A Single-arm, Multicentre, Open Phase Ⅱa Clinical Study of RC48-ADC in the Treatment of HER2 Variant (Mutation, Amplification, Overexpression) Advanced Melanoma
Overview
- Phase
- Phase 2
- Intervention
- RC48-ADC
- Conditions
- Melanoma, Stage II
- Sponsor
- RemeGen Co., Ltd.
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- Objective remission rate (ORR)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntary agreement to provide written informed consent.
- •Male or female, Age ≥ 18 years.
- •Predicted survival ≥ 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •All female subjects will be considered to be of child-bearing potential unless participants are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
- •Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
- •Adequate organ function.
- •All subjects must be histologically confirmed, non-resectable stage III or metastatic melanoma, except for patients with uveal or ocular melanoma.
- •The subject has experienced disease progression or intolerance after receiving standard treatment in the past; Patients with disease progression within 6 months after receiving neoadjuvant or adjuvant chemotherapy regimens can be included in the clinical study.
- •The HER2 IHC test result is IHC 2+ or IHC 3+, the subject's previous test results (confirmed by the investigator) or the research center's test results are acceptable; the subject can provide the Specimen of primary or metastatic tumor for HER2 review/judgment.
Exclusion Criteria
- •Known hypersensitivity to Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection.
- •History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
- •Pleural or abdominal effusion with clinical symptoms that requires ongoing treatment.
- •Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
- •History of major surgery within 4 weeks of planned start of trial treatment.
- •Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
- •Toxicity of previous anti-tumor treatment not recovered to CTCAE Grade 0-1 (with exception of Grade 2 alopecia).
- •Pregnancy or lactation.
- •Currently known active infection with HIV or tuberculosis.
- •Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive.
Arms & Interventions
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).
Intervention: RC48-ADC
Outcomes
Primary Outcomes
Objective remission rate (ORR)
Time Frame: within approximately 3 years
The objective response rate will be analyzed according to the RECIST 1.1 standard tumor evaluation.
Secondary Outcomes
- Progression-free survival (PFS)(within approximately 3 years)
- Duration of relief (DOR)(within approximately 3 years)
- Disease control rate (DCR)(within approximately 3 years)
- Overall survival (OS)(within approximately 3 years)