Clinical Trial 24134

• Overview

  Study Title:

  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

  Summary:

  The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

  Objective:

  Primary Objective: * To compare the effect of treatment with daraxonrasib monotherapy or daraxonrasib plus GnP versus GnP on: PFS , OS Secondary Objectives: * To compare the effect of treatment with daraxonrasib monotherapy or daraxonrasib plus GnP versus GnP on: Objective Response, DOR * To assess the safety and tolerability of daraxonrasib monotherapy or daraxonrasib plus GnP versus GnP * To characterize the PK of daraxonrasib when administered as monotherapy and in combination with GnP * To compare the effect of daraxonrasib monotherapy or daraxonrasib plus GnP versus GnP on: HRQoL

• Treatments

  Therapies:

  Chemotherapy (NOS); RAS(ON) multi-selective tri-complex inhibitor

  Medications:

  Daraxonrasib (); Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); RMC-6236 (Daraxonrasib); gemcitabine ()

• Inclusion Criteria

  Key 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

  Key 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.

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