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 )
Public ClinicalTrials.gov record NCT07621718. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07621718
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 670 participants
Conditions and interventions
Conditions
Interventions
- Zoldonrasib Drug
- Placebo Drug
- Oxaliplatin Drug
- Leucovorin (Calcium Folinate) Drug
- 5-Fluorouracil Drug
- Irinotecan Drug
- Gemcitabine (GEM) Drug
- Nab-paclitaxel Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 22, 2026 (Actual)
- Primary completion
- Dec 30, 2028 (Estimated)
- Completion
- Apr 22, 2030 (Estimated)
- Last update posted
- Oct 13, 2026
2026 – 2030
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | Recruiting |
| The University of Arizona Cancer Center-North Campus | Tucson | Arizona | 85719 | Recruiting |
| Yale University | New Haven | Connecticut | 06511 | Recruiting |
| University of Florida | Gainesville | Florida | 32610 | Recruiting |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| Piedmont Cancer Institute | Atlanta | Georgia | 30318 | Recruiting |
| Piedmont Healthcare | Atlanta | Georgia | 30318 | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | 21287 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | Recruiting |
| Astera Cancer Care | East Brunswick | New Jersey | 08816 | Recruiting |
| Rutgers Cancer University | New Brunswick | New Jersey | 08901 | Recruiting |
| Columbia University Irving Medical Center | New York | New York | 10032 | Recruiting |
| Duke Cancer Center | Durham | North Carolina | 27710 | Recruiting |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07621718, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07621718 live on ClinicalTrials.gov.