[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,40,63,85,114,136,158,185,205],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100640093","phase-1-a-study-in-people-with-advanced-cancer-to-test-how-well-different-doses-of-bi-3819026-are-tolerated-when-taken-alone-and-together-with-ezabenlimab-100640093",false,"NCT07607678","A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab","A First-in-human Phase I, Open-label, Multicentre, Dose Escalation Trial of BI 3819026 in Combination With Ezabenlimab in Patients With Unresectable Advanced or Metastatic Solid Cancers to Determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE)","Inclusion Criteria :\n\n1. Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory to or ineligible for established and available therapies with proven clinical benefit, or have declined such therapy.\n2. At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1\n3. Patients with brain metastases are eligible provided they meet the following criteria:\n\n   * Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the investigator,\n   * Radiotherapy and\u002For surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,\n   * Patient is off steroids and anti-convulsive drugs for at least 7 days prior to the first administration of BI 3819026 and has no requirement for such therapy at the time of initiating trial treatment.\n4. Availability of archived formalin-fixed and paraffin embedded (FFPE) tumour tissue. Patients who do not have archived FFPE tumour tissue available may be allowed to enrol without archival tumour tissue upon agreement between the investigator and the Sponsor\n5. All toxicities related to previous anti-cancer therapies have resolved to Grade ≤1 or baseline prior to trial treatment administration (except for alopecia, peripheral neuropathy and endocrinopathies considered irreversible \\[like hypothyroidism\\], and amenorrhea\u002Fmenstrual disorders which can be any grade)\n6. Adequate liver, bone marrow and renal organ function Further inclusion criteria apply.\n\nExclusion Criteria :\n\n1. Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:\n\n   * Effectively treated non-melanoma skin cancers\n   * Effectively treated carcinoma in situ of the cervix\n   * Effectively treated ductal carcinoma in situ of the breast\n   * Other effectively treated malignancy that is considered cured by local treatment\n2. Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)\n3. Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment\n4. Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:\n\n   * Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior and is not on the target lesion (which should be outside of the radiation field)\n   * Single dose palliative radiotherapy for symptomatic metastasis that is not the target lesion (which should be outside of the radiation field) within 2 weeks prior may be allowed\n5. Active\u002Fprevious history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)\n6. Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, e.g. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma\u002Fatopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and\u002For controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible\n7. Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)\n8. Patients with history of HIV infection who meet one or more of the following criteria:\n\n   * CD4+ count \\\u003C350 cells\u002FµL\n   * Viral load \\>400 copies\u002FmL\n   * Not receiving antiretroviral therapy\n   * Receiving established antiretroviral therapy for less than four weeks prior to the start of trial treatment\n   * History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the exclusion criteria above are eligible to participate but the patient must be under the care of an HIV\u002FInfectious Diseases specialist, or an HIV\u002FInfectious Diseases specialist must be consulted prior to inclusion Further exclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer.\n\nParticipants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study.\n\nParticipants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.",[26,27],"Advanced Solid Cancer","Metastatic Solid Cancer","RECRUITING","2026-05-27",{"date":31,"type":32},"2026-05-29","ACTUAL",{"date":34,"type":32},"2026-05-01",{"date":36,"type":20},"2030-10-15",{"name":38,"class":39},"Boehringer Ingelheim","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":62},"100639446","phase-1-sim0613-in-participants-with-advanced-solid-tumors-100639446","NCT07618260","SIM0613 in Participants With Advanced Solid Tumors","A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0613 in Participants With Advanced Solid Tumors","SIM0613-101","Inclusion Criteria:\n\n1. Written informed consent (ICF) is obtained prior to any of the specified procedures required for the study\n2. ≥18 years of age\n3. Histologically or cytologically confirmed locally advanced\u002Fmetastatic solid tumors\n4. Have at least one measurable disease per RECIST Version 1.1 criteria\n5. Have experienced disease progression on\u002Fafter at least one accessible standard therapy, or are intolerant to standard therapy, or are not suitable for standard therapy, or for whom clinical trial of the investigational drug serves as standard treatment\n6. Life expectancy of ≥12 weeks\n7. Have adequate organ function\n8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to the start of study treatment.