RemeGen Co., Ltd.
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.
Melanoma, Stage II
HER2-positive
Advanced Melanoma
RC48-ADC
Phase 2
This study is a phase IIa multicentre,single-arm, open-label, clinical study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of HER2- positive advanced melanoma. HER2 mutation is defined as the presence of HER2 gene mutations in primary or metastatic tumour tissue as detected by immunohistochemistry (IHC). HER2 gene mutation.}}
Study Type : | Interventional |
Estimated Enrollment : | 50 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Single-arm, Multicentre, Open Phase Ⅱa Clinical Study of RC48-ADC in the Treatment of HER2 Variant (Mutation, Amplification, Overexpression) Advanced Melanoma |
Actual Study Start Date : | April 19, 2022 |
Estimated Primary Completion Date : | December 30, 2024 |
Estimated Study Completion Date : | December 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: RC48-ADC Participants will receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
Drug: RC48-ADC |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Fujian cancer hospital
F U axis, Fujian, China,
Recruiting
The First Hospital of Jilin University
Changchun, Jilin, China,
Recruiting
ZHejiang cancer hospital
Hangzhou, Zhejiang, China,
Recruiting
Beijing Cancer Hospital
Beijing, China,