[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-unresectable-or-metastatic-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-unresectable-or-metastatic-solid-tumors":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,43,66,95,118,141,172],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100642580","phase-2-ssgj-705-plus-ssgj-612--chemotherapy-in-advanced-her2-expressing-solid-tumors-100642580",false,"NCT07646626","SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors","A Phase II Study of SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors","Inclusion Criteria:\n\n* Males and\u002For females over age 18\n* Histologically and\u002For cytologically documented local advanced or metastatic Colorectal adenocarcinoma (CRC), Urothelial Cancer (UC), Breast Cancer (BC), Biliary Tract Carcinoma(BTC), Gastric\u002FGastroesophageal Junction Cancer （G\u002FGEJC) , etc.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Expected survival \\>3 months.\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Any remaining adverse events (AEs) \\> grade 1 from prior anti-tumor treatment as per Common Terminology Criteria for Adverse Events（CTCAE） v6. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.\n* Pregnant or nursing women or women\u002Fmen who are ready to give birth\n* symptomatic central nervous system metastasis.\n* Allergy to other antibody drugs or any excipients in the study drugs.\n* Inadequate organ or bone marrow function. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","18 Years","75 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study was an open-label phase Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Plus SSGJ-612 ± Chemotherapy in patients with advanced HER2-Expressing Solid Tumors.",[27],"Locally Advanced (Unresectable) or Metastatic Solid Tumors",[29],"advanced malignancies","RECRUITING","2026-06-08",{"date":33,"type":34},"2026-06-15","ACTUAL",{"date":36,"type":21},"2026-07-31",{"date":38,"type":21},"2028-10-31",{"name":40,"class":41},"Shenyang Sunshine Pharmaceutical Co., LTD.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100640517","phase-1-a-study-of-neok002-an-egfr-and-muc1-targeting-bispecific-adc-in-participants-with-select-solid-tumors-100640517","NCT07612189","A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific ADC, in Participants With Select Solid Tumors","A Study of NEOK002, an EGFR and MUC1 Targeting Bispecific Antibody-Drug, Conjugate in Participants With Select Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Participants must have locally advanced or metatstatic disease in a select tumor type, for which no standard therapy is available.\n* Participants must have at least 1 measurable target lesion based on RECIST v1.1.\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate hematologic, hepatic, and renal function.\n* Participants should have available archived tumor tissue from their most recent biopsy.\n\nKey Exclusion Criteria:\n\n* Participant's most recent systemic anti-cancer treatment was an ADC with a topoisomerase 1-inhibitor payload component.\n* Participant with known symptomatic central nervous system (CNS) metastases or any evidence of leptomeningeal disease or evidence of unstable CNS metastases, even if asymptomatic.\n* Participants with a known history of interstitial lung disease (ILD) requiring steroid treatment, or for whom suspected ILD cannot be ruled out by imaging at screening.\n* Participants with clinically severe pulmonary compromise due to intercurrent pulmonary illness and\u002For pulmonary disorder requiring supplemental oxygen or any prior pneumonectomy.\n* Participants with a QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec.",{"count":51,"type":21},155,[53],"PHASE1","This is a first in human (FIH), Phase 1 dose escalation and expansion study in select solid tumors. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B).",[27],"2026-05-28",{"date":58,"type":34},"2026-06-01",{"date":60,"type":34},"2026-04-22",{"date":62,"type":21},"2029-02",{"name":64,"class":41},"NEOK Bio, Inc.",8,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":65},"100640013","phase-1-a-phase-1-study-of-neok001-a-b7-h3-and-ror1-targeting-bispecific-adc-in-participants-with-select-solid-tumors-100640013","NCT07612176","A Phase 1 Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific ADC in Participants With Select Solid Tumors","A Phase 1 Dose Escalation and Expansion Study of NEOK001, a B7-H3 and ROR1 Targeting Bispecific Antibody-Drug Conjugate, in Participants With Select, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Participants must have locally advanced or metastatic disease in a select tumor type, for which no standard therapy is available.\n* Participants must have at least 1 measurable target lesion based on RECIST v1.1.\n* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate hematologic, hepatic, and renal function.\n* Participants should have available archived tumor tissue from their most recent biopsy.