A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, Fluorouracil and Irinotecan

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07730489
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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.
  • Regorafenib — DRUG
    Oral administration, once daily (QD) for a cycle of 4 weeks.
  • Fruquintinib — DRUG
    Oral administration, once daily (QD) for a cycle of 4 weeks.
  • TAS-102 — DRUG
    Oral administration, twice daily for a cycle of 4 weeks.

Study Details

This trial is a registrational Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in patients with advanced colorectal cancer who have HER2 IHC3+ and have failed prior treatment with oxaliplatin, fluorouracil and irinotecan.

Key Dates

First listed
Jul 28, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
130 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: Regorafenib, Fruquintinib or TAS-102
    Participants receive Regorafenib, Fruquintinib or TAS-102 in the first cycle (4 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

BICR-assessed Progression-free Survival (PFS) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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