New hope for bile duct cancer: experimental drug combo enters Mid-Stage trial
NCT ID NCT07151872
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This Phase II trial tests an experimental drug called QLS31905 combined with chemotherapy, with or without another drug (QL2107), in 120 people with advanced biliary tract cancer that has a specific protein (CLDN18.2). The goal is to see if the combination shrinks tumors. Participants must not have had prior treatment for advanced disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QLS31905 (an experimental drug) combined with chemotherapy (gemcitabine, cisplatin, oxaliplatin, capecitabine) and possibly QL2107
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced biliary tract cancer that has a specific marker (CLDN18.2).
- What could go wrong
- This is an early Phase II trial with only 120 people, so results may not apply to everyone. The drug combination may cause side effects or not work better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 to 75 years
- 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: * Subjects with unresectable locally advanced or metastatic Biliary Tract Cancer confirmed by histopathological or cytological examination; * Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.1. Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD; * No prior systemic anti-tumor treatment for locally advanced or metastatic Biliary Tract Cancer. Exclusion Criteria: * Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Gemcitabine Hydrochloride for Injection, Cisplatin for Injection, Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations; * Subjects had other second primary malignancies within 5 years prior to the first dose; * Subjects with clinically significant hemorrhage within 3 months before the first dose;
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Get notified about this study
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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.