\n\nKey Exclusion Criteria:\n\n* Participant's most recent systemic anti-cancer treatment was an ADC with a topoisomerase 1-inhibitor payload component.\n* Participants with known symptomatic central nervous system (CNS) metastases or any evidence of leptomeningeal disease or evidence of unstable CNS metastases, even if asymptomatic.\n* Participants with a known history of interstitial lung disease (ILD) requiring steroid treatment, or for whom suspected ILD cannot be ruled out by imaging at screening.\n* Participants with clinically severe pulmonary compromise due to intercurrent pulmonary illness and\u002For pulmonary disorder requiring supplemental oxygen or any prior pneumonectomy.\n* Participants with a QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msec.",{"count":51,"type":21},[53],"This is a first in human (FIH), Phase 1, dose escalation and expansion study in select solid tumors. This study includes 2 parts: a Dose Escalation and Backfill portion (Part A) and a Dose Expansion portion (Part B).",[27],[78,79,80,81,82,83,84,85,86,87],"Antibody-Drug Conjugate","ADC","Bispecific","B7-H3","ROR1","Locally Advanced","Unresectable","Metastatic","Solid Tumor","oncology","2026-05-21",{"date":56,"type":34},{"date":91,"type":34},"2026-04-21",{"date":93,"type":21},"2029-01",{"name":64,"class":41},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100474462","phase-1-a-first-in-human-study-of-ibi343-in-subjects-with-locally-advanced-unresectable-or-metastatic-solid-tumors-100474462","NCT05458219","A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors","A Phase 1a\u002Fb, Multicenter, Open-label, First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors","Inclusion Criteria:\n\nInclusion criteria to be met for both Phase Ia and Phase Ib:\n\n1. Has signed written Informed Consent Form (ICF), willing and able to comply with protocol-specified visits and related procedures.\n2. Phase Ia dose escalation phase, Phase Ia part 3 1L G\u002FGEJ AC and 1L PDAC cohorts Safety Lead-in stage: Has at least 1 evaluable lesion according to RECIST v1.1; Phase Ia dose expansion and dose optimization phase, Phase Ia part 3 1L G\u002FGEJ AC and 1L PDAC cohorts Dose optimization stage, Phase Ib: Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors RECIST v1.1.\n3. Age ≥ 18 years, of either sex.\n4. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n5. Has an expected survival ≥ 12 weeks.\n6. Has adequate bone marrow and organ function. Defined as:\n\n   • Hematology: ANC ≥ 1.5 × 109\u002FL; Platelet count ≥ 100 × 109\u002FL; Hemoglobin ≥ 9.0 g\u002FdL, participants must not have received transfusion of blood products (including red blood cell suspension, apheresis platelets, cryoprecipitate, etc.), erythropoietin (EPO), G-colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) within 7 days prior to blood sample collection;\n   * Hepatic function: TBIL ≤ 1.5 × ULN (TBIL ≤ 3 × ULN is allowed for participants with Gilbert's syndrome); ALT and AST ≤ 2.5 × ULN for participants without liver metastasis and ≤ 5 × ULN for participants with liver metastasis; Albumin ≥ 28 g\u002FL;\n   * Renal function: estimated creatinine clearance ≥ 30mL\u002Fmin (using Appendix 5. Calculation of Estimated Creatinine Clearance and Body Surface ).\n   * Coagulation function: international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (participants receiving anticoagulant therapy with coagulation function within the above range are allowed).\n7. Female participants of childbearing potential or male participants whose partners are female of childbearing potential are required to use effective contraceptive measures throughout the treatment period and for 6 months after the final treatment period.\n\nInclusion Criteria for Phase Ia Dose Escalation:\n\n1. Participants with histopathologically confirmed unresectable locally advanced or metastatic malignant solid tumors that have failed or were intolerant to standard therapy or for whom no standard therapy is available.\n\nInclusion Criteria for Phase Ia Dose Expansion, Dose Optimization :\n\n1. Participants with histopathologically confirmed unresectable locally advanced or metastatic G\u002FGEJ AC, PDAC, BTC, or other solid tumors who have failed or were intolerant to standard therapy or for which no standard therapy is available.\n2. \\* CLDN18.2-positive confirmed by pathological examination (in dose expansion phase, G\u002FGEJ AC and PDAC preferentially enrolled \\*\\*\\* moderate to high expression of CLDN18. 2; in dose optimization phase , G\u002FGEJ AC preferentially enrolled \\*\\*high expression of CLDN18.2 and PDAC preferentially enrolled \\*\\*\\*moderate to high expression of CLDN18.2). For participants with previous anti-CLDN18.2 treatment (including but not limited to monoclonal antibodies, ADCs, CAR-T, etc.), tumor samples should be obtained post anti-CLDN18.2 therapy for CLDN18.2 expression evaluation.