagulation\n  * International normalized ratio (INR) and prothrombin time (PT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy (INR \\\u003C 2.5 × ULN) and PT or PTT is within the therapeutic range of the intended use of anticoagulants;\n  * Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy (APTT \\\u003C 2.5 × ULN) and PT or PTT is within the therapeutic range of the intended use of anticoagulants.\n\n    8)Men of childbearing potential and women of childbearing potential must agree to practice reliable contraception (hormonal or barrier methods or abstinence) from signing of informed consent until 6 months after the last dose of study drug. Females of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of study drug.\n\nExclusion Criteria:\n\n* 1)Patients who have received chemotherapy, biological agents for anti-tumor therapy within 3 weeks before the first dose, radiotherapy, endocrine therapy and other anti-tumor drugs within 4 weeks before the first dose, except for the following:\n\n  * nitrosourea or mitomycin C within 6 weeks before the first use of study drugs;\n  * oral fluorouracil, small molecule targeted drugs and Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 5 half-lives or 2 weeks before the first use of study drugs (whichever is shorter);\n  * Local palliative radiotherapy within 2 weeks before the first use of study drugs; 2)Receiving other unmarketed investigational drugs or treatments within 5 half-lives or 4 weeks (whichever is shorter) before the first dose; 3)Patients who underwent major organ surgery (excluding needle biopsy) or had significant trauma within 4 weeks before the first dose, or required elective surgery during the trial; 4)Use of strong inhibitors or strong inducers of CYP3A4 or P-gp within 2 weeks or 5 half-lives before the first dose; 5)Previous treatment with other SHP2 inhibitors. 6)Evidence of the following cardiac diseases: acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose;\n  * Grade III-IV heart failure according to New York Heart Association functional classification at screening;\n  * left ventricular ejection fraction (LVEF)≤50% by echocardiography (ECHO) at screening;\n  * Fridericia-corrected QT interval (QTcF)≥450 ms (male) and≥470 ms (female) at screening;\n  * poorly controlled hypertension (systolic blood pressure≥160 mmHg and\u002For diastolic blood pressure≥100 mmHg) after drug therapy at screening; 7)Dysphagia or gastrointestinal diseases or other malabsorption conditions affecting drug absorption, such as intestinal obstruction, Crohn 's disease, ulcerative colitis, short bowel syndrome, gastric emptying disorder or severe gastrointestinal related toxicity before the first dose and not recovered to less than grade 2; or confirmed to have clinically significant or acute gastrointestinal diseases; 8)Uncontrolled pleural effusion, pericardial effusion or pleural effusion requiring repeated drainage (once a month or more frequently); 9)Patients with active brain metastases or with symptoms of active central nervous system metastases including headache, vomiting and vertigo are eligible only if all of the following criteria are met, and asymptomatic patients with CNS lesions treated or untreated are eligible: • Measurable lesions located outside the CNS as determined by RECISTv1.1;\n  * Stable brain metastases after treatment are defined as no evidence of disease progression or bleeding within 28 days before the start of treatment, and steroid hormones and other therapeutic agents are discontinued for at least 14 days before enrollment; 10)patients with interstitial pneumonia within 6 months before the first dose, or any evidence of clinically active interstitial lung disease; 11)Hyperarterial\u002Fvenous thrombotic events within 6 months before the first dose, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism; 12)Patients with a history of other malignant tumors (cured skin squamous cell carcinoma in situ, basal cell carcinoma and cervical carcinoma in situ that have not recurred for 5 years, unless the investigator believes that they can be enrolled; in the dose escalation stage, unless the investigator believes that they can be enrolled); 13)Patients who have a history of severe allergy, or have a history of allergy to test drugs\u002Fany excipients\u002Fcombination therapy drugs, or have a history of allergy to multiple drugs; 14)Hepatitis B virus infection (HBsAg positive and DNA copy number \\> 1000 IU\u002Fml); or hepatitis C virus infection (HCV antibody positive, HCV RNA \\> upper limit of normal); or human immunodeficiency virus infection (HIV antibody positive); 15)Active infection (≥ Grade 2) requiring anti-infective treatment or fever of unknown origin exceeding 38℃ within 28 days before the first dose; 16)autoimmune diseases in the active stage as judged by the investigator within 28 days prior to the first dose; 17)Any toxicity caused by previous anti-tumor treatment before the first dose has not recovered CTCAE 5.0 grade evaluation ≤ 1 (unless alopecia, grade 2 peripheral neuropathy and\u002For other adverse events ≤ grade 2 that do not pose a safety risk); 18)Pregnant or lactating women; 19)The investigator considers that there are any clinical or laboratory abnormalities or other reasons that make the subject unsuitable to participate in this clinical study.",{"count":244,"type":20},120,[141],"The study is divided into 2 cohorts, Cohort 1 is patients with KRASG12C mutated non-small cell lung cancer who have failed standard therapy or no standard therapy and have been treated with KRASG12C inhibitor; Cohort 2 is patients with KRASG12C mutated solid tumors (except non-small cell lung cancer) who have failed standard therapy or have no standard therapy and have been treated with KRASG12C inhibitor. Each cohort consists of two stages, and 10 subjects are planned to be enrolled in the first stage of each cohort. According to the preliminary efficacy and safety data, each party will discuss and decide whether to continue the second stage. Twenty to fifty subjects were planned to be enrolled in Stage II of each cohort. A total of 20-120 subjects were enrolled.\n\nScreened eligible subjects received GH21 in combination with D-1553 in 21-day cycles until the investigator considered the subject no longer benefiting, or the subject developed intolerable toxicity, or the subject withdrew consent, or the subject died, or was lost to follow-up, or received a new anticancer treatment, whichever came first.",[26],"2026-01-04",{"date":250,"type":36},"2026-01-06",{"date":252,"type":20},"2025-12-30",{"date":254,"type":20},"2027-06-30",{"name":256,"class":257},"Suzhou Genhouse Bio Co., Ltd.","OTHER",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":186,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":209,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":280},"100524358","phase-2-a-study-of-yl202-in-selected-patients-with-advanced-solid-tumors-100524358","NCT06107686","A Study of YL202 in Selected Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects who are aware of relevant trial information before the start of the trial, and voluntarily sign and date on the informed consent form (ICF).