Prospective, Open-label, Multi-cohort Study of Becotatug Vedotin With Tislelizumab and Chemothera… (NCT07531979) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Prospective, Open-label, Multi-cohort Study of Becotatug Vedotin With Tislelizumab and Chemotherapy in Esophageal Squamous Cell Carcinoma - Phase 2
China93 participantsStarted 2026-04-01
Plain-language summary
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/PD-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.
The 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years.
✓. Male or non-pregnant, non-lactating female.
✓. ECOG performance status of 0 or 1, with no deterioration within 7 days.
✓. 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.
✓. 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.
✓. Adequate organ and bone marrow function, as demonstrated by the following laboratory values:
✓. Hemoglobin (HGB) ≥ 90 g/L.
Exclusion criteria
✕. Prior treatment with any anti-EGFR monoclonal antibody, or with anti-PD-1/PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, CTLA-4 antibody, or any other drug/antibody targeting T-cell co-stimulation or checkpoint pathways.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: up to 24 months
Trial details
NCT IDNCT07531979
SponsorTianjin Medical University Cancer Institute and Hospital
✕. Administration of a live vaccine within 4 weeks prior to enrollment or anticipated during the study period.
✕. Active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment.
✕. Prior allogeneic bone marrow transplantation or solid organ transplant.
✕. Uncontrolled hypertension at enrollment, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
✕. Any disease or condition affecting drug absorption at enrollment.
✕. Clinically significant cardiovascular disease, including but not limited to: acute myocardial infarction within 6 months prior to enrollment; severe/unstable 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) \< 50%.
✕. Active or uncontrolled severe infection (≥ CTCAE v5.0 Grade 2 infection).