\n\nInclusion Criteria for Phase Ia Part 3 1L G\u002FGEJ AC Cohort:\n\n1. Participants with histopathologically confirmed unresectable locally advanced or metastatic G\u002FGEJ AC who has not received previous systemic therapy. (For Safety Lead-in stage, participants who has received previous systemic therapy are permitted.) A prior (neo)adjuvant systemic therapy completed within 6 months prior to disease relapse or progression will be considered as having received previous systemic therapy.\n2. Confirmed Her 2-negative (defined as IHC 0 or 1+, or IHC 2+ and negative by in situ hybridization) disease.\n3. Confirmed combined positive score (CPS) \\\u003C5 as determined by local IHC testing.\n4. Participants must not have previously received topoisomerase inhibitor-based antibody-drug conjugate(s), unless given peri-operatively without evidence of resistance.\n5. Participants must not have previously received anti-CLDN18.2 therapy.\n6. \\*CLDN18.2-positive confirmed by pathological examination by central laboratory (For Dose optimization stage, G\u002FGEJ AC enrolled participants with Claudin18.2 immunohistochemical membrane staining intensity 2+\u002F3+ in ≥50% of tumor cells).\n\nInclusion Criteria for Phase Ia Part 3 1L PDAC Cohort:\n\n1. Participants with histopathologically confirmed metastatic PDAC who has not received previous systemic therapy in the metastatic setting. (For Safety Lead-in stage, participants who has received previous systemic therapy are permitted.) A prior (neo)adjuvant systemic therapy completed within 12 months prior to disease relapse or progression will be considered as having received previous systemic therapy.\n2. Participants must not have previously received anti-CLDN18.2 therapy.\n3. Participants must not have previously received topoisomerase inhibitor-based antibody-drug conjugate(s), unless given peri-operatively without evidence of resistance.\n4. \\*CLDN18.2-positive confirmed by pathological examination by central laboratory (For Dose optimization stage, PDAC enrolled # specified expression of CLDN 18.2)\n\nInclusion Criteria for Phase Ib Cohort A:\n\n1. Histopathologically confirmed unresectable locally advanced or metastatic G\u002FGEJ AC.\n2. Have received at least 2 lines of systemic therapy \\[anti-PD-(L)1 + platinum, fluoropyrimidines, paclitaxel\u002Fdocetaxel, or irinotecan; participants with HER2 overexpression (defined as 3 + or 2 + by immunohistochemistry and ISH +) must have received anti-HER2 therapy, and participants who have not received prior anti-PD-(L)1 or anti-HER2 therapy must have had a contraindication or reasonable reason for no benefit\\] and have had disease progression.\n3. High expression of \\*\\*CLDN18. 2 was confirmed by pathological examination.\n\nInclusion Criteria for Phase Ib Cohort B:\n\n1. Histopathologically confirmed unresectable locally advanced or metastatic G\u002FGEJ AC.\n2. Disease progression after first-line standard therapy (HER2-overexpressing participants must have received prior anti-HER2 therapy unless contraindicated or justified non-benefit).\n3. Confirmed \\* CLDN18.2-positive by histopathological examination.\n\nInclusion Criteria for Phase Ib Cohort C:\n\n1. Histopathologically confirmed unresectable locally advanced or metastatic PDAC.\n2. Disease progression after at least one prior systemic therapy.\n\nInclusion criteria for Phase Ib Cohort D:\n\n1. Histopathologically confirmed unresectable locally advanced or metastatic BTC.\n2. Disease progression after at least one prior systemic therapy.\n3. Confirmed \\* CLDN18.2-positive by histopathological examination.\n\nNotes:\n\n* CLDN18.2-positive: defined as ≥ 1% of tumor cells with membranous staining of any intensity in tumor tissue by immunohistochemistry, when tested previously, at the study site, or at the central laboratory.\n\n  * High expression of CLDN18. 2: Claudin18.2 immunohistochemical membrane staining intensity ≥ 2 + in ≥ 75% of tumor cells.\n\n    * Moderate to high expression of CLDN18.2: Claudin18.2 immunohistochemical membrane staining intensity ≥ 2 + in ≥ 40% of tumor cells.\n\n      * Specified expression of CLDN18.2: Claudin18.2 immunohistochemical membrane staining intensity 1+\u002F2+\u002F3+ in ≥50% of tumor cells.\n\nExclusion Criteria:\n\nExclusion criteria common to Phases Ia and Ib:\n\n1. Is participating in another interventional clinical study other than an observational (non-interventional) clinical study or is in the survival follow-up phase of an interventional study.\n2. Has received the last dose of antineoplastic therapy within 4 weeks or 5 half-lives of an antineoplastic therapy (whichever is shorter) prior to the first dose of study drug.\n3. Plans to receive other anti-tumor therapy during treatment with the study drug \\[palliative radiotherapy for symptomatic relief (e.g., pain) that does not affect response assessment is allowed\\].\n4. Has received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n5. Toxicities due to prior therapy that have not recovered to Grade 0 or 1 per NCI CTCAE v5.0 prior to the first dose of study drug (excluding alopecia, asthenia, hyperpigmentation, and other conditions with no safety risk per the judgment of the investigator).