Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006
NCT05414136 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2024-12-24
Summary
Primary objectives: To evaluate the safety and tolerability of BAT1006 in patients with advanced her2-positive solid tumors. To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of BAT1006 after single and multiple dosing; 2) To study the immunogenicity of BAT1006; 3) Preliminary evaluation of anti-tumor efficacy of BAT1006.
Conditions
- Advanced Solid Tumor
Interventions
- DRUG
-
BAT1006
Intravenous fluids
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Shusen Wang · Sun Yat-sen University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-10
- Primary Completion
- 2024-06-17
- Completion
- 2024-06-17
Countries
- China
Study Locations
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