Daraxonrasib

Clinical Trials Overview

4 trials found
About Daraxonrasib

Daraxonrasib is a RAS(ON) inhibitor that directly targets mutant KRAS proteins in solid tumors, including colorectal cancer. This targeted therapy specifically addresses KRAS G12C mutations, which occur in approximately 3-5% of colorectal cancers and have historically been considered "undruggable" targets. The drug works by binding to the active, GTP-bound state of mutant KRAS proteins, offering a novel approach to treating KRAS-driven cancers. Daraxonrasib is being evaluated both as monotherapy and in combination with other agents like immunotherapy drugs for patients with KRAS G12C-mutant solid tumors.

Category Other Medications
Brand Name Not yet branded
Mechanism Daraxonrasib functions as a RAS(ON) inhibitor, meaning it targets the active, GTP-bound conformation of mutant KRAS proteins rather than the inactive GDP-bound state targeted by traditional KRAS G12C inhibitors. This mechanism allows the drug to directly interfere with oncogenic KRAS signaling pathways that drive tumor growth and survival. By binding to active KRAS, daraxonrasib disrupts downstream signaling cascades including the RAF-MEK-ERK and PI3K-AKT pathways that are critical for cancer cell proliferation.
4
Total Trials
3
Recruiting
0
Active
0
Completed
1,738
Total Enrollment
15
Countries
Active sites for Daraxonrasib
Recruiting sites 15 countries
Phase:
NCT07397338 Phase 1 Recruiting 370 patients
Start: Jan 2026
End: May 2029
INTERVENTIONAL
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.
United States
NCT07349537 Phase 1 Recruiting 574 patients
Start: Jan 2026
End: Oct 2028
INTERVENTIONAL
Medications: Cetuximab Daraxonrasib RMC-5127
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid t...
United States
NCT06128551 Phase 1 Recruiting 534 patients
Start: Nov 2023
End: Jun 2029
INTERVENTIONAL
Medications: Daraxonrasib Elironrasib
This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.
United States, France, Germany, Italy, Netherlands, Puerto Rico, Spain
NCT07492680 Phase 2 Not yet recruiting 260 patients
Start: Jul 2026
End: May 2032
INTERVENTIONAL
This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is...
United States, Belgium, Canada, China, France, Germany, Hong Kong, Ireland, Italy, Japan, Norway, So