A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression)
NCT05135715 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-02-20
Summary
This is a Phase IIa, single-arm, multicentre, open-label clinical trial aims to evaluate the effectiveness and safety of RC48-ADC in the treatment of HER2 Variant (Mutation, Amplification, Overexpression) advanced melanoma.
Conditions
- Melanoma, Stage II
- HER2-positive
- Advanced Melanoma
Interventions
- DRUG
-
RC48-ADC
2.0 mg/kg IV every 2 weeks
Sponsors & Collaborators
-
RemeGen Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jun Guo, Ph.D · Peking University Cancer Hospital & Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-19
- Primary Completion
- 2024-12-30
- Completion
- 2025-12-30
Countries
- China
Study Locations
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