RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Zoldonrasib for Pancreatic Cancer

This study wants to measure the how well it works of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to dummy treatment (placebo) in combination with chemotherapy.

Official registry: https://clinicaltrials.gov/study/NCT07621718 · Revolution Medicines, Inc. · enrollment listed as 670

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Zoldonrasib, Placebo, or Oxaliplatin. The registry lists allocation as randomized. This study wants to measure the how well it works of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to dummy treatment (placebo) in combination with chemotherapy.

They plan to enroll about 670 people at 25 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

RASolute 305: 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

Interventions: Zoldonrasib, Placebo, Oxaliplatin, Leucovorin (Calcium Folinate), 5-Fluorouracil, Irinotecan, Gemcitabine (GEM), Nab-paclitaxel

Primary outcome (registry wording): Progression free survival (PFS)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically or cytologically confirmed pancreatic adenocarcinoma
Diagnosis of metastatic disease ≤ 6 weeks prior to screening
Documented KRAS G12D mutation status
Measurable disease per RECIST v1.1
Adequate organ function (bone marrow, liver, kidney, coagulation)
Able to take oral medications

Who the registry excludes

Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting
Prior systemic RAS-targeted therapy any time prior to randomization
Presence of other known driver mutations with approved targeted therapies
Active or known history of untreated central nervous system metastatic disease
Any conditions that may affect the ability to take or absorb study drug
Major surgery within 28 days prior to randomization

Public study contact (from the registry)

Revolution Medicines Study Director

1-844-2-REVMED

medinfo@revmed.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

25 listed

Mayo Clinic Arizona — Phoenix, Arizona (recruiting)
The University of Arizona Cancer Center-North Campus — Tucson, Arizona (recruiting)
Yale University — New Haven, Connecticut (recruiting)
University of Florida — Gainesville, Florida (recruiting)
Mayo Clinic Florida — Jacksonville, Florida (recruiting)
Moffitt Cancer Center — Tampa, Florida (recruiting)
Piedmont Cancer Institute — Atlanta, Georgia (recruiting)
Piedmont Healthcare — Atlanta, Georgia (recruiting)
University of Chicago Medical Center — Chicago, Illinois (recruiting)
Johns Hopkins University — Baltimore, Maryland (recruiting)
Dana Farber Cancer Institute — Boston, Massachusetts (recruiting)
Mayo Clinic Rochester — Rochester, Minnesota (recruiting)

+ 7 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07621718 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07621718?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07621718?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary