[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"becotatug-vedotin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:becotatug-vedotin":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100646274","phase-2-becotatugvedotin-plus-pucotenlimab-in-egfr-positive-advanced-gastricgej-adenocarcinoma-100646274",false,"NCT07692334","Becotatugvedotin Plus Pucotenlimab in EGFR-Positive Advanced Gastric\u002FGEJ Adenocarcinoma","A Single-Arm, Open-Label, Phase II Study of Becotatugvedotin Combined With Pucotenlimab in Patients With EGFR-Positive Advanced\u002FMetastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed Standard First-Line Therapy","Inclusion Criteria:\n\n1. Voluntarily provide written informed consent and be willing and able to comply with all study procedures and follow-up requirements.\n2. Age 18 to 75 years, regardless of sex.\n3. Histologically or cytologically confirmed unresectable locally advanced, recurrent, or metastatic gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma.\n4. EGFR-positive tumor confirmed by immunohistochemistry (IHC) performed on archival or newly obtained tumor tissue. EGFR positivity is defined as IHC 1+, 2+, 3+, or 4+, corresponding to membrane staining in ≥1% of tumor cells.\n5. Disease progression, recurrence, or intolerance following one prior line of systemic therapy for advanced or metastatic disease, including a fluoropyrimidine- and platinum-based regimen with or without a PD-1 inhibitor, and considered eligible for second-line treatment. Patients who relapse within 6 months after completion of neoadjuvant or adjuvant chemotherapy are considered to have failed first-line therapy.\n6. At least one measurable lesion according to RECIST version 1.1.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n8. Estimated life expectancy of at least 12 weeks.\n9. Adequate organ function within 14 days prior to enrollment:\n\n   Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL; Platelet count ≥100 × 10⁹\u002FL; Hemoglobin ≥90 g\u002FL; Total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN (≤5 × ULN in patients with liver metastases); Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCl) ≥50 mL\u002Fmin; INR ≤1.5 × ULN, or therapeutic anticoagulation with stable coagulation parameters considered acceptable by the investigator.\n10. Women of childbearing potential must have a negative pregnancy test before enrollment. Male and female participants of reproductive potential must agree to use effective contraception during study treatment and for at least 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Prior treatment with any EGFR-targeting antibody-drug conjugate (ADC), including becotatug vedotin (MRG003) or similar EGFR-targeting ADCs. Previous treatment with anti-EGFR monoclonal antibodies (e.g., cetuximab) is permitted.\n2. Receipt of chemotherapy, targeted therapy, immunotherapy, or other anti-cancer therapy within 4 weeks before study treatment initiation, or unresolved treatment-related toxicities \\> Grade 1 (except alopecia). Radiotherapy within 4 weeks (or palliative radiotherapy within 2 weeks) before enrollment.\n3. HER2-positive disease (IHC 3+ or IHC 2+ with ISH\u002FFISH amplification).\n4. Untreated or uncontrolled central nervous system (CNS) metastases or leptomeningeal disease. Patients with previously treated brain metastases may be enrolled if clinically stable for at least 4 weeks and receiving no more than prednisone 10 mg\u002Fday (or equivalent).\n5. Current or previous interstitial lung disease (ILD), immune-related pneumonitis, or active pneumonitis requiring systemic corticosteroid treatment.\n6. Active autoimmune disease requiring systemic immunosuppressive therapy, or history of organ transplantation requiring immunosuppressive treatment.\n7. Uncontrolled active infection, including severe bacterial infection requiring intravenous antibiotics, active tuberculosis, hepatitis B virus (HBV) DNA \\>2,000 IU\u002FmL or without appropriate antiviral therapy, untreated hepatitis C virus (HCV) infection with detectable HCV RNA, or uncontrolled human immunodeficiency virus (HIV) infection.\n8. Significant cardiovascular or other serious uncontrolled systemic diseases, including myocardial infarction, unstable angina, New York Heart Association (NYHA) class III-IV heart failure, severe arrhythmia, QTc \\>470 ms within 6 months before enrollment, or any other condition judged by the investigator to interfere with study participation.\n9. Baseline Grade ≥2 peripheral neuropathy or clinically significant sensory neuropathy.\n10. Active gastrointestinal bleeding, gastrointestinal perforation, bowel obstruction, or gastrointestinal conditions requiring urgent surgical or interventional treatment.\n11. History of another active malignancy within the previous 5 years, except adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies with negligible risk of recurrence.\n12. Pregnant or breastfeeding women, or individuals planning pregnancy during the study period.\n13. Known severe hypersensitivity to becotatug vedotin, pucotenlimab, or any of their excipients.