Revolu-zoldonrasib vs placebo for KRAS G12D pancreatic cancer (RMC-9805-305) - Clinical Trial
What is the Purpose of this Study?
Participants will take a study pill every day and receive chemotherapy infusions every 1 to 2 weeks. They will also have tumor biopsies, provide blood and urine samples, and undergo regular CT or MRI scans to monitor their cancer during the study.
What is the Condition Being Studied?
Pancreatic cancer
Who Can Participate in the Study?
Participants may be able to join if they are adults with pancreatic adenocarcinoma that has spread to other parts of the body, contains a KRAS G12D mutation, and has not been treated before.
Age Group
Adults
What is Involved?
This study is testing whether the study drug zoldonrasib can help treat cancers with a specific genetic change called KRAS G12D. Researchers want to learn how well the drug works and how safe it is when used with chemotherapy.
Study Details
Full Title
[RMC-9805-305] 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)
Principal Investigator
Niharika B. Mettu, MD, PhD
Medical Oncologist
Protocol Number
IRB:
PRO00120109
NCT:
NCT07621718
Phase
Phase III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Call 919-668-1861
or email gi-oncology-cru@dm.duke.edu