\n6. Has undergone major surgical procedure (craniotomy, thoracotomy, laparotomy or others per the investigator, excluding needle biopsy) or has unhealed wounds, ulcers, or bone fracture within 4 weeks prior to the first dose of study drug; Or plans to undergo major surgery during the study period; Note: Local surgical treatment of isolated lesions for palliative purposes is acceptable.\n7. Has gastric pyloric obstruction and\u002For persistent recurrent vomiting (≥ 3 episodes in 24 hours).\n8. Has a history of gastrointestinal perforation and\u002For fistula within 6 months that has not resolved surgically prior to the first dose of study drug.\n9. Has symptomatic central nervous system metastases. Participants with asymptomatic brain metastases (i.e., no neurological symptoms, no need for glucocorticoid treatment, all brain metastasis ≤ 1. 5 cm) or stable symptoms after treatment of brain metastases must meet all of the following criteria to participate in the study: no metastasis in the midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord; Stable clinical status for at least 4 weeks with definitive clinical evidence of no new or enlarging brain metastasis and discontinuation of corticosteroids and anticonvulsants for at least 2 weeks prior to the first dose of study drug. Note: lesions of the central nervous system will not be considered as a target lesion\n10. Has a history of pneumonitis requiring corticosteroids therapy, or a history of interstitial lung disease, non-infectious pneumonitis, severely impaired lung function or uncontrolled lung disease, such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, or suspected of having the above diseases during the screening period.\n11. Has uncontrolled medical conditions, such as:\n12. Active or clinically uncontrolled serious infection requiring treatment with systemic anti-infectives (antibiotics, antivirals, or antifungals) within 1 week prior to the first dose of study drug, including but not limited to the infection of respiratory tract, urinary system, biliary tract infection, etc.\n13. Participants infected with human immunodeficiency virus (HIV) (HIV 1\u002F2 antibody positive).\n14. Acute or chronic active hepatitis B (defined as hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody positive (HBcAb) with hepatitis B virus DNA copies ≥ 104 copies\u002FmL or ≥ 2000 IU\u002FmL or above the lower limit of detection) or acute or chronic active hepatitis C \\[hepatitis C virus antibody (HCVAb) positive with HCV RNA \\> 103 copies\u002FmL\\]. Participants whose test results are below the above criteria after receiving antiviral therapy with nucleotides, or participants with positive serology but negative HCV-RNA test result are eligible.\n15. Has active pulmonary tuberculosis, is being treated with anti-tuberculosis therapy or having received anti-tuberculosis therapy within 1 year prior to the first dose of study drug.\n16. Has active syphilis or latent syphilis requiring treatment.\n17. Has symptomatic congestive heart failure (New York Heart Association classification NYHA class II-IV), symptomatic or uncontrolled arrhythmia, QTc interval \\> 480 ms, or personal or family history of congenital long\u002Fshort QT syndrome.\n\n    For part 3 1L G\u002FGEJ AC and 1L PDAC cohort, the QTc should be calculated based on the average of triplicate screening ECG (using Appendix 4 Calculation Formula of QTcF)\n18. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) by standard treatment.\n19. Has one or more arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, etc., within 6 months prior to the first dose of study drug.\n20. Has received stent implantation in tracheal or digestive tract.\n21. Has symptomatic pleural, ascites, or pericardial effusion requiring intervention (e.g., drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy \\[CART\\]). Asymptomatic participants with a small amount of pleural effusion, ascites or pericardial effusion on imaging are allowed. (Drainage and CART are not allowed within 2 weeks prior to screening assessment).\n22. Has esophageal or gastric varices that require immediate intervention (e.g., ligature or sclerotherapy) or are considered to be at high risk for bleeding in the opinion of the investigator or consulting gastroenterologist or hepatologist. Participants with evidence of portal hypertension (including splenomegaly on imaging) or a history of prior variceal bleeding must undergo endoscopic evaluation within 3 months prior to the first dose of study drug.\n23. Has one or more life-threatening bleeding event or Grade 3 or 4 gastrointestinal\u002Fvariceal bleeding requiring blood transfusion, endoscopic or surgical treatment within 3 months prior to the first dose of study drug\n24. Has a history of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug (implantable venous access port or catheter-derived thrombosis, or superficial vein thrombosis is not considered \"serious\" venous thromboembolism).