\n9. For Part 1, archival or fresh tumor tissue sample (preferably 12 with a minimum number of 10 sections) should be collected if available at Biomarker-screening or screening visit. For Part 2, it is mandatory to collect archival tumor tissue sample (preferably 12 with a minimum number of 10 sections) performed within 6 months prior to consent or fresh tumor tissue sample at Biomarker-screening or screening visit\n\nExclusion Criteria：\n\n1. Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast)\n2. Participants with symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery), or CNS metastases requiring corticosteroids therapy within 2 weeks of first dose of study treatment.\n3. History of bowel obstruction within 3 months prior to the first dose of study treatment.\n4. Known psychiatric disorder or drug abuse that would interfere the study requirements\n5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment\n6. Any active infection requires systemic treatment via intravenous infusion within 2 weeks prior to the first dose of study treatment\n7. Has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.\n8. Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of SIM0613.\n9. Major surgery within 2 weeks of receiving the first dose of study treatment (minor procedures such as mediastinoscopy, insertion of a central venous access device, insertion of a feeding tube, needle biopsy and percutaneous nephrostomy are not considered major surgery)\n10. Prior exposure to topoisomerase I (TOP-I) inhibitor inhibitor-based antibody-drug conjugate (ADC) therapies or LRRC15-targeted therapies.\n11. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment\n12. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS)\n13. Active hepatitis B (HBsAg or HBcAb positive）\n14. History of allogeneic organ transplantation or graft-versus-host disease\n15. Known hypersensitivity to study drug or any of the excipients\n16. Participant is pregnant or breastfeeding\n17. Other conditions that researchers consider inappropriate for inclusion.",{"count":49,"type":20},294,[23],"This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, efficacy and pharmacokinetic\u002Fpharmacodynamic characteristics of SIM0613 in participants with locally advanced\u002F metastatic solid tumors. The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2).",[26],"2026-05-26",{"date":55,"type":32},"2026-06-01",{"date":57,"type":32},"2026-05-15",{"date":59,"type":20},"2028-12",{"name":61,"class":39},"Jiangsu Simcere Pharmaceutical Co., Ltd.",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100613387","phase-1-a-phase-i-study-of-sim0609-in-adult-participants-with-locally-advancedmetastatic-solid-tumors-100613387","NCT07265921","A Phase I Study of SIM0609 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","A Phase I First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Solid Tumors","Inclusion Criteria:\n\n1. Voluntary participation and signature of informed consent form;\n2. At least 18 years old, male or female;\n3. Participants with histologically and\u002For cytologically confirmed locally advanced\u002Fmetastatic solid tumors;\n4. Participants should have at least one evaluable or measurable tumor lesion;\n5. Participants have failed the standard of therapy in the locally advanced\u002Fmetastatic setting;\n6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;\n7. Expected survival ≥12 weeks;\n8. Adequate organ and bone marrow function;\n9. Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 28 days before first administration, is mandatory\n\nExclusion Criteria:\n\n1. Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence;\n2. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring CNS-directed local therapy or corticosteroid treatment that occurred within 2 weeks prior to the first administration of the investigational treatment;\n3. Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging screening;\n4. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study ;\n5. Any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment;\n6. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment;\n7. Not recovered from previous anticancer therapy-induced AEs(Adverse Events);\n8. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment;\n9. Received prior therapies within the following time frames prior to the first dose of study treatment:\n\n   1. Previous cytotoxic therapy, anticancer targeted small molecules within 2 weeks.\n   2. Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).\n   3. Chinese medicines\u002Fherbal preparations with anticancer indication taken within 2 weeks.\n   4. Radiation therapy within 4 weeks.\n10. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody drug conjugate (ADC) therapies or CDH17-targeted ADC therapies.\n11. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.\n12. Administration of below medications ≤14 days prior to the first dose of study treatment.\n\n    1. Strong or moderate CYP3A4 inducers\u002Finhibitors;\n    2. Drugs with known risk of Torsades de Pointes(TdP);\n    3. Drugs that may prolong the QT interval;\n13. Major surgery within 2 weeks of receiving the first dose of study treatment;\n14. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome ;\n15. Active or chronic hepatitis B or hepatitis C infection;\n16. Participants with clinically significant cardiovascular diseases;\n17. History of allogeneic organ transplantation or graft-versus-host disease;\n18. History of hypersensitivity to active or inactive excipients of SIM0609 or drugs with a similar chemical structure or class to SIM0609;\n19. Pregnant or nursing (lactating) women;\n20. Male participants with female partners of reproductive potential, unless they are using highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of study treatment;\n21. Presence of any other condition that may increase the risk associate with study participant or may interfere with the interpretation of study results, and, in the opinion of the Investigator, would make the participant inappropriate for entry into the study.",{"count":72,"type":20},232,[23],"This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced\u002FMetastatic Solid Tumors",[26],"2025-12-04",{"date":78,"type":32},"2025-12-05",{"date":80,"type":32},"2025-11-07",{"date":82,"type":20},"2029-06",{"name":61,"class":39},6,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":110,"locationsCount":113},"100602431","phase-1-a-phase-1-study-of-apx-343a-as-monotherapy-or-in-combination-with-pembrolizumab-in-subjects-with-advanced-solid-tumors-100602431","NCT07123415","A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors","A Phase 1 Trial of APX-343A as Monotherapy or in Combination With Pembrolizumab to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female subjects aged ≥19 years, inclusive, at the time of informed consent.\n2. Willing and able to give informed consent and to comply with the requirements of the study.\n3. Histologically or cytologically confirmed advanced solid tumor.\n4. Life expectancy of at least 3 months in the judgment of the investigator.\n5. ECOG performance status of 0 to 1 during the screening period.\n6. Measurable disease per RECIST v1.1 as assessed by the site investigator\u002Fradiology.\n7. Archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated has been provided.\n8. Subjects who have AEs due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline.\n9. Adequate organ function as defined in the following table.\n10. Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to the first dose of study drug.\n11. Subjects with history of HCV infection are eligible if HCV viral load is undetectable at screening.\n12. Male subjects must agree to use an adequate method of contraception.\n13. Female subjects of childbearing potential must agree to use highly effective contraceptive methods, and to abstain from breastfeeding.\n\nExclusion Criteria:\n\n1. Received any prior immunotherapy.\n2. Received prior systemic anticancer therapy including investigational agents.\n3. Received prior radiotherapy.\n4. Received a live or live-attenuated vaccine .\n5. Has received an investigational agent.\n6. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.\n7. Known additional malignancy.\n8. Known active CNS metastases and\u002For carcinomatous meningitis.\n9. Active autoimmune disease.\n10. History of (noninfectious) pneumonitis\u002Finterstitial lung disease.\n11. Active, uncontrolled infection requiring systemic therapy.\n12. Unable to swallow study drug or disease that interfere with proper absorption of study drug.\n13. Significant cardiovascular disease.\n14. Cerebrovascular accident.\n15. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the subject's ability to cooperate with the requirements of the study.\n16. History of severe hypersensitivity to pembrolizumab and\u002For any of its excipients.\n17. History of hypersensitivity to APX-343A and\u002For any of its excipients.\n18. History of allogeneic tissue\u002Fsolid organ transplant.\n19. History of HIV infection or HIV positive at screening.\n20. Subjects who have not adequately recovered from major surgery or have ongoing surgical complications.","19 Years",{"count":94,"type":20},110,[23],"This is a Phase 1, open-label, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of APX-343A monotherapy (Part A) and in combination with pembrolizumab (Part B) in subjects with advanced solid tumors.",[26,98],"Advanced Solid Tumor (Phase 1)",[26,98,100,101,102,103],"APX-343A","ICI","CAF","NOX","2025-11-17",{"date":106,"type":32},"2025-11-19",{"date":108,"type":32},"2025-10-24",{"date":59,"type":20},{"name":111,"class":112},"Aptabio Therapeutics, Inc.","INDIV",3,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":62},"100608055","phase-1-personalized-kxv01-tcr-lentinvivo-injection-as-the-therapy-for-advanced-solid-tumors-100608055","NCT07196579","Personalized KXV01 TCR Lentinvivo Injection as the Therapy for Advanced Solid Tumors","Screening Period 1\n\nInclusion Criteria 1:\n\n1. Voluntarily participate in the clinical study; fully understand the study and voluntarily sign the informed consent form; be willing to comply with and able to complete all trial procedures.\n2. Aged 18 to 70 years (inclusive).\n3. Histologically or cytologically confirmed incurable or metastatic solid tumors that have failed standard treatment, or for which no standard treatment is currently available.\n4. Expected survival time \\> 6 months.\n5. ECOG performance status of 0 or 1.\n6. Sufficient organ function, defined as follows:\n\n   6.2.1) Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) in the absence of significant hepatic lesions (primary or metastatic), and ≤ 3 × ULN in subjects with hepatic lesions or Gilbert's disease; 6.2.2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in subjects with liver metastasis or liver cancer); alkaline phosphatase (ALP) ≤ 2.5 × ULN (≤ 5 × ULN in subjects with bone metastasis); 6.3) Renal function: Creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula: (\\[140 - age\\] × weight \\[kg\\] × \\[0.85, for females only\\]) \u002F (72 × creatinine (mg\u002Fdl))); 6.4) Baseline oxygen saturation \\> 92% during natural breathing (without auxiliary oxygen supply).\n7. Patients whose tumor lesions can be collected and from whom tumor-reactive TCR sequences can be identified may enter the study. If a patient has obtained individualized TCR sequences from previously collected archived tumor tissue in other studies, they may directly enter Screening Period 2, provided that the archived tissue was collected within one year prior to signing the informed consent form for this study.\n8. Women of childbearing age must have a negative urine\u002Fblood pregnancy test during the screening period and agree to use contraceptive measures for at least 1 year after administration; male subjects whose partners are of childbearing potential must agree to use effective barrier contraception for at least 1 year after administration.\n\n6.1) Hematological system: 6.1.1) Hemoglobin ≥ 90 g\u002FL (no blood transfusion within 14 days prior to the test); 6.1.2) Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL (no granulocyte colony-stimulating factor treatment within 14 days prior to the test); 6.1.3) Platelet count ≥ 100 × 10⁹\u002FL in the absence of significant hepatic lesions (primary or metastatic) (no platelet transfusion within 14 days prior to the test), or ≥ 75 × 10⁹\u002FL in the presence of hepatic lesions (no platelet transfusion within 14 days prior to the test); 6.1.4) Absolute lymphocyte count (ALC) ≥ 0.7 × 10⁹\u002FL; 6.2) Hepatic function:\n\nExclusion Criteria 1:\n\n1. A history of other malignant tumors within 2 years prior to signing the informed consent form, except for non-melanoma skin cancer, some in situ carcinomas (e.g., cervical cancer, bladder cancer, breast cancer), or low-risk prostate cancer.\n2. Uncontrolled infectious diseases within 4 weeks prior to signing the informed consent form.\n3. Active hepatitis B or hepatitis C virus infection.\n4. Patients with HIV infection.\n5. Patients with positive Treponema pallidum.\n6. A history of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, coronary angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases.\n7. Tumor lesions invading the heart or major blood vessels.\n8. Abnormal pulmonary function indicated by a ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \\\u003C 70% in pulmonary function tests.\n9. A history of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disease, and organic brain syndrome.