Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations

Sponsor
Sir Run Run Shaw Hospital
Study ID
NCT07598318
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Becotatug Vedotin — DRUG
    Becotatug Vedotin：2mg/kg，IV，Q3W，D1
  • Pucotenlimab — DRUG
    Pucotenlimab：200mg，IV，Q3W，D1
  • Gemcitabine — DRUG
    Gemcitabine：1000mg/m²，IV，D1、D8，Q3W. Each course lasts for 8 weeks. The maximum treatment duration is 8 courses.
  • Cisplatin — DRUG
    Cisplatin：25mg/m²，IV，D1、D8，Q3W. Each course lasts for 8 weeks. The maximum treatment duration is 8 courses.

Study Details

This study tests whether adding becotatug vedotin (EGFR-ADC) to standard chemotherapy plus immunotherapy improves outcomes compared to chemotherapy plus immunotherapy alone as first-line treatment for patients with advanced or metastatic biliary tract cancer whose tumors carry EGFR mutations. Participants will be randomly assigned to receive either the experimental combination (becotatug vedotin + pucotenlimab + gemcitabine + cisplatin) or the control combination (pucotenlimab + gemcitabine + cisplatin). The main goal is to see if the experimental group has a higher objective response rate (tumor shrinkage rate). This is a randomized, controlled, open-label, multicenter study led by Sir Run Run Shaw Hospital, Zhejiang University, with Dr. Chen Mingyu as the principal investigator.

Key Dates

First listed
May 20, 2026
Start date
May 20, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Becotatug Vedotin Intervention Arm
    Becotatug Vedotin + Pucotenlimab + Gemcitabine + Cisplatin
  • Active Comparator: No Becotatug Vedotin Control Arm
    Pucotenlimab + Gemcitabine + Cisplatin

Primary Outcome Measure

ORR [ Time Frame: After two treatment cycles（each cycle is 28 days） ]

Central Contacts

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