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Clinical Trials List

Protocol NumberRMC-6236-303
NCT Number(ClinicalTrials.gov Identfier)NCT07491445
Not yet recruiting

2026-06-01 - 2032-01-17

Phase III

Recruiting5

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/10

Investigators and Locations

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kun-Huei Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 姜乃榕 Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Tzong Chen Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yan-Shen Shan
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Pancreatic Cancer、PDAC - Pancreatic Ductal Adenocarcinoma

Objectives

比較 daraxonrasib 單一療法或 daraxonrasib 加 GnP，相較於 GnP 針對下列各項的治療效果： −PFS −OS

Test Drug

錠劑
靜脈輸注液
靜脈輸注液

Active Ingredient

RMC-6236
GEMCITABINE HYDROCHLORIDE
PACLITAXEL

Dosage Form

110
246
246

Dosage

100mg
40 mg/mL
100 mg

Endpoints

•PFS，定義為從隨機分配起，直至發生試驗主持人依據固體腫瘤反應評估標準第 1.1 版 (RECIST v1.1) 評估之疾病惡化或因任何原因死亡（以先發生者為準）所經過的時間
•OS 定義為從隨機分配起直至因任何原因死亡所經過的時間

Inclution Criteria

Inclusion Criteria:

At least 18 years old and has provided informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically or cytologically confirmed pancreatic adenocarcinoma.
Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
Documented RAS mutation status, either mutant or wild-type.
Measurable disease per RECIST v1.1.
Adequate organ function (bone marrow, liver, kidney, coagulation).
Able to take oral medications.

Exclusion Criteria

Exclusion Criteria:

Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.
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.

The Estimated Number of Participants

  • Taiwan

    45 participants

  • Global

    900 participants

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