\n10. Use of the following drugs or treatments:\n\n    1. Hormones: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \\> 20 mg\u002Fday) within 72 hours prior to administration of the study drug; physiologic replacement doses, topical, and inhaled steroids are permitted;\n    2. Chemotherapy: Receipt of salvage chemotherapy within 2 weeks prior to administration of the study drug;\n    3. GvHD treatment: Receipt of anti-GvHD therapy within 4 weeks prior to administration of the study drug;\n    4. Allogeneic bone marrow transplantation;\n    5. Gene therapy;\n    6. Adoptive cell therapy;\n11. Females who are pregnant or breastfeeding.\n12. A history of primary immunodeficiency or autoimmune disease, except for the following:\n\n    * History of hypothyroidism with stable thyroid hormone replacement therapy;\n    * Patients with well-controlled type 1 diabetes mellitus.\n13. Patients whose disease or condition renders them unable to understand, participate in, and\u002For comply with the study protocol.\n14. Any other disease that the investigator believes would impair the subject's ability to tolerate protocol treatment or significantly increase the risk of complications.\n15. Current or past history of psychoactive substance abuse or dependence.\n16. Subjects whose underlying condition, in the investigator's judgment, may increase the risk of receiving the investigational drug or confound the interpretation of toxic reactions and adverse events.\n17. Other conditions deemed unsuitable for participation in the study by the investigator.\n\nScreening Period 2\n\nInclusion Criteria 2:\n\nThe patient's organ function and key test items at this stage should not have significant changes compared with their test results in Screening Period 1. If the patient's test results in Screening Period 2 exceed the following criteria, they should not receive administration of KXV01 Injection until the abnormal items return to the normal range.\n\n1. The patient's KXV01 Injection has been successfully prepared.\n2. Expected survival time \\> 6 months.\n3. ECOG performance status of 0 or 1.\n4. Sufficient organ function.\n5. Females of childbearing potential have a negative blood pregnancy test within 7 days prior to administration of the study drug (Non-childbearing potential: surgically sterilized or postmenopausal for at least 2 years). In addition, female subjects of childbearing potential must use medically approved contraceptive measures for 12 months after the start of study treatment and have no egg retrieval during this period.\n6. Male subjects are willing to use medically approved contraceptive measures from the time of signing the informed consent form until 12 months after the start of study treatment, and will not donate sperm during this period.\n7. At least one measurable lesion according to RECIST v1.1 criteria.\n8. Toxicities and adverse reactions caused by prior therapy should have resolved to Grade ≤ 1 (except for toxicities considered clinically insignificant, such as chemotherapy-induced alopecia).\n\nExclusion Criteria 2:\n\n1. Prior to administration of the study drug, the subject's anti-tumor therapy has not been sufficiently washed out (2 weeks or 5 half-lives, whichever is shorter):\n\n   Except for the following:\n   * Gonadotropin (GnRH) agonists or antagonists used for the treatment of prostate cancer\n   * Hormone replacement therapy, or oral contraceptives.\n2. Uncontrolled infectious diseases within the previous 4 weeks.\n3. Active hepatitis B or hepatitis C virus infection.\n4. Patients with HIV infection.\n5. Patients with positive Treponema pallidum.\n6. Tumor lesions invading the heart or major blood vessels.\n7. A history of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disease, and organic brain syndrome.\n8. Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases.\n9. Use of the following drugs or treatments between Screening Period 1 and Screening Period 2:\n\n   1. Hormones: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \\> 20 mg\u002Fday) within 72 hours prior to administration of the study drug; physiologic replacement doses, topical, and inhaled steroids are permitted;\n   2. Chemotherapy: Receipt of salvage chemotherapy within 2 weeks prior to administration of the study drug;\n   3. GvHD treatment: Receipt of anti-GvHD therapy within 4 weeks prior to administration of the study drug;\n   4. Allogeneic bone marrow transplantation;\n   5. Gene therapy;\n   6. Adoptive cell therapy;\n   7. Use of alemtuzumab within 6 months prior to administration of the study drug, or clofarabine or cladribine within 3 months prior to administration;\n   8. Receipt of radiotherapy between Screening Period 1 and Screening Period 2. Patients are eligible only if lesions within the radiation field show progressive disease (PD), or there are measurable lesions outside the radiation field meeting RECIST v1.1 criteria on imaging assessment; if there are measurable lesions outside the radiation field, radiotherapy to other lesions must be at least 2 weeks apart from the administration date of the study drug.