Clinical Trial 24169

• Overview

  Study Title:

  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 (RASolute 305)

  Summary:

  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.

  Objective:

  Primary Objective: * To compare the effect of zoldonrasib plus Investigator choice of chemotherapy (mFFX or GnP) versus placebo plus Investigator choice of chemotherapy (mFFX or GnP) Secondary Objectives: * To compare additional measures of efficacy of treatment with zoldonrasib plus Investigator choice of chemotherapy (mFFX or GnP) versus placebo plus Investigator choice of chemotherapy (mFFX or GnP) * To assess the safety and tolerability of zoldonrasib plus Investigator choice of chemotherapy (mFFX or GnP) versus placebo plus Investigator choice of chemotherapy (mFFX or GnP) * To compare the effect on HRQoL of treatment with zoldonrasib plus Investigator choice of chemotherapy (mFFX or GnP) versus placebo plus Investigator choice of chemotherapy (mFFX or GnP) * To characterize the PK of zoldonrasib plus Investigator choice of chemotherapy (mFFX or GnP)

• Treatments

  Therapies:

  Chemotherapy (NOS); Covalent tri-complex inhibitor that targets the active, GTP-bound form of KRAS G12D

  Medications:

  5-fluorouracil (); CPT-11 (irinotecan); Camptosar (irinotecan); Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); Oxaliplatin (); Zoldonrasib/Placebo (); eloxatin (Oxaliplatin); gemcitabine (); irinotecan (); leucovorin ()

• 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 screening.
  • Documented KRAS G12D mutation status.
  • Measurable disease per RECIST v1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • Able to take oral medications.
  • Additional criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • 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.
  • Additional criteria may apply.

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