Clinical Trial

A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors

Recruiting Phase 1
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Summary
In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1. In phase Ib study, the safety and tolerability of BL-M07D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M07D1 in patients
Protocol Amendment History 1 change
notable Enrollment increased: 26 -> 348 participants 2026-08-04
Trial Details
NCT Number NCT05461768
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: SystImmune Inc., Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Breast Cancer, Locally Advanced or Metastatic Solid Tumor
Enrollment 348 participants
Start Date 2022-08-09
Primary Completion 2026-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-03