\n25. Has hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh B or more severe cirrhosis.\n26. Has complete or incomplete intestinal or bowel obstruction at the time of screening or a history of complete or incomplete intestinal or bowel obstruction within 3 months prior to first dose, or is at risk of intestinal perforation (including but not limited to acute diverticulitis, history of intra-abdominal abscess), or a history of any of the following disease: inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection with concurrent chronic diarrhea), Crohn's disease, ulcerative colitis, and chronic diarrhea.\n27. Has other acute or chronic disease or laboratory abnormality that may result in increased risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and is considered unfit for this study per the Investigator's judgement.\n28. Has a neurological or psychiatric illness or a social situation that affects compliance with study requirements, significantly increases the risk of AE, or affects the participant's ability to provide written ICF.\n29. Has a history of other primary malignancies, with the following exceptions:\n30. Curatively treated malignancy with no known active disease for ≥ 2 years prior to study enrollment and is at minimal risk of recurrence;\n31. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease recurrence;\n32. Adequately treated carcinoma in situ with no evidence of disease recurrence.\n33. Has a known history of immunodeficiency.\n34. Has a history of allogeneic organ transplantation and history of allogeneic hematopoietic stem cell transplantation.\n35. Has a history of severe allergic reaction to other monoclonal antibodies and\u002For hypersensitivity to any of the formulation components of IBI343 or mFOLFOX or Irinotecan or liposomal Irinotecan (For phase 1a part 3 1L G\u002FGEJ AC and 1L PDAC cohort).\n36. Female participants who are pregnant or lactating.\n37. Has other conditions considered not eligible to participate in this study per the Investigator's judgement.\n38. Has known dihydropyrimidine dehydrogenase deficiency (DPD). (NOTE: Screening for DPD deficiency should be conducted per local requirements.)\n39. Has known peripheral sensory neuropathy \\> grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.",{"count":103,"type":21},470,[53],"This is a Phase Ia\u002FIb, multicenter, open-label, first-in-human study to evaluate the safety, tolerability, PK, and efficacy of IBI343 in participants with locally advanced unresectable or metastatic solid tumors. It is planned to be carried out in different countries or regions such as China, Australia and US.\n\nThere are three parts in phase Ia. Part 1 includes dose escalation and expansion phase and part 2 is designed for dose optimization for IBI343 monotherapy.\n\nPart 3 1L G\u002FGEJ AC and 1L PDAC cohorts will include an initial safety lead-in stage to confirm the tolerability of IBI343 in combination with chemotherapy in 1L PDAC and G\u002FGEJ AC, followed by a randomized dose-optimization stage designed to further characterize safety, pharmacokinetics, and preliminary efficacy to inform selection of the recommended Phase 3 dose.",[107],"Locally Advanced Unresectable or Metastatic Solid Tumors","2026-04-28",{"date":110,"type":34},"2026-05-04",{"date":112,"type":34},"2022-10-26",{"date":114,"type":21},"2027-12-31",{"name":116,"class":41},"Innovent Biologics (Suzhou) Co. Ltd.",39,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100505129","phase-1-sg1906-for-cldn182-positive-solid-tumors-100505129","NCT05857332","SG1906 for CLDN18.2-Positive Solid Tumors","A Phase Ia\u002FIb Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG1906 in Patients With CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Solid Tumors.","CSG-1906-101","Inclusion Criteria:\n\n* Patients must meet all the following criteria to be eligible for participation in this study:\n\n  1. Understand and voluntarily sign the informed consent form (ICF).\n  2. Age ≥18 years.\n  3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n  4. Expected survival time of ≥3 months.\n  5. Able to provide tumor tissue samples for CLDN18.2 detection.\n  6. Specific requirements for patients enrolled in Phase Ia and Phase Ib are as follows:\n\n     Phase Ia Dose Escalation Phase\n     1. Patients with CLDN18.2-positive histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor who have relapsed after standard therapy, have failed standard therapy, are intolerant to standard therapy, are not eligible for standard therapy, or refuse standard therapy.\n     2. CLDN18.2 positivity is defined as H score ≥1 by central laboratory immunohistochemistry.\n\n     Phase Ib Dose Expansion Stage\n     1. Patients with histologically or cytologically confirmed CLDN18.2-positive locally advanced unresectable or metastatic G\u002FGEJ adenocarcinoma or pancreatic cancer who have failed to respond to standard therapy, have relapsed after standard therapy, or are intolerant to standard therapy.