\n2. Subjects aged from 18-75 (inclusive) years.\n3. Histologically or cytologically confirmed at diagnosis of NSCLC\u002FBC\u002FHNSCC\u002Fother locally advanced or metastatic solid tumors including but not limited to colorectal cancer, HER2-positive gastric cancer, cervical cancer, ovarian cancer, etc..\n4. At least one extracranial measurable lesion according to RECIST 1.1.\n5. Archived or fresh tumor tissue samples can be provided.\n6. With Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n7. The function of organs and bone marrow meets the requirements within 7 days before the first dose.\n8. Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product.\n9. With expected survival ≥ 3 months.\n10. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.\n\nExclusion Criteria:\n\n1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates \\[ADCs\\]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).\n2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.\n3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.\n4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.\n5. Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.\n6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.\n7. Prior treatment with systemic steroids (prednisone \\> 10 mg\u002Fday or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.\n8. Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.\n9. With meningeal metastasis or cancerous meningitis.\n10. With brain metastasis or spinal cord compression.\n11. Patients with uncontrolled or clinically significant cardiovascular diseases.\n12. Clinically significant complicated pulmonary disorders.\n13. Patients diagnosed with Gilbert syndrome.\n14. Those with uncontrolled effusion in the third space requiring repeated drainage.\n15. With a medical history of gastrointestinal perforation and\u002For fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator.\n16. With serious infection before the first dose.\n17. With known human immunodeficiency virus (HIV) infection.\n18. With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n19. With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.\n20. Unrelieved toxicity of previous anti-tumor therapy.\n21. With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.\n22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.\n23. With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance\u002Falcohol abuse, in the opinion of the investigator.",{"count":265,"type":20},200,[141],"This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.",[82,269,83,26],"Breast Cancer",[271],"Antibody-drug conjugate","2025-11-20",{"date":274,"type":36},"2025-11-26",{"date":276,"type":36},"2023-12-15",{"date":278,"type":20},"2028-11",{"name":202,"class":43},82,{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":209,"enrollmentInfo":288,"targetDuration":4,"studyType":21,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":69},"100542972","phase-1-a-study-of-bl-m05d1-in-patients-with-locally-advanced-or-metastatic-solid-tumors-100542972","NCT06349811","A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Sign the informed consent form voluntarily and follow the protocol requirements;\n2. Gender is not limited;\n3. Age: ≥18 years old and ≤75 years old;\n4. Expected survival time ≥3 months;\n5. locally advanced or metastatic solid tumors confirmed by histopathology and\u002For cytology with failure or intolerance to standard treatment or no standard treatment at present;\n6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 3 years;\n7. At least one measurable lesion meeting the RECIST v1.1 definition was required;\n8. ECOG 0 or 1;\n9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;\n10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;\n11. No blood transfusion, no use of cell growth factors and\u002For platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;\n12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;\n13. Urinary protein ≤2+ or ≤1000mg\u002F24h;\n14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Chemotherapy, biological therapy, immunotherapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral fluorouracil or palliative radiotherapy within 2 weeks before the first dose; Chinese patent medicine within 2 weeks before the first administration;\n2. History of severe cardiovascular and cerebrovascular diseases;\n3. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;\n4. active autoimmune and inflammatory diseases;\n5. other malignant tumors diagnosed within 5 years before the first dose;\n6. Hypertension poorly controlled by two antihypertensive drugs;\n7. had a history of ILD or a suspicion of such disease on imaging during screening; The patient was diagnosed with grade ≥1 radiation pneumonitis according to the RTOG\u002FEORTC definition;\n8. Pulmonary disease defined as grade ≥2 according to CTCAE v5.0; Pulmonary diseases lead to clinically severe respiratory function impairment;\n9. patients with poor glycemic control;\n10. patients with active central nervous system metastases;\n11. Patients with massive or symptomatic effusions, or poorly controlled effusions;\n12. Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large blood vessels;\n13. had a history of pulmonary embolism or a thrombotic event requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;\n14. had a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or any of BL-M05D1 ingredients;\n15. prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n16. The cumulative dose of anthracyclines \\> 360 mg\u002Fm2 in previous (new) adjuvant therapy;\n17. human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;\n18. active infection requiring systemic therapy;\n19. had participated in another clinical trial within 4 weeks before the first dose;\n20. pregnant or lactating women;\n21. The investigator did not consider it appropriate to apply other criteria for participation in the trial.",{"count":289,"type":20},30,[23],"This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in patients with locally advanced or metastatic solid tumors.",[26],"2025-06-13",{"date":295,"type":36},"2025-06-15",{"date":297,"type":36},"2024-04-19",{"date":299,"type":20},"2026-05",{"name":301,"class":43},"Sichuan Baili Pharmaceutical Co., Ltd.",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":21,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":323},"100455020","phase-1-a-study-to-assess-the-safety-pharmacokinetics-pharmacodynamics-and-preliminary-efficacy-of-atg-037-monotherapy-and-combination-therapy-with-pembrolizumab-in-patients-with-advanced-solid-tumors-100455020","NCT05205109","A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors","A Phase I\u002FIb, Multi-center, Open-label, and Dose-finding Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG-037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.\n2. Aged at least 18 years as of the date of consent.\n3. Unresectable Stage III or Stage IV melanoma patients, who have had disease progression on or after at least one prior ICI containing treatment. Patients with mucosal and uveal melanoma types are to be excluded.\n4. There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n5. Estimated life expectancy of a minimum of 12 weeks.\n6. Subjects with acquired immune checkpoint inhibitors resistance (objective response or SD\\>6 months).\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.\n8. Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding.\n9. Male subjects should be willing to use barrier contraception, ie condoms, for the duration of the study and 180 days after the final dose of study treatment.\n10. Subjects should have adequate organ function.\n\nExclusion Criteria:\n\n1. Primary central nervous system disease, central nervous system metastatic disease, leptomeningeal disease, metastatic cord compression or carcinomatous meningitis.\n2. Prior exposure to a CD73 inhibitor\u002Fantibody or adenosine receptor inhibitor.\n3. Patients considered to have rapidly progressive disease (from the starting of prior line therapy to disease progression lasting no more than 90 days).\n4. Prior therapy with any chemotherapy, immunotherapy, anticancer agents or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body.\n5. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study treatment. Subject must have recovered from all radiation related toxicity, not requiring corticosteroids.\n6. Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.\n7. Except for alopecia, platinum-induced peripheral neurotoxicity (≤Grade 2). Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) Grade 1 at the time of ICF signature.\n8. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.\n9. Subjects receiving unstable or increasing doses of corticosteroids.\n10. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension defined as a blood pressure (BP) ≥160\u002F100 mmHg despite medical therapy, unstable or uncompensated respiratory and renal disease, active bleeding diseases, allogeneic stem cell transplantation, or any solid organ transplant, etc.",{"count":310,"type":20},98,[23],"This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors",[26],"2025-06-05",{"date":316,"type":36},"2025-06-09",{"date":318,"type":36},"2022-06-07",{"date":320,"type":20},"2028-02-28",{"name":322,"class":43},"Antengene Therapeutics Limited",7,{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":21,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":69},"100475609","phase-1-a-study-to-investigate-the-safety-pharmacokinetics-and-clinical-activity-of-ap203-in-patients-with-locally-advanced-or-metastatic-solid-tumors-and-expansion-to-selected-malignancies-100475609","NCT05473156","A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies","A Phase 1\u002F2, Open-label Study of the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies","APT-CUBE","* Dose escalation Phase and Dose expansion Phase Inclusion Criteria:\n\n  1. Written informed consent by the participants or the participant's legally authorized representative prior to screening.\n  2. Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study enrollment and an estimated life expectancy of at least 3 months.\n  3. Disease must have at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Tumor lesions situated in a previously irradiated area are not considered measurable unless there has been demonstrated progression in the lesion. Imaging tests outside the screening period are valid if performed not more than 2 weeks before consent signature and otherwise fulfil protocol criteria.\n  4. Participants with adequate organ function defined by the following:\n\n     Participants must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening:\n     1. Absolute neutrophil count ≥ 1.5 × 109 \u002FL.\n     2. Platelet count ≥ 100 × 109 \u002FL.\n     3. Hemoglobin ≥ 9 g\u002FdL.\n     4. Alanine aminotransferase and AST ≤ 2.5 × ULN or \\\u003C 5 × ULN if hepatic metastases present.\n     5. Serum total bilirubin ≤ 1.5 × ULN (or \\\u003C 3 × ULN for participants with Gilbert's syndrome).\n     6. Alkaline phosphatase ≤ 2.5 × ULN or \\\u003C 5 × ULN if bone metastases present.\n     7. Prothrombin time ≤ 1.5 × ULN.\n     8. International normalized ratio (INR) ≤ 2.0 or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 is acceptable for participants on a stable dose of anticoagulants.\n     9. Estimated creatinine clearance \\> 50 mL\u002Fmin according to the Cockcroft Gault formula\n  5. Participants with highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists.\n* Dose escalation Phase specific Inclusion Criterion:\n\n  1. Participants with histologically or cytologically proven locally unresectable advanced or metastatic solid tumors, which are refractory or intolerant to standard therapy or for which no standard therapy exists.\n* Dose expansion Phase specific Inclusion Criteria:\n\n  1. Participants who have histologically or cytologically confirmed diagnosis of relapsed or refractory, locally unresectable advanced or metastatic NSCLC, HNSCC, ESCC, who received at least one line of systemic treatment including anti-PD-1 or anti-PD-L1 therapy.\n  2. Only participants who have evaluable PD L1 expression results are eligible.\n  3. NSCLC cohort:\n\n     * Documented histologically or cytologically squamous or non-squamous stage IV NSCLC.\n     * Documented evidence of tumors expressing PD L1 (TPS ≥ 1%) for the determination of PD L1 expression in NSCLC.\n     * No sensitive epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) rearrangement.\n     * No known actionable genomic alterations of ROS1 rearrangement, BRAF V600E mutation, MET mutation, NTRK1\u002F2\u002F3 gene fusion, and\u002For RET rearrangement.\n  4. HNSCC cohort:\n\n     • Documented histologically or cytologically squamous cell carcinoma of the head and neck. Nasopharynx is excluded.\n\n     • Refractory or intolerant to platinum based chemotherapy or concurrent chemoradiation.\n     * PD L1 expression: Documented evidence of Combined Positive Score (CPS) ≥ 1 for PD L1.\n  5. ESCC cohort:\n\n     * Documented histologically or cytologically squamous carcinoma.\n     * PD L1 expression: Documented evidence of CPS ≥ 1 for PD L1.\n* Dose escalation Phase and Dose expansion Phase Exclusion Criteria:\n\n  1. Participants who have received concurrent antitumor treatment or investigational products within 28 days or 5 half lives, whichever is shorter before the start of study intervention (e.g., chemotherapy, radiotherapy \\[with the exception of palliative bone directed radiotherapy\\], immunotherapy, targeted therapy, hormonal therapy, or cytokine therapy except for erythropoietin).\n  2. Participants who had major surgery within 28 days before the start of study intervention (excluding prior diagnostic biopsy).\n  3. Participants who had continuance of toxicities due to prior antitumor agents that have not resolved to Grade ≤ 1 per NCI CTCAE version 5.0, except alopecia, \\\u003C Grade 2 sensory neuropathy.\n  4. Participants with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.\n  5. Participants with previous malignant disease other than the target malignancy to be investigated in this study within the last 2 years with the exception of resected basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast.