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A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (modified FOLFIRINOX or Gemcitabine plus Nab-paclitaxel) with or without Zoldonrasib (RMC-9805) as First-line Treatment in Patients with Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma (RASolute 305)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524928-21-00
Enrollment
85
Registered
2026-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Adenocarcinoma

Brief summary

PFS, defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by Investigator, OS, defined as the time from randomization until death from any cause

Detailed description

PFS, defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by BICR, Objective response of PR or CR per RECIST v1.1, as assessed by Investigator and BICR, DOR, defined as the time from first evidence of objective response (PR or CR) per RECIST v1.1 to disease progression or death due to any cause, whichever occurs first, as assessed by Investigator and BICR, Incidence and severity of TEAEs, TRAEs, and SAEs, Clinically significant changes in laboratory test values and vital signs, Change from baseline on the EORTC-QLQ-PAN26 pain scale, Change from baseline on the EORTC-QLQ-C30 global health status score, Predose and postdose blood concentrations of zoldonrasib

Interventions

DRUGRMC-9805 Matching Placebo

Sponsors

Revolution Medicines Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
PFS, defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by Investigator, OS, defined as the time from randomization until death from any cause

Secondary

MeasureTime frame
PFS, defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by BICR, Objective response of PR or CR per RECIST v1.1, as assessed by Investigator and BICR, DOR, defined as the time from first evidence of objective response (PR or CR) per RECIST v1.1 to disease progression or death due to any cause, whichever occurs first, as assessed by Investigator and BICR, Incidence and severity of TEAEs, TRAEs, and SAEs, Clinically significant changes in laboratory test values and vital signs, Change from baseline on the EORTC-QLQ-PAN26 pain scale, Change from baseline on the EORTC-QLQ-C30 global health status score, Predose and postdose blood concentrations of zoldonrasib

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 26, 2026