\n10. Females who are pregnant or breastfeeding.\n11. Subjects whose underlying condition, in the investigator's judgment, may increase the risk of receiving the investigational drug or confound the interpretation of toxic reactions and adverse events.\n12. Receipt of major surgery (excluding diagnostic surgery) between Screening Period 1 and Screening Period 2, or expected to undergo major surgery during the study period. Subjects with planned or ongoing minor surgical procedures (such as venous access placement, etc.) are eligible for enrollment.","70 Years",{"count":122,"type":20},30,[23],"This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KXV01 TCR Lentinvivo for patients with advanced solid tumors.",[26],"NOT_YET_RECRUITING","2025-09-20",{"date":129,"type":32},"2025-09-29",{"date":131,"type":20},"2025-10-01",{"date":133,"type":20},"2028-12-31",{"name":135,"class":39},"TCRx Therapeutics Co.Ltd",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":62},"100591817","phase-1-a-study-of-mhb046c-injection-in-patients-with-advanced-solid-tumors-100591817","NCT06985355","A Study of MHB046C Injection in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB046C Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the study and signs the informed consent form.\n2. Age ≥ 18 years, no restriction on gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Estimated life expectancy ≥ 3 months.\n5. Able to understand and comply with the study protocol and follow-up procedures.\n6. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.\n7. At least one measurable lesion per RECIST v1.1 criteria.\n8. Adequate organ function.\n\nExclusion Criteria:\n\n1. History of ≥2 primary malignancies within 5 years prior to informed consent.\n2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.\n3. Brain metastases (unless asymptomatic, no edema, stable ≥4 weeks without steroids), leptomeningeal disease, brainstem metastases, or spinal cord compression.\n4. Severe lung disease affecting pulmonary function.\n5. Active systemic infection requiring treatment within 7 days before dosing.\n6. Serious cardiovascular or cerebrovascular diseases\n7. Uncontrolled third-space effusions not suitable for enrollment:\n8. Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months.\n9. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.\n10. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.\n11. Drug abuse or other medical\u002Fpsychiatric condition that may interfere with study participation or results.\n12. Known alcohol or drug dependence.\n13. Pregnant or breastfeeding women, or individuals planning to conceive.",{"count":144,"type":20},200,[23,146],"PHASE2","This is a first-in-human, open-label, multicenter Phase I\u002FII study of MHB046C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB046C monotherapy.",[26],"2025-09-16",{"date":151,"type":32},"2025-09-18",{"date":153,"type":32},"2025-07-17",{"date":155,"type":20},"2031-05",{"name":157,"class":39},"Minghui Pharmaceutical (Hangzhou) Ltd",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100599753","phase-1-study-of-syn608-for-the-treatment-of-advanced-or-metastatic-solid-tumors-100599753","NCT07088588","Study of SYN608 for the Treatment of Advanced or Metastatic Solid Tumors","A First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYN608, a Poly ADP-ribose Glycohydrolase (PARG) Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Having signed the written Informed Consent Form (ICF);\n* Male or female aged ≥18 years;\n* Life expectancy ≥12 weeks;\n* Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;\n* Patients with histologically or cytologically confirmed locally advanced or metastatic breast cancer, ovarian cancer or other advanced solid tumors who have experienced disease progression, and available standard of care (SOC) therapies had been exhausted;\n* be willing to provide tumor tissue samples (fresh frozen \\[SF\\] or previously retained paraffin-embedded \\[FFPE\\] tumor tissue samples) or peripheral blood germline DNA or ctDNA sample to detect BRCA mutation, or other deficiency in the Homologous Recombination (HR) pathway (by the detection method of next generation sequencing \\[NGS\\])\n* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;\n* No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease;\n* Adequate organ function and bone marrow function.