Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 304)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Revolution Medicines Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-04-28

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Revolution Medicines, Inc.

External identifiers

EU CT number

2025-523495-23-00

ClinicalTrials.gov

NCT07252232

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Therapy, Safety

To compare the treatment effect of daraxonrasib versus standard of care observation in patients with resected pancreatic ductal adenocarcinoma (PDAC) following completion of neoadjuvant and/or adjuvant chemotherapy

Secondary objectives 6

1. To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC versus standard of care observation on OS (Overall-survival, the time from randomization until death from any cause)
2. To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC versus standard of care observation on DFS per blinded independent central review (per BICR)
3. To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC versus standard of care observation on − DFS rate at 1 year and 2 years (per Investigator and BICR)
4. To compare the effect of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC versus standard of care observation on OS rate at 1 year and 2 years
5. To evaluate the safety and tolerability of treatment with daraxonrasib following completion of neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC
6. To characterize the PK of daraxonrasib

Conditions and MedDRA coding

Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Study design 4 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. At least 18 years old and has provided informed consent.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Histologically confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.
4. Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.
5. Must have completed most recent treatment within the past 12 weeks.
6. Adequate organ function (bone marrow, liver, kidney, coagulation).
7. Documented RAS mutation status.
8. Able to take oral medications.

Exclusion criteria 4

1. Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
2. Any conditions that may affect the ability to take or absorb study drug.
3. Major surgery within 28 days prior to randomization.
4. Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Disease-Free Survival (DFS) per Investigator DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.

Secondary endpoints 6

1. Overall survival (OS) - OS is defined as the time from randomization until death from any cause
2. DFS per blinded independent central review (BICR) - DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per RECIST v1.1 as assessed by BICR
3. DFS Rate at 1 year and 2 years - DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively
4. OS rate at 1 year and 2 years - OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively.
5. Safety and tolerability of daraxonrasib - Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests
6. Pharmacokinetics (PK) - Predose concentration of daraxonrasib

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Revolution Medicines Inc.

Sponsor organisation

Revolution Medicines Inc.

Address

700 Saginaw Drive

City

Redwood City

Postcode

94063-4752

Country

United States

Scientific contact point

Organisation

Revolution Medicines Inc.

Contact name

Revolution Medicines Study Director

Public contact point

Organisation

Revolution Medicines Inc.

Contact name

Revolution Medicines Study Director

Third parties 11

Locations

4 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 55 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications