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.
Primary Objective:
To compare the effect of zoldonrasib plus Investigator's choice of chemotherapy (mFFX or GnP) versus placebo plus Investigator's choice of chemotherapy (mFFX or GnP).
Secondary Objectives:
1. To compare the effect of zoldonrasib plus Investigator's choice of chemotherapy (mFFX or
GnP) versus placebo plus Investigator choice of chemotherapy (mFFX or GnP).
2. To assess the safety and tolerability of Zoldonrasib plus the Investigator's choice of chemotherapy (mFFX or GnP) versus placebo plus Investigator's choice of chemotherapy (mFFX or GnP).
3. To compare the effect on HRQoL of treatment with zoldonrasib plus Investigator's choice of chemotherapy (mFFX or GnP) versus placebo plus Investigator's choice of chemotherapy (mFFX or GnP).
4. To characterize the PK of zoldonrasib plus Investigator's choice of chemotherapy (mFFX or GnP.)
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Monmouth Medical Center
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Somerset
- Rutgers University
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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