New combo therapy targets tough bile duct cancer
NCT ID NCT07514533
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two drugs together—pucotenlimab (which helps the immune system fight cancer) and becotatugvedotin (which targets and kills cancer cells)—in people with advanced bile duct cancer that has not responded to prior treatment. The main goal is to see how many patients' tumors shrink after two treatment cycles. About 60 adults will take part. The study is not yet recruiting.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\) Age ≥ 18 years old, both male and female are acceptable. 2) Histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma), or (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma, after previous chemotherapy failure); 3) ECOG PS score 0-1. 4) Normal major organ functions, without severe blood, heart, lung, liver, kidney, bone marrow, or immune deficiency diseases. 5\) For female subjects of childbearing age, a pregnancy test (serum/urine) result must be negative within 14 days before enrollment, and they must voluntarily use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug; for male subjects, surgical sterilization or consent to use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug is required. 6\) IHC test is positive for EGFR. 7) Expected good compliance and able to follow up on efficacy and adverse reactions as per the protocol. 8\) Voluntary participation in this study and signing the informed consent form. If the subject is unable to read and sign the informed consent form due to lack of capacity, the guardian should act on behalf of the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (such as illiterate subjects), a witness should witness the informed process and sign the informed consent form. Exclusion Criteria: * 1\) Received PD1, PDL1, PDL2, CTLA4 treatment before enrollment, or directly received another stimulating or co-inhibitory T cell receptor (such as CTLA-4, OX40, CD137) treatment. 2\) Used any other study drug within 4 weeks before enrollment. 3) Has any active autoimmune disease or autoimmune disease history (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (after hormone replacement therapy can be included)); has completely resolved childhood asthma and no need for any intervention after adulthood, and can be included, but patients requiring medical intervention with bronchodilators are not included. 4\) Has congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection. 5\) Has uncontrolled clinical symptoms or diseases of the heart, such as NYHA II or above heart failure, unstable angina pectoris, heart attack within 1 year, patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention. 6\) Had severe infection within 4 weeks before the first administration (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or had unexplained fever \> 38.5℃ during screening or before the first administration. 7\) Has a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 8\) Had a live attenuated vaccine administered within 4 weeks before the first administration or is planned to be administered during the study period. 9\) Had other systemic malignant tumors within the last 5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ and ovarian cancer). 10\) Has known allergies to any study drug. 11) Pregnant or lactating women, subjects with reproductive capacity who are unwilling to take effective contraceptive measures. 12\) Vulnerable groups other than the elderly or illiterate, including those with mental illness, cognitive impairment, critically ill patients, etc. 13\) Other situations considered by the investigator as not suitable for inclusion in this study. Such as: the patient already has central nervous system metastasis. There are serious laboratory test abnormalities, accompanied by factors related to family or society, which may affect the safety of the subjects or the collection of data/samples.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Cutting scans, keeping safety: a new streamlined approach to liver cancer treatment
- A new test could reveal how radiation affects the liver
- Can blood tests reveal how liver and bile duct cancers respond to treatment?