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Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II

NCT07649980 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-16

No results posted yet for this study

Summary

Biliary tract carcinoma (BTC), including cholangiocarcinoma and gallbladder cancer, is a highly aggressive digestive system malignancy with limited treatment options after failure of first-line standard chemotherapy.

This open-label, single-arm, Phase II exploratory study aims to evaluate the efficacy and safety of Becotatug Vedotin combined with Pucotenlimab in patients with EGFR-positive advanced BTC who have failed first-line therapy. Participants will receive the combination regimen until the occurrence of disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator's decision to discontinue treatment, or study termination, whichever occurs first.The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.

Conditions

  • Biliary Tract Cancer (BTC)
  • EGFR-positive Advanced Biliary Tract Carcinoma

Interventions

DRUG

Becotatug Vedotin

2.0mg/kg ，IV，D1，Q3W；The infusion duration is 60 minutes ± 15 minutes, with the first infusion lasting no less than 60 minutes.

DRUG

Pucotenlimab

200mg，IV，D1，Q3W；The infusion duration is 60 minutes ± 15 minutes, with the first infusion lasting no less than 60 minutes.

Sponsors & Collaborators

  • HuiKai Li

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2029-07-01
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07649980 on ClinicalTrials.gov