\n\nExclusion Criteria:\n\n* Previous or current use of Poly (ADP) ribose glycohydrolase (PARG) inhibitors;\n* Serious allergy to the study drug or any of its excipients;\n* Current or previous other malignancy unless treated radically and with no evidence of recurrence or metastasis within the past 5 years;\n* Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;\n* Patients with Myelodysplastic syndrome (MDS)\u002FAcute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML;\n* Dysphagia or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunts, or gastrointestinal disorders that affect drug absorption, e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome, or other malabsorption conditions;\n* Treatment with an anti-cancer small molecule within 5 half-lives (t1\u002F2), or 2 weeks, whichever is shorter;\n* History of use within 2 weeks prior to the first dose of the study treatment and need to use protocol-prohibited potent inhibitors or potent inducers of cytochrome P450 (CYP) 3A4\u002FBCRP\u002FP-gp during the study;\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease;\n* Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.",{"count":166,"type":20},105,[23],"This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN608 as monotherapy in adult patients with advanced solid tumors",[26,170,171,172,173,174],"Metastatic Solid Tumor","Ovarian Cancer","Breast Cancer","BRCA Mutation","HRR Deficiency","2025-07-25",{"date":177,"type":32},"2025-07-28",{"date":179,"type":20},"2025-07-31",{"date":181,"type":20},"2028-10-31",{"name":183,"class":39},"Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd",2,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":184},"100567290","phase-1-study-of-syn818-for-the-treatment-of-advanced-or-metastatic-solid-tumors-100567290","NCT06666270","Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors","A First-in-human, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of SYN818, a DNA Polymerase Theta (POLQ) Inhibitor Alone in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Having signed the written Informed Consent Form (ICF);\n* Male or female aged ≥18 years;\n* Life expectancy ≥12 weeks;\n* Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1;\n* Patients with histologically or cytologically confirmed locally advanced or metastatic breast cancer, ovarian cancer, prostate cancer or other advanced solid tumors who have experienced disease progression, and available SOC therapies had been exhausted;\n* be willing to provide tumor tissue samples (fresh frozen \\[SF\\] or previously retained paraffin-embedded \\[FFPE\\] tumor tissue samples) or peripheral blood germline DNA or ctDNA sample to detect BRCA mutation, or other deficiency in the HR pathway (by the detection method of next generation sequencing \\[NGS\\])\n* At least one measurable lesion according to RECIST v1.1;\n* No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease;\n* Adequate organ function and bone marrow function.\n\nExclusion Criteria:\n\n* Previous or current use of POLQ inhibitors;\n* Hypersensitivity to the active pharmaceutical ingredient or any excipient of SYN818;\n* Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled;\n* Other malignant tumors than the study tumors within 5 years prior to the first dose of the study drug, except for localized cancers that have been evidently cured or disease-free for at least 3 years, such as basal or squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, carcinoma in situ of cervix, or carcinoma in situ of breast;\n* Patients with Myelodysplastic syndrome (MDS)\u002FAcute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML;\n* Dysphagia or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunts, or gastrointestinal disorders that affect drug absorption, e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome, or other malabsorption conditions;\n* Major surgery or serious trauma within 4 weeks prior to the first dose of the study treatment or major surgery planned during the trial period, and none of the AEs related to surgery or major trauma have resolved (to ≤ CTCAE v5.0 Grade 1 or baseline level) before the first dose of the study drug;\n* History of use within 2 weeks prior to the first dose of the study treatment and need to use protocol-prohibited potent inhibitors or potent inducers of cytochrome P450 (CYP) 3A4\u002FBCRP\u002FP-gp during the study;\n* Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.",{"count":122,"type":20},[23],"This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors",[26,170,171,172,196,173,174],"Prostate Cancer","2025-07-18",{"date":199,"type":32},"2025-07-20",{"date":201,"type":32},"2024-11-21",{"date":203,"type":20},"2026-12-30",{"name":183,"class":39},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":5},"100356134","phase-1-apg-2449-in-patients-with-advanced-solid-tumors-100356134","NCT03917043","APG-2449 in Patients With Advanced Solid Tumors","A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Orally Administered APG-2449 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Dose exploration stage: non-small cell lung cancer diagnosed by histology and\u002For cytology and positive for ALK\u002FROS1 gene fusion (molecular diagnosis confirmed by the investigator) and malignant pleural mesothelioma, esophageal cancer and ovarian cancer. Kind of patients with advanced tumors.