RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 670
- 试验地点
- 9
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.
详细描述
This is a Phase 3, global, randomized, double-blind study designed to evaluate whether treatment with zoldonrasib in combination with Investigator choice of chemotherapy will improve progression-free survival or overall survival compared to placebo in combination with Investigator choice of chemotherapy when given to patients with previously untreated, 1L metastatic KRAS G12D-mutated pancreatic adenocarcinoma. Choice of chemotherapy (mFFX or GnP) will be at the discretion of the Investigator.
Patients will be randomized to one of two arms: zoldonrasib + Investigator choice of chemotherapy (Arm A) or placebo + Investigator choice of chemotherapy (Arm B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Chemotherapy administration will be open label. This study is double-blind with respect to zoldonrasib versus placebo and treatment assignments will remain blinded to the Investigator, study center staff, patient, Sponsor, and study vendors.
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
- •At least 18 years old and has provided informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Histologically or cytologically confirmed pancreatic adenocarcinoma.
- •Diagnosis of metastatic disease ≤ 6 weeks prior to screening.
- •Documented KRAS G12D mutation status.
- •Measurable disease per RECIST v1.
- •Adequate organ function (bone marrow, liver, kidney, coagulation).
- •Able to take oral medications.
排除标准
- •Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting.
- •Prior systemic RAS-targeted therapy any time prior to randomization.
- •Presence of other known driver mutations with approved targeted therapies
- •Active or known history of untreated central nervous system metastatic disease.
- •Any conditions that may affect the ability to take or absorb study drug.
- •Major surgery within 28 days prior to randomization.
- •Patient is unable or unwilling to comply with protocol-required study visits or procedures.
研究组 & 干预措施
Arm A: zoldonrasib + chemotherapy
study drug in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Oxaliplatin (Drug)
Arm A: zoldonrasib + chemotherapy
study drug in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Gemcitabine (GEM) (Drug)
Arm B: placebo + chemotherapy
placebo in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Gemcitabine (GEM) (Drug)
Arm B: placebo + chemotherapy
placebo in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Placebo (Drug)
Arm A: zoldonrasib + chemotherapy
study drug in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Zoldonrasib (Drug)
Arm A: zoldonrasib + chemotherapy
study drug in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Leucovorin (Calcium Folinate) (Drug)
Arm B: placebo + chemotherapy
placebo in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Leucovorin (Calcium Folinate) (Drug)
Arm A: zoldonrasib + chemotherapy
study drug in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Nab-paclitaxel (Drug)
Arm A: zoldonrasib + chemotherapy
study drug in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Irinotecan (Drug)
Arm B: placebo + chemotherapy
placebo in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Irinotecan (Drug)
Arm A: zoldonrasib + chemotherapy
study drug in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: 5-Fluorouracil (Drug)
Arm B: placebo + chemotherapy
placebo in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Oxaliplatin (Drug)
Arm B: placebo + chemotherapy
placebo in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: 5-Fluorouracil (Drug)
Arm B: placebo + chemotherapy
placebo in combination with Investigator choice chemotherapy (mFFX or GnP)
干预措施: Nab-paclitaxel (Drug)