Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Overview
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.
Detailed Description
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).
Who Can Participate
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.
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.
Disclaimer
This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.
Participation decisions can be made only after review by the study team and your treating clinician.