A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 28
- 主要终点
- Number of participants with Dose Limiting Toxicities (DLTs)
研究概览
简要总结
Phase 1 study to determine the safety and tolerability of QTX3034 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
- 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
- •Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation 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 1 prior systemic therapy
- •Evaluable or Measurable disease per RECIST 1.
- •Parts 2 and 3: Measurable disease per RECIST 1.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Adequate organ function
排除标准
- •Prior treatment with a KRAS inhibitor
- •Active brain metastases or carcinomatous meningitis
- •History of other malignancy within 2 years
- •Significant cardiovascular disease
- •Disease or disorder that may pose a risk to patient's safety
- •Other protocol-defined Inclusion/Exclusion Criteria may apply
研究组 & 干预措施
Part 1b: QTX3034 combination with cetuximab dose-escalation
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
干预措施: Cetuximab (Combination Product)
Part 2: QTX3034 monotherapy dose-expansion
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
干预措施: QTX3034 (Drug)
Part 3: QTX3034 combination with cetuximab dose-expansion
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
干预措施: QTX3034 (Drug)
Part 1b: QTX3034 combination with cetuximab dose-escalation
QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
干预措施: QTX3034 (Drug)
Part 1a: QTX3034 monotherapy dose-escalation
QTX3034 will be administered at protocol defined dose based on cohort assignment
干预措施: QTX3034 (Drug)
Part 3: QTX3034 combination with cetuximab dose-expansion
QTX3034 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 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
Number of participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: up to 2 years
Defined 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
次要结局
- Duration of response (DOR)(up to 2 years)
- Objective response rate (ORR)(up to 2 years)
- QTX3034 pharmacokinetic parameters in plasma(up to 2 years)