A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of QTX3046 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 5
- 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 and tolerability of QTX3046 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 G12D 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: QTX3046 monotherapy dose escalation
QTX3046 will be administered orally at escalating doses as defined in the protocol based on dose level assignment
干预措施: QTX3046 (Drug)
Part 1b: QTX3046 dose escalation in combination with cetuximab
QTX3046 will be administered orally at escalating doses as defined in the protocol in combination with intravenous cetuximab based on dose level assignment
干预措施: QTX3046 (Drug)
Part 1b: QTX3046 dose escalation in combination with cetuximab
QTX3046 will be administered orally at escalating doses as defined in the protocol in combination with intravenous cetuximab based on dose level assignment
干预措施: Cetuximab (Combination Product)
Part 2: QTX3046 monotherapy dose expansion
QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) based on cohort assignment
干预措施: QTX3046 (Drug)
Part 3: QTX3046 dose expansion in combination with cetuximab
QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) in combination with intravenous cetuximab based on cohort assignment
干预措施: QTX3046 (Drug)
Part 3: QTX3046 dose expansion in combination with cetuximab
QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) in combination with intravenous 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
- Duration of response (DoR)(up to 2 years)
- Area under the plasma concentration-time curve (AUC) of QTX3046(up to 2 years)
- Peak plasma concentration of QTX3046 (Cmax)(up to 2 years)
- Objective response rate (ORR)(up to 2 years)