A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 237
- 试验地点
- 9
- 主要终点
- Number of participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.
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
- •Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
- •Part 1: Advanced solid tumors with at least one prior systemic therapy.
- •Evaluable and measurable disease per RECIST v1.
- •Part 2 and 3: Measurable disease per RECIST v1.1.
排除标准
- •Active brain metastasis or carcinomatous meningitis
- •Significant cardiovascular disease
- •Active infection requiring intravenous (IV) antibiotics
- •Prior treatment with a KRAS inhibitor
- •Other protocol-defined Inclusion/Exclusion Criteria may apply
研究组 & 干预措施
Part 1a: QTX3544 monotherapy dose escalation
QTX3544 will be administered at protocol defined dose based on cohort assignment
干预措施: QTX3544 (Drug)
Part 1b: QTX3544 dose escalation in combination with cetuximab
QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
干预措施: QTX3544 (Drug)
Part 1b: QTX3544 dose escalation in combination with cetuximab
QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
干预措施: Cetuximab (Combination Product)
Part 2: QTX3544 monotherapy dose expansion
QTX3544 will be administered at protocol defined dose based on cohort assignment
干预措施: QTX3544 (Drug)
Part 3: QTX3544 dose expansion in combination with cetuximab
QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
干预措施: QTX3544 (Drug)
Part 3: QTX3544 dose expansion in combination with cetuximab
QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
干预措施: Cetuximab (Combination Product)
结局指标
主要结局
Number of participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: up to 2 years
Define as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab.
Number of participants with Dose Limiting Toxicities (DLTs)
时间窗: up to 21 days
DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.
次要结局
- Area under the plasma concentration-time curve (AUC) of QTX3544(up to 2 years)
- Peak plasma concentration of QTX3544 (Cmax)(up to 2 years)
- Objective response rate (ORR)(up to 2 years)
- Duration of response (DoR)(up to 2 years)