Health Trials

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 )

ConditionsPancreatic CancerPancreatic Cancer MetastaticPDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma MetastaticPancreatic AdenocarcinomaPancreatic Adenosquamous Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRevolution Medicines, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Zoldonrasib
  • Placebo
  • Oxaliplatin
  • Leucovorin (Calcium Folinate)
  • 5-Fluorouracil
  • Irinotecan
  • Gemcitabine (GEM)
  • Nab-paclitaxel

Treatment groups

670 Participants
are divided into 2 treatment groups

Locations

3
Moffitt Cancer Center33612, TampaFlorida, United States
Piedmont Healthcare30318, AtlantaGeorgia, United States
Johns Hopkins University21287, BaltimoreMaryland, United States

Sponsors and collaborators

Revolution Medicines, Inc.

Lead sponsor

Source ClinicalTrials.gov