\n\n   Expansion stage: cohort 1, patients with non-small cell lung cancer who have progressed or are intolerant to TKI therapy, including patients with second-generation ALK TKI, or either ROS1 TKI, or third-generation ALK inhibitor (lorlatinib, etc.) with pFAK expression (pFAK expression is subject to central laboratory results) of about 10 or above; Cohort 2, TKI-naïve patients with ALK\u002FROS1 fusion gene positive NSCLC. The molecular diagnosis results of the above patients can be confirmed by the investigator.\n2. ECOG Performance Status ≤ 1.\n3. Expectation of life ≥ 3 months.\n4. According to RECIST version 1.1, there is at least 1 measurable lesion.\n5. Adequate hematologic and bone marrow functions.\n6. Adequate renal and liver function.\n7. Normal cardiac function.\n8. Brain metastases with clinically controlled neurologic symptoms.\n9. Serum pregnancy test results of women of childbearing age were negative within 7 days before taking the first dose of study drug.\n10. Men, women of childbearing age (postmenopausal women must have been menopausal for at least 12 months before they can be considered infertile) and their partners voluntarily take the study drug for at least 30 days after signing the informed consent form and taking the study drug as deemed effective by the investigator Contraceptive measures\n11. Ability to understand and willingness to sign a written informed consent form\n12. Subjects must be willing and able to complete the research procedures and follow-up inspections.\n13. Subjects are required to provide fresh (for recurrent subjects only) or archived tumor tissue samples from within 28 days prior to treatment. If none of these specimens are available, they may be included after consultation with the sponsor.\n14. Subjects should provide fresh biopsy tumor tissue specimens prior to treatment.\n\nExclusion Criteria:\n\n1. Receiving concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy); or any investigational therapy within 28 days prior to the first dose of study drug.\n2. Receiving TKI therapy within 8 days prior to the first dose of study drug.\n3. Continuance of toxicities due to prior therapy that do not recover (CTCAE V5.0 Grade\\> 1).\n4. Has difficulty in swallowing, absorbing barrier, or other diseases blocking APG-2449' taken.\n5. Obvious cardiovascular disease history.\n6. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.\n7. Active symptomatic fungal, bacterial and\u002For viral infection including, but not limited to, active human immunodeficiency virus (HIV) or viral hepatitis (B or C).\n8. Known allergies to study drug ingredients or their analogs.\n9. Female subjects who are pregnant or breastfeeding, or expecting to become pregnant during the study period.\n10. According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may endanger its safety or interfere with the safety assessment of the study drug.\n11. Subjects who have used CYP3A4, CYP2C9, or CYP2C19 moderately potent inhibitors or moderately potent inducers 1 week before receiving the study drug for the first time.\n12. Subjects who used CYP3A4 substrates and narrow treatment window 1 week before the first study drug.",{"count":213,"type":20},165,[23],"APG-2449 is a novel, orally active, multi-targeted tyrosine kinase inhibitor, which inhibits FAK, ALK, and ROS1 with nanomolar potencies. In preclinical studies, APG-2449 demonstrated potent antiproliferative activity in various cancer cell lines as a single agent. In combination treatment, APG-2449 enhanced anti-proliferative activities of several chemotherapeutic and targeted agents. It is indicated that APG-2449 may have a broad therapeutic potential for the treatment of human cancer as a single agent and in combination with other classes of anticancer drugs. APG-2449 is intended for the treatment of patients with advanced solid tumors. Upon completion of the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and\u002For recommended phase 2 dose (RP2D), several phase Ib\u002FII studies will be implemented accordingly.",[26,217,218,171,219],"Non Small Cell Lung Cancer","Esophageal Cancer","Malignant Pleural Mesothelioma","2025-06-16",{"date":222,"type":32},"2025-06-18",{"date":224,"type":32},"2019-05-27",{"date":226,"type":20},"2028-01",{"name":228,"class":39},"Ascentage Pharma Group Inc."]