Clinical Trials

All registrational and early-phase studies of daraxonrasib: design, population, primary endpoints and current status

Phase 3 studies 4

RASolute 302

ClinicalTrials.gov: NCT06625320

Read out (positive)

Indication: Metastatic pancreatic ductal adenocarcinoma (second line)
Population: Adults with metastatic PDAC that progressed after first-line chemotherapy
Design: Global, randomised, open-label, multicentre; 1:1 to daraxonrasib 300 mg QD or investigator's-choice chemotherapy
Comparator: One of 4 investigator's-choice standard chemotherapy regimens (e.g. gemcitabine + nab-paclitaxel, liposomal irinotecan + 5-FU/LV)
Primary endpoint: Overall survival (OS) and progression-free survival (PFS) — RAS G12-mutant and overall populations
Planned enrollment: 500 patients

Primary and key secondary endpoints met, announced April 2026. Overall population median OS 13.2 vs 6.7 months (HR 0.40); median PFS 7.2 vs 3.6 months (HR 0.49); ORR 30% vs 11%. This trial was the basis for the FDA approval in August 2026.

RASolute 303

ClinicalTrials.gov: NCT07491445

Recruiting

Indication: Metastatic pancreatic ductal adenocarcinoma (first line)
Population: Treatment-naïve adults with metastatic PDAC
Design: Randomised, open-label, multicentre; daraxonrasib monotherapy and daraxonrasib plus chemotherapy vs standard chemotherapy
Comparator: Standard first-line chemotherapy (e.g. gemcitabine + nab-paclitaxel)
Primary endpoint: Overall survival (OS)

RASolute 304

ClinicalTrials.gov: NCT07252232

Recruiting

Indication: Resectable pancreatic ductal adenocarcinoma (adjuvant)
Population: Patients with PDAC after surgical resection and standard perioperative chemotherapy
Design: Randomised, multicentre; adjuvant daraxonrasib monotherapy vs observation
Comparator: Standard of care (observation)
Primary endpoint: Disease-free survival (DFS)

RASolve 301

ClinicalTrials.gov: NCT06881784

Recruiting

Indication: RAS-mutant non-small cell lung cancer (previously treated)
Population: Locally advanced or metastatic RAS-mutant NSCLC after 1–2 prior lines of therapy
Design: Randomised, open-label, multicentre; daraxonrasib vs docetaxel
Comparator: Docetaxel
Primary endpoint: Overall survival (OS)
Planned enrollment: ~420 patients

First patient dosed May 14, 2025. The supporting Phase 1/2 NSCLC data were published in NEJM in September 2026 (ORR 42%, mPFS 8.3 months, mOS 16 months).

Phase 1/2 studies 4

RMC-6236-001

ClinicalTrials.gov: NCT05379985

Active, not recruiting

Indication: Advanced RAS-mutant solid tumors
Population: Patients with advanced solid tumors harbouring KRAS/NRAS/HRAS mutations (PDAC, NSCLC, CRC and others)
Design: First-in-human, open-label, dose escalation and cohort expansion; daraxonrasib monotherapy
Comparator: None (single arm)
Primary endpoint: Safety, tolerability, recommended Phase 2 dose, objective response rate

Provided the pancreatic cancer data underlying Breakthrough Therapy Designation and the NSCLC data published in NEJM; the foundation of the entire Phase 3 program.

Elironrasib ± Daraxonrasib

ClinicalTrials.gov: NCT06128551

Recruiting

Indication: KRAS G12C-mutant solid tumors
Population: Patients with advanced KRAS G12C-mutant solid tumors
Design: Open-label; elironrasib (RMC-6291) monotherapy, daraxonrasib monotherapy and the combination
Comparator: None (single arm / multiple cohorts)
Primary endpoint: Safety, recommended dose, ORR

RMC-LUNG-101

ClinicalTrials.gov: NCT06162221

Recruiting

Indication: Advanced RAS-mutant non-small cell lung cancer
Population: Patients with advanced RAS-mutant NSCLC
Design: Open-label, multi-cohort; RAS(ON) inhibitors alone and combined with standard therapy (including immunotherapy and chemotherapy)
Comparator: —
Primary endpoint: Safety, ORR

RAS(ON) + Ivonescimab

ClinicalTrials.gov: NCT07397338

Recruiting

Indication: RAS-mutant solid tumors
Population: Patients with advanced RAS-mutant solid tumors
Design: Open-label; RAS(ON) inhibitors including daraxonrasib combined with the PD-1 × VEGF bispecific antibody ivonescimab
Comparator: —
Primary endpoint: Safety, ORR

Note: trial status follows ClinicalTrials.gov and sponsor announcements and is updated periodically. Patients interested in a trial should speak to their treating physician.