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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
2.0 mg/kg IV every 2 weeks
Fujian cancer hospital
Fuzhou, Fujian, China
RECRUITINGThe First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGZhejiang cancer hospital
Hangzhou, Zhejiang, China
RECRUITINGObjective remission rate (ORR)
The objective response rate will be analyzed according to the RECIST 1.1 standard tumor evaluation.
Time frame: within approximately 3 years
Progression-free survival (PFS)
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
Time frame: within approximately 3 years
Duration of relief (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Time frame: within approximately 3 years
Disease control rate (DCR)
Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
Time frame: within approximately 3 years
Overall survival (OS)
Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
Time frame: within approximately 3 years
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Beijing Cancer Hospital
Beijing, China
RECRUITING