\n  6. Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following:\n\n     a. Brain imaging at screening shows no evidence of interim progression, participant is clinically stable for at least 2 weeks and without evidence of new brain metastases.\n\n     b. Measurable disease outside the CNS. c. No ongoing requirement for corticosteroids as therapy for CNS disease; off steroids 2 weeks before the first dose of AP203; anticonvulsants at a stable dose are allowed.\n  7. Participants who received any organ transplantation including allogeneic stem cell transplantation.\n  8. Participants with significant acute or chronic infections including, among others:\n\n     o Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n\n     Note: An HIV serology test (including antigen and\u002For antibodies) will be conducted at baseline for the participants with unknown HIV status and participants with positive HIV test will be excluded.\n\n     o Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV deoxyribonucleic acid (DNA) \\> 500 IU\u002FmL (or \\> 2500 copies\u002FmL) at screening.\n\n     Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \\\u003C 500 IU\u002FmL or \\\u003C 2500 copies\u002FmL) can be enrolled. Participants with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Participants receiving antivirals at screening should have been treated for \\> 2 weeks before the first dose of AP203.\n\n     o Participants with active hepatitis C. Note: Participants with a negative hepatitis C virus (HCV) antibody test at screening or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening are eligible. The HCV RNA test will be performed only for participants testing positive for HCV antibody. Participants receiving antivirals at screening should have been treated for \\> 2 weeks before the first dose of AP203.\n  9. Participants with active or history of any autoimmune disease that may relapse (participants with diabetes Type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.\n  10. Participants with known severe hypersensitivity reactions to monoclonal antibodies.\n  11. Participants with pregnancy or lactation period. (Note: a negative pregnancy test is required for WOCBP.)\n  12. Participants with known alcohol or drug abuse.\n  13. Participants with clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to the first dose of AP203), myocardial infarction (\\\u003C 6 months prior to the first dose of AP203), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.\n  14. Participants with any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n  15. Participants with live vaccination within 28 days of the first dose of AP203 and while on study is prohibited.\n  16. Participants with all other significant diseases, in the opinion of the Investigator, might impair the participant's tolerance of the study intervention.\n* Dose expansion Phase specific Exclusion Criterion:\n\n  1. Participants who have received prior therapy with any PD-L1 x CD137 bispecific antibody.",{"count":333,"type":20},168,[23,141],"This is a multi-regional, multi center, open label, first in human (FIH), dose-escalation, and dose-expansion study of AP203 to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and antitumor activities of AP203 in adult patients with locally advanced or metastatic solid tumors.",[26,337,338,339],"Non Small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Esophageal Squamous Cell Carcinoma (ESCC)","2025-03-23",{"date":342,"type":36},"2025-03-26",{"date":344,"type":36},"2023-07-24",{"date":346,"type":20},"2027-12",{"name":348,"class":43},"AP Biosciences Inc.",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":21,"phases":358,"briefSummary":359,"conditions":360,"keywords":361,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"100534912","phase-1-ptt-936-alone-or-in-combination-in-patients-with-locally-advanced-or-metastatic-solid-tumors-100534912","NCT06244992","PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors","A Phase 1\u002F2a Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) Activator, Alone or in Combination With Anti-PD-1\u002FL1 in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily signed informed consent form (ICF).\n2. Ability and willingness to adhere to all study procedures.\n3. Male or female patients ≥ 18 years of age at the time of signing the ICF.\n4. Locally advanced unresectable or metastatic solid tumor confirmed by histology or cytology\n5. For Part A: On tumor imaging, as assessed by RECIST v1.1 and iRECIST, with measurable or unmeasurable disease. For Part B: On tumor imaging, as assessed by RECIST v1.1 and iRECIST, with at least one measurable disease.\n6. Life expectancy ≥ 3 months.\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1 for Part A and Part B.\n8. Adequate end-organ and hematopoietic function, defined based on the following laboratory results obtained within 7 days prior to the first dose of study treatment \\[Day 1\\]):\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL (1500\u002FμL), without granulocyte colony-stimulating factor (G-CSF) support. Note that G-CSF may be administered until 14 days prior to Cycle 1 Day 1 (C1D1).\n   2. Platelet count ≥ 90×109\u002FL (90,000\u002FμL) without transfusion within 14 days prior to C1D1.\n   3. Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL). Note that patients may be transfused or receive erythropoietic treatment to meet this criterion until 14 days prior to C1D1.\n   4. Creatinine clearance ≥ 60 mL\u002Fmin.\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x the upper limit of normal (ULN) with or without primary or metastatic liver tumor lesions.\n   6. Total bilirubin (TBIL) ≤ 1.5 x ULN.\n   7. For patients not receiving therapeutic anticoagulation: International Normalized Ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT) ≤ 1.5 x ULN.\n   8. For patients receiving warfarin: INR ≤ 3.0 x ULN and no bleeding within 14 days prior to Day 1. Patients receiving therapeutic anticoagulation must be on a stable dose for a minimum of 14 days prior to Day 1. Patients on low molecular weight heparin will be allowed.\n\nExclusion Criteria:\n\n1. Patients with leptomeningeal (LMD) metastases or patients with new and\u002For progressive brain metastases at the time of study entry. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after central nervous system (CNS)-directed treatment (radiotherapy and\u002For surgery), as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.\n2. History of primary malignancy other than the diseases under study, not in remission greater than three (3) years prior to Day 1. Exceptions that do not require a 3-year remission include: adequately treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Papanicolaou (PAP) smear, in situ prostate cancer (with no evidence of active disease for two \\[2\\] years prior to Day 1), or resected melanoma in situ and radically resected papillary thyroid carcinoma.