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.
Who Can Participate?
Eligibility
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 Range
18-110
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Mettu
Protocol Number
PRO00120109
NCT ID
NCT07621718
Phase
III
Enrollment Status
Open to Enrollment