\n     2. CLDN18.2 positivity is defined as H score ≥40 by central laboratory immunohistochemistry.\n  7. At least one evaluable lesion (refer to Response Evaluation Criteria in Solid Tumors, version 1.1 \\[RECIST 1.1\\]).\n  8. Adequate function of vital organs, defined as follows:\n\n     1. Bone marrow function (no transfusion, erythropoietin, granulocyte colony-stimulating factor, or other medically supportive therapy within 7 days prior to the first dose): neutrophil count ≥1.5 × 109\u002FL, platelet count ≥100 × 109\u002FL, and hemoglobin level ≥10.0 g\u002FdL.\n     2. Adequate liver function, which must meet all of the following criteria:\n\n        * Serum total bilirubin ≤1.5 × upper limit of normal (ULN).\n        * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (AST and ALT ≤5 × ULN in patients with liver metastases).\n        * Albumin ≥3.0 g\u002FL.\n     3. Renal function: serum creatinine ≤1.5 × ULN or endogenous creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula).\n     4. Coagulation: international normalized ratio ≤1.5 × ULN or prothrombin time ≤1.5 × ULN, activated partial thromboplastin time ≤1.5 × ULN without receiving anticoagulation therapy.\n  9. Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0), except for alopecia, Grade ≤2 sensory neuropathy, lymphocytopenia, and endocrine disorders controlled with hormone replacement therapy.\n  10. Female patients of childbearing potential and male patients whose female partners are of childbearing potential need to use at least one approved contraceptive (e.g., intrauterine device, pill, or condom) during study treatment and for at least 6 months (180 days) after the last dose; female patients of childbearing potential must have a negative blood human chorionic gonadotropin (HCG) test within 7 days prior to dosing and must not be lactating.\n  11. Male patients must refrain from donating sperm from the time the ICF is signed until at least 6 months after the last dose.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria cannot be enrolled:\n\n1. Presence of active central nervous system metastatic lesions; presence of metastases to the brainstem or meninges, spinal cord metastases or compression. Exception: patients with previously treated brain metastases (e.g., surgery, radiation therapy) who are clinically stable for at least 4 weeks after treatment (calculated from the first dose of investigational drug) and have discontinued corticosteroids for ≥14 days prior to the administration of investigational drug; patients with untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no need for corticosteroids, brain metastases ≤1.5 cm in length, no significant edema around the brain metastases).\n2. Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., use of immunomodulatory drugs, corticosteroids, or immunosuppressive medications); related replacement therapy is allowed (e.g., thyroid hormone, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency).\n3. Pyloric obstruction or any other condition that can cause long-term chronic nausea, persistent recurrent vomiting (≥3 vomit episodes in 24 hours) or diarrhea.\n4. Patients who have recently developed gastrointestinal bleeding (i.e., a history of hematemesis, hematochezia, or melena within the past 3 months) without evidence of recovery confirmed by endoscopy or colonoscopy; or patients with evidence of risk of gastric bleeding.\n5. Patients with active gastrointestinal disease including, but not limited to, gastric or duodenal ulcers, acute gastric or intestinal perforation, acute necrotizing pancreatitis, ulcerative enteritis, congenital megacolon or Crohn's disease.\n6. Patients requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs); patients who are using anticoagulants such as heparin at therapeutic doses or vitamin K antagonists (except for prophylaxis).\n7. Presence of body fluid (hydrothorax, ascites, pericardial effusion, etc.) requiring local treatment or repeated drainage.\n8. Unintentional weight loss ≥5% within 1 month prior to initial dose, even with peripheral or central intravenous nutritional support.\n9. History of hemolytic anemia from any cause (including Evans syndrome).\n10. History of defects in red blood cell production, hemoglobin production, or metabolism, such as glucose-6-phosphate dehydrogenase deficiency, thalassemia, sickle cell disease, and hereditary spherocytosis.\n11. History of hemophagocytic lymphohistiocytosis.\n12. Presence of active infection requiring antibiotic therapy within 2 weeks prior to the first dose, except for prophylaxis.\n13. Presence of cardiovascular system disease within 6 months prior to screening that meets any of the following:\n\n    1. Cardiac function: congestive heart failure of New York Heart Association (NYHA) class III or IV; left ventricular ejection fraction \\\u003C50%.