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

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07606599
Phase
PHASE3
Status
Recruiting
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Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BL-M07D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Oxaliplatin — DRUG
    Administration by intravenous infusion for a cycle of 2 weeks.
  • Calcium levofolinate — DRUG
    Administration by intravenous infusion for a cycle of 2 weeks.
  • Fluorouracil — DRUG
    Administration by intravenous infusion for a cycle of 2 weeks.
  • Irinotecan Hydrochloride Liposome — DRUG
    Administration by intravenous infusion for a cycle of 2 weeks.
  • Irinotecan Hydrochloride — DRUG
    Administration by intravenous infusion for a cycle of 2 weeks.
  • Capecitabine Tablets — DRUG
    Oral administration for a cycle of 2 weeks.

Study Details

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.

Key Dates

First listed
May 26, 2026
Start date
Jul 7, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: BL-M07D1
    Participants receive BL-M07D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
  • Active Comparator: mFOLFOX, FOLFnal-IRI or XELIRI
    Participants receive mFOLFOX, FOLFnal-IRI or XELIRI in the first cycle (2 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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