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First‑line Study of RMC‑9805 with Investigator’s Choice Chemotherapy Drug Combination vs Chemotherapy Alone in Patients with Metastatic KRAS G12D‑Mutated Pancreatic Adenocarcinoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Pancreatic Adenocarcinoma that has spread to other parts of the body and carries a specific genetic change called KRAS G12D. Participants receive a standard chemotherapy regimen chosen by the doctor – either modified FOLFIRINOX or Gemcitabine plus Nab-paclitaxel – and are given either the experimental oral drug Zoldonrasib (identified as RMC-9805) or a matching placebo.

The purpose is to compare how well the cancer is controlled when the experimental drug is added to chemotherapy versus chemotherapy alone. After enrollment, participants are randomly assigned to one of the two groups, take the study medication daily in tablet form, and undergo regular clinic visits for treatment cycles and safety checks. The study continues until the disease progresses, the participant stops treatment, or the study ends, with follow‑up visits to monitor overall health and any side effects.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and treatment assignment

    After enrollment, you will be randomly placed into one of two groups. one group receives the study drug zoldonrasib (named rmc-9805) together with the chosen chemotherapy, and the other group receives a matching placebo with the same chemotherapy.

    You will not know which group you are in because the study is double‑blind.

  2. Step 2

    Baseline assessments

    Before any treatment starts, a series of tests will be done to record your health status. these include a physical exam, blood tests, and imaging scans such as CT or MRI to evaluate the pancreatic cancer.

    The results provide a reference point for later comparisons.

  3. Step 3

    Starting the oral study medication

    You will begin taking an oral tablet of zoldonrasib (rmc-9805) at a dose of 1200 mg each day, unless you were assigned to the placebo group, in which case you will take a tablet that looks the same but contains no active drug.

    The tablet is swallowed with water and should be taken at the same time each day.

  4. Step 4

    Starting investigator‑chosen chemotherapy

    Your doctor will select one of two standard chemotherapy regimens:

    modified folfirinox (a combination of several drugs given intravenously every 2 weeks) or gemcitabine plus nab‑paclitaxel (two drugs given intravenously usually every 3 weeks).

    The chemotherapy is administered in a clinic or infusion center.

  5. Step 5

    Daily oral dosing continues

    You will continue to take the 1200 mg tablet each day for the duration of the study treatment.

    If you experience any side effects, you should inform the study staff, but the dosing schedule remains daily unless instructed otherwise.

  6. Step 6

    Regular monitoring visits

    You will attend clinic visits regularly, typically before each chemotherapy cycle.

    During these visits, blood will be drawn for routine laboratory tests, vital signs (blood pressure, heart rate) will be checked, and you will be asked about any new symptoms or side effects.

  7. Step 7

    Periodic imaging scans

    Imaging scans (such as CT or MRI) will be performed at scheduled intervals, often every 8 weeks, to see whether the cancer is responding to treatment or progressing.

    The scans are read by the study investigators using standard criteria.

  8. Step 8

    Management of side effects

    If you develop side effects, the study team may adjust the dose of the chemotherapy or temporarily hold the oral tablet.

    Any changes will be explained to you and recorded in your study documents.

  9. Step 9

    Continuation of treatment

    Treatment with the oral tablet and chemotherapy will continue as long as the cancer does not worsen and the side effects remain manageable.

    The study protocol allows treatment to stop if disease progression is confirmed or if toxicity becomes unacceptable.

  10. Step 10

    End of treatment and follow‑up

    When treatment ends, you will enter a follow‑up phase during which periodic visits may occur to collect information on overall survival and any long‑term effects.

    These follow‑up visits are less frequent and focus on your health status after the study treatment.

Who can join the trial?

8 criteria

  • You are 18 years old or older (or the legal age to give consent).
  • Your overall health score, called ECOG performance status, is 0 or 1, meaning you are fully active or able to do light work.
  • Doctors have confirmed that you have pancreatic cancer by looking at tissue or cells under a microscope (histology or cytology).
  • The cancer has spread to other parts of the body (metastatic disease) and was first found no more than 6 weeks before the screening visit.
  • Your tumor has a specific genetic change called a KRAS G12D mutation, which was found using a reliable test.
  • You have at least one tumor spot that can be measured on scans according to the rules of RECIST version 1.1.
  • Your blood, liver, and kidney tests show that these organs are working well enough (adequate organ function).
  • You are able to swallow and take medicines by mouth.

