NCT05332574招募中1 期
A Phase I/II, First-in-Human, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of a Trispecific EGFR/cMET/cMET Antibody GB263T in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious AEs
研究概览
简要总结
This is a Phase 1/2 study of GB263T in participants with advanced NSCLC and other solid tumor. The study will consist of a dose-escalation and expansion stage to determine RP2D (Phase 1), and an extension stage (Phase 2) where participants will be enrolled into indication-specific cohorts.
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
- •≥18 years of age.
- •Subjects with histologically or cytologically confirmed metastatic or unresectable advanced NSCLC or other solid tumors who have progressed on prior standard therapy, have been intolerant to prior standard therapy, or have refused all other currently available therapeutic options.
- •Subjects must have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •An expected survival time is ≥3 months.
- •Adequate organ function.
- •Subjects in Phase II must agree to provide pre-treatment tumor tissue samples.
排除标准
- •Subjects who have had prior chemotherapy, targeted cancer therapy, immunotherapy, or any investigational anti-cancer treatment within 2 weeks or five half-lives of the treatment (whichever is longer), prior to the first administration of the study drug.
- •Toxicity (excluding alopecia, peripheral neuropathy, and hypothyroidism) that did not return to class 0 or class 1 of NCI CTCAE V5.0 from prior antitumor therapy prior to the first administration of the study drug.
- •Prior radical radiation therapy completed within 4 weeks prior to the first administration of the study drug.
- •Subjects with untreated symptomatic brain metastases.
- •History of interstitial lung disease (ILD).
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •Received live virus vaccination within 30 days of first dose of study treatment.
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious AEs
时间窗: Screening up to follow-up (30 [+7] days after the last dose)
DLT in Phase I
时间窗: During Cycle 1 (up to 28 days)
ORR in Phase II
时间窗: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
次要结局
- Cmax(At predefined intervals up to 449 days)
- DOR(Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose))
- Rac_AUC0-τ(At predefined intervals up to 449 days)
- AUC0-τ(At predefined intervals up to 449 days)
- Tmax(At predefined intervals up to 449 days)
- AUC0-last(At predefined intervals up to 449 days)
- t1/2(At predefined intervals up to 449 days)
- Cmin(At predefined intervals up to 449 days)
- Rac_Cmax(At predefined intervals up to 449 days)
- ADA(Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose))
- OS(Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose))
- PFS(Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
- CBR(Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose))
研究者
研究点 (8)
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