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VISTA-ESCCNCT07892833

Becotatug Vedotin in Combination With Immunotherapy and Multimodality Radiotherapy for Esophageal Squamous Cell Carcinoma in the Second-line or Later Setting

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Objective Response Rate
Timeframe: up to 2years

Secondary (5)

Disease Control Rate
Progression-Free Survival
Overall survival
Duration of relief
Treatment Emergent Adverse Events (Safety and Tolerability)

Arms and interventions

ExperimentalExperimental

Becotatug vedotin (MRG003): 2.0 mg/kg, D1,Q3W, starting at least 30 minutes after completion of the ICI infusion. Immune checkpoint inhibitor: Investigator's choice, including but not limited to camrelizumab, tislelizumab, and pembrolizumab; Q3W, IV, Day 1, with infusion duration per the respective prescribing information. Multimodal radiotherapy: Initiated within the first 2 cycles of systemic therapy (no later than the end of Cycle 2), targeting the primary lesion and/or metastatic lesions. An individualized radiotherapy plan is delivered, using conventionally fractionated radiotherapy or SBRT, at approximately 50-60 Gy in 25-30 fractions (or a biologically equivalent dose/fractionation schedule). Investigators may appropriately adjust the timing, dose, and fractionation. Whether the ICI is withheld during radiotherapy is left to the investigator's discretion based on the patient's clinical condition.

Drugs: Becotatug vedotin (MRG003)

Sites

1 site in 1 country

  • The First Affiliated Hospital of Bengbu Medical UniversityBengbu, Anhui, China