Early clinical research
Daraxonrasib (RMC-6236) — RAS(ON) inhibitor in advanced RAS-mutant solid tumors
A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
- Phase
- Phase I/II
- Recruitment
- Recruiting
- Results maturity
- Interim analysis
- Publication
- Peer-reviewed
- Regulatory approval
- No regulatory approval
- NCT
- NCT05379985
- Registry checked
- 2026-10-29
- Editorial update
- 2026-10-29
Not a treatment recommendation. Experimental or ongoing research does not by itself replace standard care.
For patients
What is being studied? An oral RAS-targeted drug was first studied in early-phase cohorts. Confirmatory phase III (RASolute 302) results and US approval are summarized on a separate card.
Why promising? Oral RAS(ON) multiselective inhibitor with antitumor activity signal in previously treated PDAC.
What is not proven? Phase III randomized OS/PFS superiority was answered in RASolute 302 (Landmark Atlas + Ufuk RASolute card). This early-phase card alone does not imply approval or first-line use; toxicity and country access remain separate.
Is this standard care today? This listing alone does not replace standard care; approval and guideline context require clinician judgment.
For clinicians
NEJM 2026 early phase: previously treated RAS-mutant PDAC (n=168, ≤300 mg); grade ≥3 TRAE ~30%; ORR 35% in a small G12 2L 300 mg subgroup. Phase III superiority and FDA approval → RASolute 302 card.
Cancer / population: Pancreas, Multiple / solid tumors — İleri RAS-mutant solid tümörler; PDAC kohortu vurgulu
Intervention: Oral daraxonrasib (RMC-6236)
Primary endpoint: Güvenlik / DLT; antitümör aktivite ikincil
Source-verified summary: NEJM 2026 PDAC odak: 2L G12 @300 mg ORR 35% (95% CI 17–56); mPFS 8.5 ay; mOS 13.1 ay (altgrup).
Limitations: Doğrulayıcı faz III ayrı; altgrup ORR küçük örneklem.