\n3. Persistence of Adverse Events (AEs) from prior anti-cancer therapy that have not resolved to Grade 1 (except for alopecia and hypothyroidism), or any history of Grade ≥ 3 immune-related adverse events (irAEs), Grade ≥ 2 pneumonitis, hypophysitis or encephalitis related to immunotherapy, or other Grade ≥ 3 drug-related CNS toxicity.\n4. Active systemic autoimmune disease or a history of autoimmune disorder that may relapse (e.g., systemic lupus erythematosus \\[SLE\\], rheumatoid arthritis, inflammatory bowel disease \\[IBD\\], autoimmune thyroid disorder\\*, multiple sclerosis, vasculitis, glomerulitis, eczema, psoriasis, etc.).\n\n   \\*Note that primary or secondary hypothyroidism, well controlled with hormone replacement therapy is permitted.\n5. Major trauma or major surgery within 4 weeks prior to Day 1 or anticipated major surgery during study participation.\n6. Serious unhealing wound, ulcer, or bone fracture.\n7. History of and\u002For presence of any of the following cardiovascular and cerebrovascular events or conditions:\n\n   1. History of myocardial infarction, unstable or severe angina, or arterial thrombotic event (such as cerebrovascular attack \\[CVA\\] or transient ischemic attack \\[TIA\\]) within 12 months prior to Day 1.\n   2. Significant abnormalities on the screening of ECG, including corrected QT interval (QTc interval) \\> 470 msec (average of triplicate measurements, corrected for heart rate using Fridericia's formula), second degree (Mobitz type II) or third degree atrioventricular (AV) block, or other clinically significant (in the Investigator's opinion) arrhythmia.\n   3. Current New York Heart Association (NYHA) stage II-IV congestive heart failure (CHF).\n   4. Left ventricular ejection fraction (LVEF) \\< 50%.\n\n      • Note that LVEF assessment by echocardiogram (ECHO) scan performed as part of the patient's regular care within 4 weeks prior to the screening visit may be used for confirmation of eligibility.\n   5. Other clinically significant (in the Investigator's opinion) cardiac diseases (e.g., valvular disease, cardiomegaly, ventricular hypertrophy, cardiomyopathy, myocarditis, etc.).\n   6. Uncontrolled hypertension (defined as a systolic blood pressure \\[SBP\\] ≥ 150 mmHg and\u002For diastolic blood pressure (DBP) ≥ 100 mmHg at screening), despite appropriate antihypertensive therapy, or poor compliance with an antihypertensive regimen.\n8. Active or recent (past 6 months) bleeding disorder, including gastrointestinal (GI) bleeding, as evidenced by hematemesis, significant hemoptysis, or melena within 6 months prior to Day 1.\n9. Uncontrolled diabetes.\n10. Chronic severe liver disease or Child-Pugh B or C liver cirrhosis.\n11. History of alcoholism or drug abuse within the past year.",{"count":357,"type":20},68,[23,141],"This Phase 1\u002F2a study will explore the safety and efficacy of PTT-936, an Alpha Kinase 1 (ALPK1) activator, used alone or in combination with anti-PD-1\u002FL1 therapy in patients with locally advanced or metastatic solid tumors. The study is divided into two parts: Phase 1 (Part A) focuses on determining the pharmaceutically active dosage range and evaluating the safety profile of PTT-936 when administered as a monotherapy. Phase 2a (Part B) will assess the safety and efficacy of PTT-936 combined with anti-PD-1\u002FL1 therapy in patients suitable for anti- PD-1\u002FL1 monotherapy. The study aims to understand how PTT-936, alone or in combination, impacts tumor progression and patients' overall response.",[26],[145],"2025-03-07",{"date":364,"type":36},"2025-03-12",{"date":366,"type":36},"2024-01-26",{"date":368,"type":20},"2026-02-28",{"name":370,"class":43},"Pyrotech Therapeutics, Inc.",3,{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":21,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":393},"100538654","phase-1-clinical-trial-to-investigate-safety-tolerability-pharmacokinetics-pharmacodynamics-and-efficacy-of-da-4505-as-a-single-agent-and-in-combination-with-pembrolizumab-in-adult-patients-with-locally-advanced-or-metastatic-solid-tumors-100538654","NCT06293651","Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors","an Open-Label, Phase 1\u002F2a, First-in-Human Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Aged 18 and older.\n2. Capable of giving signed informed consent.\n3. Diagnosed with particular disease characteristics.\n4. Expected survival ≥ 3 months.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n6. A female patient is eligible to participate if she is not pregnant or breastfeeding.\n7. A male patient is eligible to participate if he agrees to remain abstinent or use a male condom when having sexual intercourse with a WOCBP, or if he has had a bilateral vasectomy.\n8. Have measurable disease by revised RECIST v1.1 criteria.\n\nExclusion Criteria:\n\n1. Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.\n2. Current enrollment or past participation in another clinical trial.\n3. Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy.\n4. Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy.\n5. Autologous transplantation within 60 days.\n6. Prior allogeneic transplantation.\n7. Major surgery within 30 days, or unresolved complications after a major or minor surgery.\n8. History of or currently active cardiovascular disease.\n9. Clinically significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.\n10. History of other malignancy.",{"count":380,"type":20},125,[23,141],"This study is an Open-Label, Phase 1\u002F2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors.",[26],"2025-02-10",{"date":386,"type":36},"2025-02-12",{"date":388,"type":36},"2024-04-18",{"date":390,"type":20},"2029-10",{"name":392,"class":43},"Dong-A ST Co., Ltd.",2,{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":21,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":69},"100548212","phase-1-study-of-ibi3005-in-subjects-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100548212","NCT06418061","Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors","A Multicenter, Open-label, Phase Ia\u002FIb Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI3005 in Subjects With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\nSubjects Should have been previously treated with a third-generation EGFR TKI with disease progression. Subjects with positive other driver genes or METex14 mutations are required to undergo targeted therapy and disease progression.\n\nExclusion Criteria:\n\nReceived live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study.Patients are allowed to receive inactivated vaccines.