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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

Name: 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 — clinical trial record (NCT07730489)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusNot Yet Recruiting

PhasePhase 3

SponsorSichuan Baili Pharmaceutical Co., Ltd.

Started2026-08

View on ClinicalTrials.gov ↗

Amendment history

2026-08-25

Study Status, Contacts/Locations v1

Study sitescontacts updated at 2 of 2 sites

2026-07-23

Original filing

Sichuan Baili Pharmaceutical Co., Ltd.

135 trials monitored

See 14 trials at risk

Colorectal Cancer

2,904 trials monitored

See 127 trials at risk

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.

Trial Details

NCT Number	NCT07730489
Lead Sponsor	Sichuan Baili Pharmaceutical Co., Ltd. Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions	Colorectal Cancer
Enrollment	130 participants
Start Date	2026-08
Primary Completion	2027-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-27