Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II (NCT07649980) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II
30 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
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 female.
. Histologically or cytologically confirmed advanced biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC); recurrent biliary tract cancer is also eligible.
. EGFR expression positive by immunohistochemistry (IHC) (+, ++, or +++).
. Failed at least one line of standard systemic therapy.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Life expectancy ≥ 3 months.
. At least one measurable lesion per RECIST v1.1 on CT or MRI.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a combination of two drugs — becotatug vedotin and pucotenlimab — for biliary tract cancer that is EGFR-positive. Would my tumor need to be tested for EGFR status first, and do you know if my cancer has already been tested for that?
2Since this is a Phase II trial focused on measuring how often tumors shrink (objective response rate), what does that mean for how much is already known about whether this combination is safe and effective compared to standard treatments for biliary tract cancer?
3The trial isn't recruiting yet — given how aggressive biliary tract cancer can be, is it worth waiting for this study to open, or would starting a standard treatment now make more sense for my situation?
4What are the known or expected side effects of combining an antibody-drug conjugate like becotatug vedotin with an immunotherapy drug like pucotenlimab, and how might those risks compare to what I'd face with standard chemotherapy?
5If this trial opens and I'm potentially eligible, are there other active trials or approved treatments for advanced biliary tract cancer that my care team thinks I should consider alongside or before this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From start of treatment until disease progression, assessed up to 36 months.
. Diagnosis of another primary malignancy within 5 years prior to enrollment, except for adequately treated carcinoma in situ or basal cell carcinoma of the skin.
. EGFR expression negative by IHC.
. Known central nervous system (CNS) metastases or carcinomatous meningitis, unless clinically stable for ≥ 4 weeks after radiotherapy or surgery and asymptomatic.
. Psychiatric or neurological disorders that compromise the ability to comply with study procedures.
. Prior treatment with MMAE-containing antibody-drug conjugate (ADC) therapy.
. Planned or previous organ or bone marrow transplantation.
. Active or history of autoimmune disease requiring systemic immunosuppressive therapy.
. Receipt of live vaccine within 30 days prior to first dose. Inactivated seasonal influenza vaccines are allowed.