\n\nUncontrolled diseases including:\n\n* Infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose of the study drug（ antiviral medication for hepatitis B and hepatitis C infection that are compliant with the protocol were allowed）;\n* Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1\u002F2 Ab positive);\n* Acute or chronic active hepatitis B (HbsAg positive and\u002For HbcAb positive with HBV DNA titer ≥ 104 copies\u002FmL or ≥ 2000 IU\u002FmL or higher than lower limit of detection) or C (HCV Ab positive with HCV RNA titer \\> 103 copies\u002FmL or higher than lower limit of detection);\n* Active COVID-19 infection with obvious symptoms requiring treatment or hospitalization, such as pyrexia, dyspnea, nausea, vomiting, diarrhea, etc.;\n* Active tuberculosis infection, or still on anti-tuberculosis therapy or received anti tuberculosis therapy within 1 year prior to first administration of the study drug;\n* Active syphilis infection or latent syphilis requiring treatment;\n* Symptomatic congestive heart failure Grade II-IV (New York Heart Association \\[NYHA\\]), symptomatic or uncontrolled arrhythmias, QTc interval \\> 480 ms or personal or family history of congenital long\u002Fshort QT syndrome;\n* Hypertension that does not receive standardized therapy or still uncontrollable hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg); Any history of life-threatening hemorrhage, or hemorrhage requiring (including but not limited to gastrointestinal bleeding, hemoptysis, etc) blood transfusion, endoscopy, or surgery, within 3 months prior to the first administration of study drug;",{"count":402,"type":20},198,[23],"The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.",[406,26],"Unresectable","2025-01-19",{"date":409,"type":36},"2025-01-22",{"date":411,"type":36},"2025-01-08",{"date":413,"type":20},"2027-12-31",{"name":415,"class":43},"Innovent Biologics (Suzhou) Co. Ltd.",{"id":417,"slug":418,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":424,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":21,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":69},"100534995","phase-1-a-study-of-tyk-00540-in-adult-patients-with-solid-tumors-100534995","NCT06246071","A Study of TYK-00540 in Adult Patients With Solid Tumors","A Phase Ia\u002FIb, Multicenter, Open-label Study of TYK-00540, Administered Orally in Adult Patients With Locally Advanced\u002FMetastatic Solid Tumors","ASOTIAPWST","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. In the Single-agent escalation phase, subjects should fulfill the following criterion at Screening: Histologically or cytologically confirmed locally advanced\u002Fmetastatic solid tumors that do not have, failed or intolerated standard of care (SOC).In the single-agent expansion phase, subjects should fulfill the following criteria at Screening: Cohort 1: Histologically or cytologically confirmed platinum-resistant HGSOC (Platinum-resistant: responds at first to treatment with drugs that contain platinum, but then comes back within 6 months period; only female subjects will be enrolled). Cohort 2: Histologically or cytologically confirmed locally advanced\u002Fmetastatic TNBC who have received two lines of standard of care (SOC) regimens, including:\n\n   1. Any prior treatment can be considered as one of the SOC regimens if executed on patients with the receptor status of triple-negative no matter the previous pathological type;\n   2. For patients whose treatment have been changed due to intolerability to toxicity, the intolerable regimens can be included as one of the prior standards of care regimens;\n   3. For neoadjuvant and\u002For adjuvant chemotherapy, if relapse or disease progression to locally advanced or metastatic disease occurs during treatment or within 12 months after discontinuation of treatment (at least 2 cycles have been completed), it will be considered as one of the SOC regimens;\n   4. For patients with documented germline BRCA1\u002FBRCA2 mutations, if they have been treated with an approved PARP inhibitor, then the PARP inhibitor can be considered as one of the 2 lines of prior SOC regimens required.\n\n   In the combination-agent escalation and combination expansion phase (Cohort 3), subjects should fulfill the following criteria at Screening: ER+\u002FHER2-breast cancer with who have relapsed or progressed after treatment with CDK4\u002F6 inhibitors (no prior treatment of fulvestrant or other SERDs, SERCA; no contraindications to the use of fulvestrant; for locally advanced or metastatic disease stages, the number of chemotherapy lines≤ 1). Note: Histologically-confirmed breast carcinoma expressing positive ER (≥1% tumor cells expressing ER as positive on IHC staining, recommended by ASCO\u002FCAP Guideline Update 2020. For the purposes of the expansion study, only ER+ IHC staining ≥10% will be considered ER+ in this cohort. Negative HER2 is defined as IHC 0 or 1+, or IHC 2+ but confirmed by the negative ISH, recommended by ASCO\u002FCAP Guideline 2018.\n3. Subjects in the escalation phase should have measurable or evaluable lesions at baseline; Measurable lesions required in the expansion phase (RECIST 1.1).\n4. ECOG performance status is 0 to 1 and there is no deterioration in the 2 weeks prior to the first dose.\n5. Life expectancy of at least 3 months.\n6. Adequate organ functions, defined as: ALT or AST ≤ 2.5×the upper limit of normal (ULN) or ≤ 5 ×ULN with documented liver involvement (such as liver metastasis or a primary biliary tumor) and Total bilirubin ≤ 1.5 ×ULN (subjects with Gilbert's Disease may be enrolled with Sponsor approval); Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL, Platelet count ≥ 80 ×109\u002FL and Hemoglobin (Hb) ≥ 9 mg\u002FdL, not requiring growth factor and transfusion support for at least 14 days prior to screening; Adequate renal function, creatinine clearance ≥ 60 mL\u002Fmin (According to the Cockcroft and Gault formula). Coagulation function: International normalized ratio (INR) ≤ 1.5 ×ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. Left ventricular ejection fraction (LVEF) ≥50%.\n7. Willing and able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).\n8. Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and 6 months following the last dose of study treatment; this may include barrier methods such as condom or diaphragm with spermicidal gel.\n\nExclusion Criteria:\n\n1. Known allergy to any excipients of TYK-00540 tablets (for combination-agent escalation phase and combination expansion phase, known contraindications to fulvestrant should also be considered).\n2. Subjects with prior therapy of: Systemic anti-tumor treatment such as standard chemotherapy, macromolecular targeted drugs and immunological drug therapy within 28 days prior to the first dose; reception of endocrine therapy, small molecule targeted drugs and oral fluorouracil within 14 days before the first dose; reception of nitrosoureas and mitomycin within 6 weeks prior to the first dose Major surgery (except minor surgeries such as appendicitis and tumor biopsy) within 4 weeks prior to the planned start of TYK-00540. Subjects who have taken proton pump inhibitors (PPIs) within 7 days prior to the first dose of TYK-00540, or require continuation of therapy during the study. Subjects who were receiving and need to continue treatment with medications known to prolong the QTc interval or potentially cause Torsade de pointe ventricular tachycardia during the treatment. Participation in other clinical trials (excluding non-interventional drug clinical trials) within 28 days prior to the first dose; Prior allogeneic bone marrow transplantation.