Trial comparing treatments for Pancreatic Cancer
Official title 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 )
ClinicalTrials.gov ID: NCT07621718
What this study is testing
What is Zoldonrasib?
Zoldonrasib is an investigational oral tablet being studied as a possible treatment for KRAS G12D‑mutated metastatic pancreatic cancer. It is designed to inhibit the KRAS G12D protein, blocking the RAS signaling pathway that drives tumor growth.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if adding a new drug called zoldonrasib to standard chemotherapy helps patients live longer or better than chemotherapy alone.
- Who it's for
- The study is looking for adults with advanced pancreatic cancer that has spread and has a specific genetic change called KRAS G12D.
- What's involved
- Participants will receive either the new drug plus chemotherapy or a placebo (sugar pill) plus chemotherapy, along with regular medical checkups and tests.
- Time commitment
- The study involves regular visits to the clinic for treatment and monitoring, but the total duration is not specified in the provided text.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years old and has provided informed consent.
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- At least 18 years old and has provided informed consent.
- 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.
- 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.
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- East Brunswick, New Jersey, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Salzburg, Austria
- Florence, Italy
- Padova, Italy
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Tucson, Arizona, United States; New Haven, Connecticut, United States; Gainesville, Florida, United States; Jacksonville, Florida, United States; Tampa, Florida, United States and 16 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.