Who cannot join the trial?

9 criteria

  • You cannot have had any previous systemic therapy (treatment that goes throughout the whole body) for pancreatic cancer that cannot be removed by surgery (unresectable) and has spread locally (locally advanced) or to other parts of the body (metastatic).
  • You cannot have previously taken medicines that specifically target RAS proteins (including KRAS inhibitors) or other drugs that block the MAPK pathway, which are types of targeted cancer treatments.
  • You cannot have a tumor with other known genetic changes that can be treated with existing targeted medicines, such as a BRAF V600E mutation, high microsatellite instability or mismatch repair deficiency (MSI‑high/dMMR), or NTRK gene fusions.
  • You cannot have a type of pancreatic cancer that is not an adenocarcinoma, such as neuroendocrine tumors or acinar cell carcinoma.
  • You cannot have cancer that has spread to the brain or the lining of the brain and spinal cord (central nervous system metastases or leptomeningeal disease) if it is untreated or causing symptoms.
  • You cannot have serious other health problems that are not under control (clinically significant uncontrolled comorbidities), including heart (cardiovascular), lung (pulmonary), or stomach/intestine (gastrointestinal) conditions that could affect safety or how the drug is absorbed.
  • You cannot have an active infection that is not controlled, such as hepatitis B, hepatitis C, or HIV, unless the infection meets the study’s specific control criteria.
  • You cannot have had a major operation within 28 days before you would be assigned to a treatment group.
  • You cannot be unable or unwilling to attend study visits or follow the required procedures (noncompliance with study visits or procedures).
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Investigated drugs

  • Zoldonrasib (RMC-9805)

    is an oral medication that is being tested to block a specific mutation (KRAS G12D) found in some pancreatic cancers. By targeting this mutation, the drug aims to stop the cancer cells from growing and spreading. In the study, patients take the tablet by mouth as part of their treatment plan.

  • Modified FOLFIRINOX

    is a chemotherapy regimen that combines several drugs—typically oxaliplatin, irinotecan, leucovorin, and fluorouracil—given through an IV. The “modified” version uses lower doses or a different schedule to try to keep side effects more manageable while still attacking the cancer cells. It is one of the standard options for first‑line treatment of advanced pancreatic cancer.

  • Gemcitabine plus Nab‑paclitaxel

    is another chemotherapy approach that mixes two drugs. Gemcitabine is given by IV and works by interfering with the DNA of cancer cells, while Nab‑paclitaxel (a protein‑bound form of paclitaxel) also disrupts cell division. Together they are used to shrink tumors and control disease spread in patients with metastatic pancreatic cancer.

What is already known about the treatment

RMC-9805 - RMC-9805 is taken as a 1200 mg oral tablet taken by mouth. It is an experimental drug currently in Phase 3 clinical trials and has not yet received regulatory approval. The tablet is intended for patients with metastatic pancreatic cancer that has the KRAS G12D mutation, and it is given together with standard chemotherapy. It works by binding to the mutant KRAS protein and blocking the signals that drive cancer cell growth, making it a small‑molecule KRAS G12D inhibitor.

Investigated diseases

Pancreatic adenocarcinoma - Pancreatic adenocarcinoma is a type of cancer that begins in the glandular cells lining the pancreatic ducts. It usually starts as a small growth that can enlarge and invade surrounding tissues such as the duodenum, bile duct, and nearby blood vessels. Over time the tumor may spread to regional lymph nodes and then travel through the bloodstream to distant organs like the liver, lungs, and peritoneum. The disease often progresses silently, with symptoms appearing only after the tumor has grown or spread. As the cancer advances, the affected areas can become larger and cause functional impairment of the pancreas and other organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524928-21-00Protocol codeRMC-9805-305Estimated enrolment661 patientsSponsorRevolution Medicines Inc.

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