\n3. Subjects with other malignancies or a history of other malignant tumors, except for cured basal cell carcinoma of the skin or squamous cell carcinoma, carcinoma in situ of the cervix, papillary thyroid cancer, carcinoma in situ of the breast duct, or other malignant tumors that have survived for more than 5 years.\n4. Any unresolved toxicities from prior therapy greater than NCI CTCAE Grade 1 at the time of starting study treatment with the exception of Grade 2 alopecia and prior platinum-therapy related neuropathy.\n5. Patients with primary central nervous system (CNS) tumors or CNS metastases that have failed local therapy. Patients who are asymptomatic or clinically stable and do not require steroids and other treatments for CNS metastases ≥ 28 days and are radiographically stable during the screening period may be enrolled.\n6. The subject has symptoms of spinal cord compression due to the tumor.\n7. Uncontrollable or poorly controlled effusion of chest, abdomen, pelvis, or pericardium.\n8. Any baseline 12-lead ECG abnormalities which may impair the safety of subjects (such as baseline QTc interval ≥ 470 msec, complete left bundle branch block (LBBB), acute or unspecified myocardial infarction, active myocardial ischemic ST-T segment changes with clinical significance, second- or third-degree atrioventricular (AV) block, or severe bradycardia or tachycardia).\n9. Have had any of the following in the past 6 months: myocardial infarction, long QT syndrome, torsades de pointes, arrhythmias (double-bundle branch block, such as right bundle branch block (RBBB) with left anterior or posterior branch block, third-degree atrioventricular block) , unstable angina, coronary\u002Fperipheral artery bypass grafting, symptomatic chronic heart failure (CHF), Grade III or IV cardiac function as defined by the New York Heart Association, cerebrovascular accident, transient cerebral ischemia, symptomatic pulmonary embolism, and\u002For other clinically significant thromboembolic disease episodes. NCI CTCAE ≥ Grade 2 persistent arrhythmia, any grade of atrial fibrillation (asymptomatic uncomplicated atrial fibrillation was required to be of ≥Grade 2). Enrollment of patients who have an implanted cardiac rhythm device\u002Fpacemaker with QTcF \\> 470 msec needs to be discussed by the investigators and sponsor.\n10. Subjects with any other disease or medical condition that is unstable or could affect their safety or study compliance, any serious or uncontrolled systemic disease, including uncontrolled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg). Uncontrolled diabetes, active bleeding, ocular lesions, and other serious mental, neurological, cardiovascular or respiratory system diseases.\n11. Known active infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection, except for asymptomatic chronic HBV or HCV carriers. Active HBV, HCV, or HIV infections are defined as:\n\n    1. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥ 2000 cps\u002FmL or 500 IU\u002FmL; HBsAg-negative, anti-HBc-positive patients are at high risk of HBV reactivation who require suppressive antiviral therapy prior to initiation of cancer therapy;\n    2. Anti-HCV antibody positive and HCV-RNA \\> upper normal limit defined by sites;\n    3. Anti-HIV antibody positive with uncontrolled opportunistic infections; anti-HIV antibody positive with CD4+ count\\\u003C 350 cells\u002FuL that requires HIV therapy prior to the cancer treatment; other conditions allowing concurrent ART but the therapy not tolerated and that the toxicities confused with investigational drug toxicities.\n12. History of positively diagnosed interstitial lung disease or interstitial pneumonia (ILD), drug-induced ILD, or radiation pneumonitis requiring hormone therapy, or any evidence of active ILD (e.g., acute onset or progressive pneumonitis\u002Fpulmonary fibrosis at baseline), or the pulmonary symptoms which are not suitable for enrollment in the investigator's judgment or the high-risk factors which may cause interstitial lung disease and are not suitable for enrollment.\n13. Clinically significant gastrointestinal abnormalities at screening that may affect the intake, transport or absorption of drugs (such as dysphagia, uncontrollable nausea and vomiting, active gastric ulcer, ulcerative colitis, Crohn's disease, chronic diarrhea, intestinal obstruction, gastric diseases requiring long-term administration of PPIs without a cure, etc.).\n14. Clinically significant hypercoagulability.\n15. Pregnant and lactating women.\n16. Subjects who, in the opinion of the investigator, would not be suitable for participation in this study (e.g., not in line with the treatment of the subject's best benefit, subject compliance, etc.).",true,{"count":426,"type":20},156,[23],"The primary objective of this study is to evaluate the safety and tolerability of TYK-00540, with dose-escalation stage and dose-expansion stage.",[26],"2024-02-06",{"date":432,"type":36},"2024-02-07",{"date":434,"type":36},"2024-01-02",{"date":436,"type":20},"2026-12-05",{"name":438,"class":43},"TYK Medicines, Inc",{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":209,"enrollmentInfo":446,"targetDuration":4,"studyType":21,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":69},"100493027","phase-1-ifn-expressing-mesenchymal-stromal-cells-for-locally-advancedmetastatic-solid-tumors-100493027","NCT05699811","IFNα Expressing Mesenchymal Stromal Cells for Locally Advanced\u002FMetastatic Solid Tumors","Phase I\u002FII Trial of Allograft Engineered MSC-IFNα Combined With or Without Immunochemotherapy for Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Age from 18 to 75 years with estimated life expectancy \\>3 months.\n2. Histopathological confirmed locally advanced or metastatic solid tumors including, but not limited to, lung cancer, breast cancer, colorectal cancer, hepatocellular carcinoma, and sarcomas.\n3. Failed to at least first-line and second-line treatments or initially diagnosed locally advanced\u002Fmetastatic solid tumors that have no National Comprehensive Cancer Network(NCCN) guideline-recommended therapy.\n4. Have at least one measurable target lesion.\n5. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study.\n6. Have an Eastern Cooperative Oncology Group performance status (ECOG) of 0 to 2 at the time of enrollment.\n7. Have adequate organ function, which should be confirmed within 2 weeks prior to the first dose of study drugs.\n8. Previous treatment with anti-PD-1\u002FPD-L1 antibodies is allowed.\n9. Ability to understand and sign a written informed consent document.\n10. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and up to 90 days after the last dose of the drug.\n\nExclusion Criteria:\n\n1. Active, known, or suspected autoimmune diseases.\n2. Known brain metastases or active central nervous system (CNS). Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms, and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening.\n3. Subjects are being treated with either corticosteroid (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.\n4. History of psychiatric disorders including depression, suicidality, and mania.\n5. History of allergy or intolerance to study drug components.