RecruitingPhase 3NCT07606599

A Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure

A Phase III Randomized Controlled Clinical Study of BL-M07D1 Versus Physician's Choice of Chemotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Biliary Tract Cancer After Platinum-containing Chemotherapy Failure


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

398 participants

Start Date

Jul 7, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing locally advanced or metastatic biliary tract cancer after platinum-containing chemotherapy failure.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BL-M07D1, a drug called Calcium levofolinate, and others for people with biliary tract cancer. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-M07D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGOxaliplatin

Administration by intravenous infusion for a cycle of 2 weeks.

DRUGCalcium levofolinate

Administration by intravenous infusion for a cycle of 2 weeks.

DRUGFluorouracil

Administration by intravenous infusion for a cycle of 2 weeks.

DRUGIrinotecan Hydrochloride Liposome

Administration by intravenous infusion for a cycle of 2 weeks.

DRUGIrinotecan Hydrochloride

Administration by intravenous infusion for a cycle of 2 weeks.

DRUGCapecitabine Tablets

Oral administration for a cycle of 2 weeks.


Locations(2)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07606599


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