Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

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a study on Lung Cancer Non-Small Cell Lung Cancer Colorectal Cancer Pancreatic Ductal Adenocarcinoma Solid Tumor Colorectal Tumor Lung Tumor Colon Cancer Pancreatic Cancer Pancreatic Neoplasms Gastrointestinal Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
study ends around

Description

Summary

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.

Official Title

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors

Details

This is an open-label, multicenter, Phase 1/1b study of RMC-9805, a selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two arms: RMC-9805 monotherapy arm and RMC-9805 plus RMC-6236 combination arm. Both arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion.

Keywords

Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors, KRAS G12D (ON), NSCLC, CRC, PDAC, Non-small Cell Lung Cancer, Lung Cancer, Colorectal Cancer, Colon Cancer, Pancreatic Cancer, Metastatic Cancer, Pancreatic Ductal Adenocarcinoma, Pancreatic Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms, KRAS, Colonic Neoplasms, Non-Small-Cell Lung Carcinoma, Lung Neoplasms, Neoplasm Metastasis, RMC-9805, RMC-6236

Eligibility

You can join if…

Open to people ages 18 years and up

  • Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation
  • Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
  • ECOG performance status 0 or 1
  • Adequate organ function

You CAN'T join if...

  • Primary central nervous system (CNS) tumors
  • Known or suspected leptomeningeal or active brain metastases or spinal cord compression
  • Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
  • Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)

Other inclusion/exclusion criteria may apply.

Locations

  • University of California, Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Sarah Cannon Research Institute at Mary Crowley accepting new patients
    Dallas Texas 75230 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revolution Medicines, Inc.
Links
Sign up for this study
ID
NCT06040541
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 604 study participants
Last Updated
Contact us about this trial