NCT06619587招募中1 期
A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 410
- 试验地点
- 68
- 主要终点
- Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale
研究概览
简要总结
This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
- •Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
排除标准
- •Malabsorption or other condition that would interfere with enteral absorption
- •Active brain metastases
- •Clinically significant cardiovascular dysfunction or liver disease
研究组 & 干预措施
Phase I Arm B
Experimental
Dose escalation and expansion arm
干预措施: Phase I Arm B (Drug)
Phase I Arm A
Experimental
Dose escalation and expansion arm
干预措施: Phase I Arm A (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale
时间窗: 4 Years
Percentage of Participants with Dose Limiting Toxicity
时间窗: 4 Years
次要结局
- Plasma Concentrations of GDC-7035 at Specified Timepoints(4 Years)
- Blood Concentrations of GDC-7035 at Specified Timepoints(4 Years)
- Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal(4 Years)
- Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal(4 Years)
- Objective Response Rate Among Participants(4 Years)
- Duration of Response Among Participants(4 Years)
- Median Progression Free Survival Time Among Participants(4 Years)
研究者
研究点 (68)
Loading locations...
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