\n    2. Clinically significant cardiac disease or surgery within 6 months prior to the first dose of the investigational drug, including myocardial infarction, unstable angina pectoris, cerebrovascular accident, coronary\u002Fperipheral artery bypass, etc.\n    3. QTcF (corrected QT interval with Fridericia formula) \\>450 ms in men and \\>470 ms in women; history of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, tip-twist ventricular tachycardia); history or family history of congenital long QT syndrome; arrhythmias requiring antiarrhythmic drug therapy (patients with atrial fibrillation with controllable heart rate 1 month prior to the first dose of the investigational drug may be enrolled).\n    4. History of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 6 months prior to the first dose.\n14. Hypertension (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥90 mmHg) that has not been effectively controlled after treatment with standardized antihypertensive medication.\n15. Patients with active hepatitis B or C. In case of positive hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb) during the screening period, further hepatitis B virus (HBV) DNA titer testing must be performed (HBV DNA≤200 IU\u002FmL is required). Patients who are positive for hepatitis C virus (HCV) must receive further HCV RNA testing (no higher than the upper limit of the detection value at their study site); patients may be enrolled in the study only after active hepatitis B or C requiring treatment has been excluded.\n16. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive);\n17. Known history of Grade 3 to 4 hypersensitivity reactions to any biological product, history of life threatening hypersensitivity reactions, or known hypersensitivity to components of SG1906 drug product (Grade ≥3 hypersensitivity reactions).\n18. Have received any of the following treatments or procedures:\n\n    1. Prior treatment with any antitumor therapy targeting CLDN18.2 or CD47\n    2. Patients who have undergone open surgery ≤3 months prior to the first dose (except for surgeries for the purpose of biopsy).\n    3. Prior allogeneic organ grafting.\n    4. Systemic anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy and immunotherapy) within 28 days or 5 drug half-lives (whichever is shorter) prior to the first dose of the investigational drug, and all AEs have not returned to grade ≤1 (CTCAE 5.0), except for alopecia.\n    5. Radiotherapy ≤14 days prior to the first dose of the investigational drug; palliative radiotherapy is allowed if it is completed within 2 weeks prior to the enrollment in the study and radiotherapy-related toxicity has recovered to grade ≤1 (CTCAE 5.0), except for alopecia\n    6. Any live vaccine within 4 weeks prior to the first dose of the investigational drug\n    7. Have received treatment with various growth factors, blood transfusions or other blood products for anemia or decreased platelet count within 14 days prior to the first dose of the investigational drug.\n19. Have received systemic corticosteroids (at a dose equivalent to \\>10 mg\u002Fday prednisone) or other immunosuppressive drugs within 14 days prior to the first dose. The following are permitted:\n\n    1. Topical or inhaled glucocorticoids in physiologic replacement doses are allowed\n    2. The use of short-course (≤7 days) corticosteroids at physiologic replacement doses for the prevention or treatment of non-autoimmune diseases is allowed.\n20. Any other condition that, in the opinion of the Investigator, may lead to inappropriate participation in this study.",{"count":127,"type":21},60,[53],"This is a Phase Ia\u002FIb Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG1906 in Patients with CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Solid Tumors.",[107],"2025-06-24",{"date":133,"type":34},"2025-06-25",{"date":135,"type":34},"2023-05-30",{"date":137,"type":21},"2027-08-30",{"name":139,"class":41},"Hangzhou Sumgen Biotech Co., Ltd.",9,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":148,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100514438","phase-1-a-study-of-txn10128-in-subjects-with-solid-tumors-100514438","NCT05978492","A Study of TXN10128 in Subjects With Solid Tumors","A Multicenter, Open-label, Phase 1 Dose Escalation and Expansion Study of TXN10128, an Inhibitor of ENPP1 as Monotherapy and Combination Therapy With Irinotecan or Paclitaxel in Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Male or female subjects ≥19 years of age at the time of informed consent.\n* Histologically and\u002For cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, or standard therapy does not exist or is not considered appropriate.\n* ECOG performance status of 0 or 1.\n* Life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n* Has leptomeningeal disease.\n* Experienced a Grade ≥3 immune-related adverse events (irAE) with prior immunotherapy with the exception of non-clinically significant laboratory abnormalities.