Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )

Part of paid clinical trials in Tampa, Florida.

Sponsor
Revolution Medicines, Inc.
Study ID
NCT07621718
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zoldonrasib — DRUG
    oral tablets
  • Placebo — DRUG
    oral tablets
  • Oxaliplatin — DRUG
    IV infusion
  • Leucovorin (Calcium Folinate) — DRUG
    IV infusion
  • 5-Fluorouracil — DRUG
    IV infusion
  • Irinotecan — DRUG
    IV infusion
  • Gemcitabine (GEM) — DRUG
    IV infusion
  • Nab-paclitaxel — DRUG
    IV infusion

Study Details

The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.

Key Dates

First listed
Jun 2, 2026
Start date
May 22, 2026
Status verified
Jul 2026
Primary completion
Dec 30, 2028
Completion
Apr 22, 2030

Study Design

Enrollment
670 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: zoldonrasib + chemotherapy
    study drug in combination with Investigator choice chemotherapy (mFFX or GnP)
  • Placebo Comparator: Arm B: placebo + chemotherapy
    placebo in combination with Investigator choice chemotherapy (mFFX or GnP)

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: Up to approximately 4 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Kim
[email protected]
813-745-3691
Piedmont HealthcareAtlantaGeorgia30318
Mieri
[email protected]
404-425-1777
University of Chicago Medical CenterChicagoIllinois60637
Desgardin
[email protected]
773-834-7188
Johns Hopkins UniversityBaltimoreMaryland21287
Apostol
[email protected]
410-502-7484

Find similar trials in Tampa, FL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Moffitt Cancer Center· Tampa, FLPiedmont Healthcare· Atlanta, GAUniversity of Chicago Medical Center· Chicago, ILJohns Hopkins University· Baltimore, MD

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