\n6. Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.\n7. Uncontrolled concurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia), or psychiatric illness\u002Fsocial situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.\n8. History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).\n9. Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before enrollment, and a negative result must be documented.\n10. Previous or concurrent cancer within 3 years prior to treatment start.",{"count":447,"type":20},40,[23,141],"The goal of this first-in-human, single-center, prospective, open-label, phase 1\u002F2 trial is to evaluate the safety and efficacy of the interferon alpha expressing mesenchymal stromal cells (MSC-IFNα) combined with or without immunochemotherapy in patients with locally advanced\u002Fmetastatic solid tumors. The main questions aimed to answer are 1) to evaluate the safety and feasibility of MSC-IFNα in the treatment of locally advanced\u002Fmetastatic solid tumors;2) to evaluate the anti-tumor effects of the MSC-IFNα combined with or without immunochemotherapy in the treatment of locally advanced\u002Fmetastatic solid tumors; 3) to evaluate the pharmacokinetics\u002Fpharmacodynamics of MSC-IFNα and related immune effector cells.",[26],"2023-04-27",{"date":453,"type":36},"2023-04-28",{"date":455,"type":36},"2023-02-23",{"date":457,"type":20},"2026-12-31",{"name":459,"class":257},"Chinese PLA General Hospital",{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":21,"phases":469,"briefSummary":470,"conditions":471,"keywords":473,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":69},"100438963","phase-1-a-study-of-xzp-5955-tablets-in-patients-with-ntrk-or-ros1-fusion-positive-locally-advanced-or-metastatic-solid-tumors-100438963","NCT04996121","A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors","The Safety Tolerability Pharmacokinetic Characteristics and Efficacy of XZP-5955 Tablets in Patients With NTRK or ROS1 Gene Fusion Locally Advanced or Metastatic Solid Tumors in a Single-arm Open-label Multi-center Phase I\u002FII Clinical Study","Inclusion Criteria:\n\n1. Male or female subjects aged ≥18 years old;\n2. Phase I dose escalation period: Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor, assessed by investigator that no standard therapy exists, or the tumor has relapsed, progressed or was nonresponsive to available therapies, or intolerance, or not suitable to standard therapy at current stage. Priority will be given to patients who have previously documented NTRK or ROS1 gene fusion confirmed by the central laboratory; Phase I dose expansion and Phase II: Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor, patients can provide a written report of pathological diagnosis of NTRK or ROS1 positive tested by qualified laboratory;\n3. Phase I dose expansion cohort 1 and Phase II cohort 1: locally advanced, or metastatic solid tumor with NTRK gene fusion Phase I dose expansion cohort 2 and Phase II cohort 2： locally advanced, or metastatic NSCLC with ROS1 gene fusion that has progressed to crizotinib and other therapies or was intolerance to crizotinib Phase I dose expansion cohort 3: locally advanced, or metastatic NSCLC with ROS1 gene fusion who have not previously received crizotinib or other therapy.\n4. phase I dose escalation: at least 1 measurable target lesion according to RECIST version 1.1 Phase I dose expansion and Phase II: at least 1 measurable target lesion according to RECIST version 1.1 (Tumor lesions treated with prior radiation or other local treatment are considered measurable if they show definite progression)\n5. ECOG PS 0-1\n6. Life expectancy ≥ 3 months.\n7. Adequate organ function:\n\n   Baseline laboratory values fulfilling the following requirements: Absolute neutrophils count (ANC) ≥1.5 × 109\u002FL; Platelets (PLTs) ≥75 × 109\u002FL; Hemoglobin ≥ 85g\u002FL; Serum creatinine≤ 1.5 × ULN， or creatinine clearance ≥50 mL\u002Fmin\u002F1.73m2(only when serum creatinine\\>1.5 × ULN); Total serum bilirubin ≤1.5 × ULN; Liver transaminases (AST\u002FALT) ≤ 2.5 × ULN，≤3× ULN if liver metastases are present or liver cancer patients; Activated Partial Thromboplastin Time≤1.5× ULN；International Normalized Ratio (INR)≤1.5× ULN；\n8. Eligible patients (male and female) who are fertile must agree to at least use a reliable contraceptive method with partner during the trial and within 90 days from the last dose; Women of childbearing age must have a negative serum pregnancy test within 7 days before the first dose of the trial.\n\nExclusion Criteria:\n\n1. Received anti-tumor therapy such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy or other therapy within 4 weeks prior to the first dose of the investigational drug except the following:\n\n   Nitroso ureas or mitomycin C within 6 weeks before the first dose of the drug; Oral fluorouracil and small molecule targeted drugs within 2 weeks prior to the first dose of drug or within 5 half life (whichever is longer);\n2. Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug;\n3. Major organ surgery (except biopsy) or significant trauma within 4 weeks prior to first dose of the investigational drug or required elective surgery during the trial;\n4. Adverse reactions to previous antitumor therapy have not recovered to NCI CTCAE 5.0 ≤ grade 1 (except for alopecia, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.);\n5. Inability to swallow drug, or a condition that the investigator judged to severely affect gastrointestinal absorption (eg:Chronic Diarrhea, intestinal obstruction, etc.);\n6. Cerebral or meningeal metastases with clinical symptoms. The below patients were allowed to be included: those who were asymptomatic, stable, and did not require steroid treatment for more than 4 weeks prior to the start of study treatment (if the cerebral metastases had undergone radiotherapy or\u002Fand surgery, radiotherapy and surgery should be at least 1 month prior to the first dose) ;\n7. Known active infections and currently need intravenous anti-infective therapy;\n8. History of immune deficiencies, including positive HIV antibody tests;\n9. Active Hepatitis B (HBsAg and\u002For HBcAb positive with HBV-DNA \\> 500IU\u002Fml) or hepatitis c virus infection (positive test results of anti-HCV with positive HCV-RNA );\n10. Known interstitial lung disease (except for radioactive pulmonary fibrosis that does not require steroid therapy);\n11. History of serious cardiovascular disease;\n12. Pregnant or lactating women.",{"count":468,"type":20},360,[23,141],"A phase I\u002FII study to examine the safety, tolerability, pharmacokinetics and efficacy of XZP-5955 tablets in patients with advanced solid tumors harboring NTRK or ROS1 gene fusion",[26,472],"Locally Advanced or Metastatic Non-small Cell Lung Cancer",[474,475,476],"XZP-5955","Safety, tolerability, pharmacokinetics and efficacy","Solid tumors with NTRK or ROS1 gene fusion","2022-08-28",{"date":479,"type":36},"2022-08-30",{"date":481,"type":36},"2021-12-06",{"date":483,"type":20},"2027-06",{"name":485,"class":43},"Xuanzhu Biopharmaceutical Co., Ltd."]