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A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer

Name: A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer — clinical trial record (NCT07678957)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 2

SponsorSichuan Baili Pharmaceutical Co., Ltd.

Started2026-08-31

View on ClinicalTrials.gov ↗

Amendment history

2026-09-11

Study Status, Contacts/Locations v1

Recruitment opened

Start dateestimated 2026-07→confirmed 2026-08-31

Study sitesdetails revised at 1 of 1 site

2026-06-25

Original filing

Sichuan Baili Pharmaceutical Co., Ltd.

135 trials monitored

See 14 trials at risk

Breast Cancer

5,180 trials monitored

See 256 trials at risk

This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing breast cancer.

Trial Details

NCT Number	NCT07678957
Lead Sponsor	Sichuan Baili Pharmaceutical Co., Ltd. Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions	Breast Cancer
Enrollment	120 participants
Start Date	2026-08-31
Primary Completion	2028-12 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-09-14