[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"I-Mab Biopharma US Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100626181","phase-2-givastomig-combined-with-nivolumab-and-chemotherapy-in-adults-with-cldn182-positive-metastatic-gastric-cancer-giva-2-100626181",false,"NCT07432295","Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)","A Randomized, Multicenter, Open-Label, Phase 2 Study of Givastomig (TJ033721) in Combination With Nivolumab and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated CLDN18.2 Positive and PD-1L Positive Locally Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Histologically confirmed unresectable, locally advanced, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).\n* Treatment-naïve for advanced\u002Fmetastatic disease (prior adjuvant\u002Fneoadjuvant therapy allowed if ≥6 months since last dose).\n* CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells).\n* PD-L1 positive (CPS ≥1).\n* At least 1 measurable lesion per RECIST v1.1.\n* ECOG performance status 0 or 1.\n* Adequate organ function, including:\n\n  * Hematologic: WBC ≥2,000\u002FμL; ANC ≥1,500\u002FμL; platelets ≥100,000\u002FμL; hemoglobin ≥9 g\u002FdL\n  * Hepatic: AST\u002FALT ≤3×ULN (≤5×ULN if liver metastases); bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's)\n  * Renal: Creatinine ≤1.5×ULN or eGFR ≥50 mL\u002Fmin\u002F1.73 m²\n* Life expectancy ≥90 days.\n* Women of childbearing potential (WOCBP) and men must use effective contraception during the study and for a defined period after treatment.\n* Willing and able to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* HER2-positive tumors.\n* Second malignancy within 3 years, except certain skin or cervical cancers.\n* Active or unstable gastrointestinal ulcer or bleeding within 6 weeks.\n* Active autoimmune disease requiring systemic therapy within past 2 years or ongoing immunosuppressive therapy.\n* Active pneumonitis or history requiring steroids\u002Fimmunosuppressive therapy within 3 years.\n* Participation in another therapeutic clinical trial.\n* Major surgery or significant injury within 4 weeks prior to first dose, or planned major surgery within 6 months.\n* Radiotherapy within protocol-specified timeframes without adequate recovery.\n* Active CNS metastases or carcinomatous meningitis (previously treated brain metastases allowed if stable).\n* Significant cardiovascular disease (NYHA Class 3-4 CHF, recent MI, unstable angina, TIA\u002Fstroke, or major cardiac procedures within 6 months).\n* Active or uncontrolled HIV, hepatitis B, or hepatitis C infection, or immunodeficiency (controlled infection allowed).\n* Receipt of live vaccine within 30 days or other vaccines within 7 days of first dose.\n* Active infection requiring parenteral therapy.\n* Known hypersensitivity to study drug components (e.g., DPD deficiency).\n* Any other condition or laboratory abnormality that, in the investigator's judgment, increases risk or interferes with study participation.","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and\u002For esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are:\n\n* Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer?\n* What toxicities do participants experience when taking givastomig?\n\nParticipants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part.\n\nUp to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks.\n\nParticipants will:\n\n* Visit the study treatment center for infusions and\u002For check-ups and tests every 1-3 weeks\n* Report any changes in their symptoms to their study doctors\n* Have scans to check for any changes in their cancer every 8-12 weeks",[26,27,28,29,30,31],"Solid Tumor","Advanced Cancer","Metastatic Cancer","Gastric Cancer","Gastroesophageal Junction Carcinoma","Esophageal Adenocarcinoma","RECRUITING","2026-05-11",{"date":35,"type":36},"2026-05-14","ACTUAL",{"date":38,"type":36},"2026-02-11",{"date":40,"type":20},"2030-08",{"name":42,"class":43},"I-Mab Biopharma US Limited","INDUSTRY",6,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100431646","phase-1-study-of-tj033721-givastomig-in-subjects-with-advanced-or-metastatic-solid-tumors-100431646","NCT04900818","Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors","A Phase 1 Study of TJ033721 in Subjects With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nPart 1 - Monotherapy Subjects with advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options.\n\nPart 2 - Combination Therapy Subjects with treatment naïve locally advanced, unresectable or metastatic gastric, GEJ, esophageal adenocarcinoma;\n\nPart 3: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed pancreatic adenocarcinoma;\n\nPart 4: Combination Therapy Subjects with unresectable, locally advanced or metastatic histologically confirmed biliary tract cancer.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with adequate organ function\n* Have known PD-L1 status with prior testing by immunohistochemistry and a corresponding combined positive score (CPS)\n\nFor dose expansion and Part 2, Part 3, Part 4 Combination subjects:\n\n• Must have CLDN18.2-positive tumor expression\n\nExclusion Criteria\n\n* Prior exposure to CLDN18.2 -targeted therapy\n* Prior exposure to 4-1BB agonists\n* Second malignancy within the last 3 years with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ\n* Known active or chronic Hepatitis B or Hepatitis C, other hepatitides\n* Unstable\u002Factive ulcer or digestive tract bleeding within 6 weeks\n* Active autoimmune disease requiring systemic treatment within the past 2 years\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;\n* New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, severe\u002Funstable angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack (TIA), arterial embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) in the previous 6 months\n* Diagnosis of immunodeficiency such as known active HIV\n* Any active infection requiring parenteral treatment\n\nFor Part 2, 3, 4 Combination subjects:\n\n• Prior treatment with anti-PD-1 or PD-L1 agent",{"count":53,"type":20},330,[55],"PHASE1","This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.",[26,27,28,29,30,31,58,59],"PDAC - Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancer (BTC)","2026-03-03",{"date":62,"type":36},"2026-03-05",{"date":64,"type":36},"2021-06-29",{"date":66,"type":20},"2027-12",{"name":42,"class":43},21,""]