\n14. Any medical, psychiatric, social, or compliance-related condition that, in the opinion of the investigator, would compromise participant safety, interfere with study participation, or affect interpretation of study results.\n15. Participation in another interventional clinical trial within 4 weeks before enrollment or concurrent participation in another clinical trial involving investigational agents.","ALL","18 Years","75 Years",{"count":20,"type":21},28,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Advanced gastric cancer (AGC) and gastroesophageal junction (GEJ) adenocarcinoma remain associated with poor prognosis after failure of first-line systemic therapy. Although immune checkpoint inhibitor-based chemoimmunotherapy has become the standard first-line treatment for HER2-negative advanced disease, most patients eventually experience disease progression. Current second-line treatment options provide limited clinical benefit, highlighting the need for novel therapeutic strategies.\n\nEpidermal growth factor receptor (EGFR) is overexpressed in approximately 20-30% of gastric cancers and is associated with aggressive tumor biology and poor prognosis. Previous studies evaluating anti-EGFR monoclonal antibodies or tyrosine kinase inhibitors in unselected gastric cancer populations failed to demonstrate survival benefit, largely because of the lack of biomarker-based patient selection and the limited efficacy of conventional EGFR-targeted agents. Becotatug vedotin (MRG003), an EGFR-directed antibody-drug conjugate (ADC) carrying monomethyl auristatin E (MMAE), exerts potent cytotoxic activity through EGFR-mediated internalization and intracellular payload release. In addition, MMAE-containing ADCs may induce immunogenic cell death and remodel the tumor immune microenvironment, providing a strong biological rationale for combination with programmed cell death protein-1 (PD-1) blockade. Pucotenlimab is a humanized anti-PD-1 monoclonal antibody with demonstrated antitumor activity and favorable safety in multiple solid tumors.\n\nThis is a prospective, single-center, open-label, single-arm phase II investigator-initiated trial designed to evaluate the efficacy and safety of becotatug vedotin in combination with pucotenlimab as second-line treatment in patients with EGFR-positive unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma who have progressed after standard first-line therapy. Approximately 28 patients will be enrolled. Participants will receive becotatug vedotin (2.0 mg\u002Fkg, intravenous infusion, every 3 weeks) plus pucotenlimab (200 mg, intravenous infusion, every 3 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.\n\nThe primary endpoint is objective response rate (ORR) assessed according to RECIST version 1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), time to response (TTR), and safety. Exploratory analyses will evaluate the association between treatment outcomes and biomarkers including EGFR expression, PD-L1 expression, tumor mutational burden, microsatellite instability\u002Fmismatch repair status, and immune-related biomarkers, aiming to identify patients most likely to benefit from this combination therapy.",[27,28,29,30],"Gastric Cancer","Gastroesophageal Junction (GEJ) Adenocarcinoma","Becotatug Vedotin","Pucotenlimab","NOT_YET_RECRUITING","2026-07-03",{"date":34,"type":35},"2026-07-09","ACTUAL",{"date":37,"type":21},"2026-07-20",{"date":39,"type":21},"2027-12-31",{"name":41,"class":42},"West China Second University Hospital","OTHER",{"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":53,"conditions":54,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100633845","phase-2-prospective-open-label-multi-cohort-study-of-becotatug-vedotin-with-tislelizumab-and-chemotherapy-in-esophageal-squamous-cell-carcinoma---phase-2-100633845","NCT07531979","Prospective, Open-label, Multi-cohort Study of Becotatug Vedotin With Tislelizumab and Chemotherapy in Esophageal Squamous Cell Carcinoma - Phase 2","A Prospective, Open-label, Multicohort, Phase II Clinical Study of Becotatug Vedotin in Combination With Tislelizumab and Chemotherapy for Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Male or non-pregnant, non-lactating female.\n3. ECOG performance status of 0 or 1, with no deterioration within 7 days.\n4. Histologically confirmed locally advanced or metastatic esophageal squamous cell carcinoma.\n5. No prior systemic therapy for ESCC. Patients who have received neoadjuvant or adjuvant therapy must have experienced disease progression or recurrence more than 6 months after completion of that treatment.\n6. Patients with metastatic disease must have at least one measurable lesion per RECIST 1.1 criteria; patients with disease after neoadjuvant therapy must have an evaluable lesion.\n7. Adequate organ and bone marrow function, as demonstrated by the following laboratory values:\n\n   1. Hemoglobin (HGB) ≥ 90 g\u002FL.\n   2. Absolute neutrophil count (NEUT) ≥ 1.5 × 10⁹\u002FL.\n   3. Platelet count (PLT) ≥ 80 × 10⁹\u002FL.\n   4. Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN).\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN.\n   6. Creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n   7. Urine protein \\\u003C (++) or 24-hour urinary protein \\\u003C 1.0 g.\n8. Normal coagulation function and no active bleeding:\n\n   1. International Normalized Ratio (INR) ≤ 1.5.\n   2. Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.\n9. For women of childbearing potential: negative pregnancy test (serum or urine) within 14 days prior to enrollment, and agreement to use adequate contraception during the study period and for 8 weeks after the last dose of study drug. For men: surgically sterile or agreement to use adequate contraception during the study period and for 8 weeks after the last dose of study drug.\n10. Expected survival ≥ 6 months.\n11. Patient voluntarily participates in the study and signs the informed consent form (ICF).\n12. Patient is expected to be compliant and able to undergo follow-up for efficacy and adverse events as required by the protocol.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria at screening will be excluded from the study:\n\n1. Prior treatment with any anti-EGFR monoclonal antibody, or with anti-PD-1\u002FPD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, CTLA-4 antibody, or any other drug\u002Fantibody targeting T-cell co-stimulation or checkpoint pathways.\n2. Administration of a live vaccine within 4 weeks prior to enrollment or anticipated during the study period.\n3. Active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment.\n4. Prior allogeneic bone marrow transplantation or solid organ transplant.\n5. Uncontrolled hypertension at enrollment, defined as: systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg.\n6. Any disease or condition affecting drug absorption at enrollment.\n7. Clinically significant cardiovascular disease, including but not limited to: acute myocardial infarction within 6 months prior to enrollment; severe\u002Funstable angina or coronary artery bypass grafting; congestive heart failure \\> New York Heart Association (NYHA) Class 2; ventricular arrhythmias requiring medication; left ventricular ejection fraction (LVEF) \\\u003C 50%.\n8. Active or uncontrolled severe infection (≥ CTCAE v5.0 Grade 2 infection).\n9. Known HIV infection. Known clinically significant liver disease, including viral hepatitis \\[known hepatitis B virus (HBV) carriers must be excluded if they have active HBV infection, i.e., HBV DNA positive (\\>1×10⁴ copies\u002FmL or \\>2000 IU\u002FmL); known hepatitis C virus (HCV) infection with HCV RNA positive (\\>1×10³ copies\u002FmL)\\].\n10. Any other disease, clinically significant metabolic abnormality, physical examination finding, or laboratory abnormality that, in the investigator's judgment, reasonably suggests the presence of a disease or condition that contraindicates the use of the investigational drug (e.g., a condition associated with seizures requiring treatment), would affect the interpretation of study results, or would place the patient at high risk.\n11. Patients deemed by the investigator to be unsuitable for participation in this study.",{"count":51,"type":21},93,[24],"Esophageal squamous cell carcinoma (ESCC) is a common malignant tumor worldwide, with particularly high incidence in East Asian regions such as China, and is associated with poor patient prognosis. In recent years, immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1 antibodies) combined with chemotherapy have become the standard first-line treatment for advanced ESCC. Multiple randomized controlled trials have confirmed that this combination significantly improves patient survival compared to chemotherapy alone. However, a subset of patients still exhibit poor response or develop resistance to the immunotherapy-chemotherapy regimen, necessitating the exploration of novel combination strategies to further enhance efficacy.\n\nThe epidermal growth factor receptor (EGFR) is frequently overexpressed in ESCC and is associated with tumor proliferation, metastasis, and poor prognosis, making it an important therapeutic target. Antibody-drug conjugates (ADCs) targeting EGFR achieve precise tumor killing by conjugating an anti-EGFR antibody to a potent cytotoxic payload. Preclinical studies have demonstrated significant antitumor activity of EGFR ADCs in ESCC models. Mechanistically, anti-EGFR therapy and immune checkpoint inhibitor therapy may exert synergistic effects through several avenues: enhancing tumor antigen presentation, remodeling the tumor microenvironment, and modulating PD-L1 expression. Therefore, this triple combination strategy holds promise for overcoming the limitations of monotherapies and providing a new treatment option for patients with ESCC.",[55,56,57,29,58,59],"ESCC","Tislelizumab","Chemotherapy","EGFR ADC","PD-1 Inhibitor","2026-04-13",{"date":62,"type":35},"2026-04-15",{"date":64,"type":21},"2026-04-01",{"date":66,"type":21},"2029-12-31",{"name":68,"class":42},"Tianjin Medical University Cancer Institute and Hospital",1]