\n* Prior organ transplantation.\n* Known positive human immunodeficiency virus (HIV) infection.","19 Years",{"count":150,"type":21},96,[53],"This is a phase I clinical trial to primarily evaluate the safety, tolerability, and addtionally assess pharmacokinetics, pharmacodynamics, and antitumor activity of investigational product, TXN10128. The target subjects will be consisted of patients with locally advanced (unresectable) or metastatic soild tumors.\n\nThis study includes a dose-escalation part and a dose-expansion part, and a TXN10128 monotherapy part and a TXN10128 + Irinotecan or Paclitaxel combination therapy part.",[27],[155,156,157,158,159,160,161],"ENPP1","ENPP1 inhibitor","TXN10128","TxinnoBio","Txinno Bioscience","Innate immune","STING pathway","2025-04-21",{"date":164,"type":34},"2025-04-24",{"date":166,"type":34},"2023-07-27",{"date":168,"type":21},"2026-06-30",{"name":170,"class":41},"Txinno Bioscience Inc.",6,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":171},"100488138","phase-1-a-first-in-human-study-of-ibi354-in-subjects-with-locally-advanced-unresectable-or-metastatic-solid-tumors-100488138","NCT05636215","A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors","A Phase 1\u002F2, Multicenter, Open-label Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Male or female subjects, ≥ 18 years\n2. Phase 1a : Has a pathologically documented advanced\u002Funresectable or metastatic solid tumor with HER2 alterations (IHC 1+, IHC 2+, IHC 3+ and\u002For ISH+ and\u002For NGS confirmed mutant or amplification).\n\n   Phase 1b\u002F2: Selected solid tumors enrolled Subjects with advanced GC\u002FBC\u002FBTC\u002FCRC\u002FGyn with her2 expression (IHC 1+, IHC 2+, IHC 3+ and\u002For ISH+).\n3. Adequate bone marrow and organ function\n4. Subjects, both male and female, who are either not of childbearing potential or who agree to use at least one highly effective method of contraception during the study (begin from screening or within 2 weeks prior to the first dose, whichever comes first, and continue until 6 months after the last dose of study drug); Subjects, both male and female, who are either not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug\n5. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;\n6. Have LVEF ≥ 50% by echocardiography (ECHO) within 28 days before study drug administration.\n\nExclusion Criteria:\n\n1. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter;\n2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;\n3. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives (whichever is longer) before first administration of the study drug.\n4. Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigators' opinion) or baseline prior to first administration of the study drug;\n5. Known symptomatic central nervous system (CNS) metastases.\n6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging at screening period;\n7. Uncontrolled diseases including:\n\n   * Uncontrolled infection requiring systematic antibiotics, antivirals or antifungals within 2 weeks prior to first administration of the study drug;\n   * Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1\u002F2 Ab positive);\n   * 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 HCV Ab positive with HCV RNA\\>103 copies\u002FmL;\n   * Active infection with COVID-19;\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, symptomatic or uncontrolled arrhythmias, QTc interval \\> 480 ms or personal or family history of congenital long\u002Fshort QT syndrome;\n   * SBP ≥ 160mmHg or DBP ≥ 100mmHg;\n8. History of any arterial thromboembolic event within 6 months prior to the first administration of study drug, including myocardial infarction, unstable angina pectoris, cerebrovascular stroke or transient ischemic attack, etc.;\n9. Risk of intestinal obstruction or perforation (including but not limited to: acute diverticulitis, abdominal abscess, etc.) or a history of inflammatory bowel disease, Crohn's disease, ulcerative colitis, or chronic diarrhea;\n10. Do not have adequate treatment washout period before study drug administration, defined as:\n\n    * Major surgery; ≥ 4 weeks.\n    * Radiation therapy；≥ 4 weeks (if palliative stereotactic radiation therapy, ≥ 2 weeks).\n    * Autologous transplantation；≥ 3 months.\n    * Hormonal therapy；≥ 2 weeks.\n    * Chemotherapy (including antibody drug therapy or other antitumor therapy)； ≥ 3 weeks.\n    * Immunotherapy； ≥ 4 weeks.\n    * Cytochrome P450 (CYP) 3A4 strong inhibitor；≥ 3 elimination half-lives of the inhibitor.",{"count":180,"type":21},368,[53,24],"This is a Phase 1\u002F2, open-label, multicenter study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI354 (study drug), and to explore and confirm the efficacy, safety and tolerability of IBI354 in subjects with locally advanced unresectable or metastatic solid tumors.",[107],"2025-03-19",{"date":186,"type":34},"2025-03-20",{"date":188,"type":34},"2023-04-04",{"date":190,"type":21},"2025-10-31",{"name":116,"class":41}]