Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
NCT06293898 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 280
Last updated 2026-03-23
Summary
The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.
Conditions
- Endometrial Cancer
- Cervical Cancer
- Ovarian Cancer
- Urothelial Carcinoma
- Biliary Tract Cancer
- Breast Cancer
- Lung Cancer
- Gastric Cancer
- Gastroesophageal-junction Cancer
- Esophageal Cancer
Interventions
- DRUG
-
BL-M07D1
Drug: BL-M07D1 The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized. BL-M17D1 will be administered on Day 1 by intravenous infusion every 3 weeks. Other Names: BL-M07D1
Sponsors & Collaborators
-
SystImmune Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Leader · SystImmune Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-09
- Primary Completion
- 2028-12-15
- Completion
- 2029-04-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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