A Phase 1 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GS-1206 in Adults With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 302
- 试验地点
- 6
- 主要终点
- Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
研究概览
简要总结
The goal of this clinical study is to learn more about the study drug GS-1206, including its safety, tolerability, and antitumor activity in adult participants with solid tumors.
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
- •All individuals must have a tumor with protocol-specified mutation as determined by local health-authority approved test.
- •For Part A (including backfill cohorts): Individuals with histologically confirmed advanced or metastatic solid tumors who have progressed following treatment in the advanced or metastatic setting known to confer clinical benefit, unless the individual refused, is intolerant to, or is not eligible for standard-of-care (SOC) treatment.
- •For Part B dose expansion, individuals with protocol-specified tumor types will be enrolled.
排除标准
- •Use of any of the therapies listed below within the specified time frames:
- •Investigational drugs (drugs not marketed for any indication) within 28 days prior to Cycle 1 Day
- •Anticancer biologic agent or immunotherapy within 28 days prior to Cycle 1 Day
- •Anticancer chemotherapy or targeted approved small molecule therapy within 21 days prior to Cycle 1 Day 1, or 42 days for nitrosoureas or mitomycin.
- •Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started within 14 days prior to planned Cycle 1 Day 1 are not permitted. Exceptions: hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started at least 14 days prior to Cycle 1 Day
- •Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal/biliary stent, biopsy) within 28 days prior to Cycle 1 Day 1, and any toxicity or complications have recovered to Grade 1 or less.
- •Radiation therapy within 21 days prior to Cycle 1 Day
- •Exception: limited (eg, pain palliation) radiation therapy is allowed if any radiation associated toxicity is resolved to Grade 1 or less, and the radiation is not administered to a target lesion.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part A: Dose Escalation
Participants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles.
干预措施: GS-1206 (Drug)
Part B: Dose Expansion
Participants will be enrolled in different indication specific cohorts. Participants will receive GS-1206 monotherapy at the recommended dose one time daily up to 35 cycles.
干预措施: GS-1206 (Drug)
结局指标
主要结局
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
时间窗: First dose up to 21 days post first dose
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
时间窗: First dose date up to 30 days post last dose (Up to 3 years)
Percentage of Participants Experiencing Clinical Laboratory Abnormalities Based National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
时间窗: First dose date up to 30 days post last dose (Up to 3 years)
次要结局
- Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites(Up to 2 years)
- Plasma Concentrations of GS-1206 and its Metabolites After Single Dose and Repeated Dose Administration(Predose and postdose up to end of treatment (up to 2 years))
- PK Parameter: Tmax of GS-1206 and its Metabolites(Up to 2 years)
- PK Parameter: AUC0-24h of GS-1206 and its Metabolites(Up to 2 years)
- Objective Response Rate (ORR)(Up to 3 years)
- Duration of Response (DOR)(Up to 3 years)
- Best Overall Response (BOR)(Up to 3 years)
- Progression-Free Survival (PFS)(Up to 3 years)
- Disease Control Rate (DCR)(Up to 3 years)