A Study of FDA022-BB05 in Advanced/Metastatic Solid Tumors
NCT06413615 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2024-09-26
Summary
This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing/expressing solid tumors which are not eligible for curative therapy.
Conditions
- Advanced Solid Tumor
Interventions
- DRUG
-
FDA022-BB05
Monoclonal antibody-drug conjugate for injection
Sponsors & Collaborators
-
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jian Zhang, MD · Fudan University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-13
- Primary Completion
- 2025-07-31
- Completion
- 2026-06-30
Countries
- China
Study Locations
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