drugset / Trial / NCT05339685
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer or Other Solid Tumors
Phase 1
Active not recruiting
82 enrolled
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. · collabSystImmune Inc. · collab
NaSequentialOpen-labelTreatment
Summary
In phase Ia study, the safety and tolerability of BL-M02D1 in patients with locally advanced or metastatic triple negative breast cancer or other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M02D1. In phase Ib study, the safety and tolerability of BL-M02D1 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-M02D1 in patients with locally advanced or metastatic triple negative breast cancer or other solid tumors will be evaluated.
Timeline
- Start
- 2022-05-20
- Primary completion
- 2025-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BL-M02D1 | Unknown | — | Intravenous |