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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ESCC
• Tislelizumab
• Chemotherapy
• Becotatug Vedotin
• EGFR ADC
• PD-1 Inhibitor

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab 200mg IV Q3W + Followed by maintenance treatment for 2 year (Tislelizumab 200 mg IV Q3W for 6 cycles and Tislelizumab 200 mg Q3W for 28 cycles)
DRUG	Becotatug Vedotin	2mg/kg or 2.3mg/kg，D1，Q3W, 6 cycles
DRUG	Cisplatin	60mg/㎡, D1, Q3W, 6 cycles
DRUG	Tislelizumab	Tislelizumab 200mg IV Q3W + Followed by adjuvant treatment for 1 year (Tislelizumab 200 mg IV Q3W for 3 cycles and Tislelizumab 200 mg Q3W for 14 cycles)
DRUG	Becotatug Vedotin	2mg/kg or 2.3mg/kg，D1，Q3W，3 cycles
DRUG	Cisplatin	60mg/㎡ , D1，Q3W, 3 cycles

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-03-31
• Completion: 2029-12-31
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: China