NCT05135715招募中2 期
A Single-arm, Multicentre, Open Phase Ⅱa Clinical Study of RC48-ADC in the Treatment of HER2 Variant (Mutation, Amplification, Overexpression) Advanced Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Objective remission rate (ORR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •According to the RECIST 1.1 standard, there is at least one measurable lesion.
排除标准
- •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.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
- •Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
研究组 & 干预措施
RC48-ADC
Experimental
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).
干预措施: RC48-ADC (Drug)
结局指标
主要结局
Objective remission rate (ORR)
时间窗: within approximately 3 years
The objective response rate will be analyzed according to the RECIST 1.1 standard tumor evaluation.
次要结局
- 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)
研究者
研究点 (4)
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