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Comparing Daraxonrasib Alone or Combined with Gemcitabine and Paclitaxel Albumin‑Bound vs Standard Chemotherapy in Patients with Metastatic Pancreatic Adenocarcinoma

Verified siteRegistered drugNo placebo
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What is this trial about?

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

Metastatic Pancreatic Adenocarcinoma is a type of pancreatic cancer that has spread beyond the pancreas. The study evaluates an oral tablet called daraxonrasib, an intravenous chemotherapy drug known as gemcitabine, and an intravenous infusion of paclitaxel albumin-bound. Three treatment groups are used: one receives the oral tablet alone, a second receives the tablet together with the two intravenous drugs, and a third receives the two intravenous drugs alone, which is the current standard first‑line therapy.

The purpose of the study is to compare how well the new oral tablet, alone or combined with standard chemotherapy, works against standard chemotherapy alone in controlling the cancer. Participants are randomly assigned to one of the three groups and receive treatment in repeating 28‑day cycles. During the study, regular doctor visits, imaging scans, blood tests, and quality‑of‑life questionnaires are performed to track disease status and any side effects. Treatment continues until the cancer grows, side effects become unacceptable, or the study ends after about two years.

Randomly assigned means the chance decides which group a participant joins, helping to keep the comparison fair. Open‑label indicates that both the medical team and participants know which treatment is being given. A cycle refers to a set period of treatment followed by a short rest, typically one month. Progression means the cancer is getting larger or spreading, which doctors watch for using standard imaging methods.

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 assignment to treatment arm

    After joining the study, you will be randomly placed into one of three groups: daraxonrasib alone, daraxonrasib together with gemcitabine and nab‑paclitaxel, or gemcitabine plus nab‑paclitaxel alone. the assignment determines which medicines you will receive during the trial.

  2. Step 2

    Baseline assessments

    Before any medication is given, a series of tests will be performed. these include a physical examination, blood tests, imaging scans of the pancreas, and questionnaires about your current health and quality of life. the results provide a reference point for later comparisons.

  3. Step 3

    Start of first treatment cycle

    Treatment is organized into cycles that last 28 days each. the first cycle begins after the baseline assessments are completed.

  4. Step 4

    Oral daraxonrasib tablet (if assigned)

    If you are in the daraxonrasib monotherapy arm or the combination arm, you will take one tablet containing 300 mg of daraxonrasib by mouth each day. the tablet is taken once daily throughout every 28‑day cycle, continuing until the study ends or your doctor decides to stop the medication.

  5. Step 5

    Intravenous infusion of gemcitabine and nab‑paclitaxel (if assigned)

    If you are in the combination arm or the comparator arm, you will receive an infusion through a vein on day 1 of each 28‑day cycle. the infusion contains:

    - gemcitabine at a dose of 1000 mg per square meter of body‑surface area,

    - nab‑paclitaxel at a dose of 125 mg per square meter of body‑surface area.

    Both medicines are given together during the same visit. the infusion is administered by trained staff and takes several hours.

  6. Step 6

    Regular clinic visits for safety monitoring

    You will attend clinic appointments at the beginning of each cycle and may have additional visits as needed. during these visits, blood will be drawn to check organ function, vital signs such as blood pressure and temperature will be measured, and you will be asked about any side effects. questionnaires about pain and overall health may also be completed.

  7. Step 7

    Blood sampling for daraxonrasib concentration (selected cycles)

    If you receive daraxonrasib, blood samples will be collected before taking the morning tablet (pre‑dose trough) and after the tablet (post‑dose) at specific times up to day 1 of cycle 5. these samples help researchers understand how the drug behaves in the body.

  8. Step 8

    Imaging assessments to evaluate disease status

    Periodic scans, such as CT or MRI, will be performed approximately every 8 weeks to determine whether the cancer is responding to treatment, stable, or progressing. the results are compared with the baseline images.

  9. Step 9

    Continuation of treatment cycles

    The 28‑day cycles repeat as long as the cancer does not grow, you do not develop unacceptable side effects, and the study has not reached its maximum follow‑up time of about 2 years. each new cycle follows the same medication schedule described in steps 4 and 5.

  10. Step 10

    Study completion and follow‑up

    When treatment stops—either because of disease progression, side effects, or the end of the study period—you will continue to be monitored for overall survival and long‑term safety. follow‑up visits may occur every few months for up to approximately 2 years after the last dose.

Who can join the trial?

8 criteria

  • You must be at least 18 years old and agree to join the study after it is fully explained to you (informed consent means you understand the trial and voluntarily agree to take part).
  • Your ability to carry out daily activities must be rated as ECOG performance status 0 or 1 (a score where 0 means fully active and 1 means you can do light work but have some limitation).
  • You need to have pancreatic cancer confirmed by a lab test of a tissue sample (histologically or cytologically confirmed means doctors have looked at cells from your tumor under a microscope to be sure of the diagnosis).
  • Your cancer must have spread to other parts of the body (metastatic disease) and this spread must have been diagnosed no more than 6 weeks before you sign the consent form.
  • You must have a known result for the RAS mutation status (a test that shows whether a specific gene is changed or normal, which can affect treatment choices).
  • Your tumors need to be measurable on scans according to RECIST v1.1 (a standard set of rules doctors use to measure tumor size on imaging studies).
  • You must have sufficient function of major organs (adequate organ function), including bone marrow, liver, kidneys, and blood clotting ability, as shown by routine blood tests.
  • You must be able to swallow and take medicines by mouth (oral medications).

Who cannot join the trial?

5 criteria

  • Having already received systemic anticancer therapy (cancer medicines that travel throughout the whole body) for cancer that has spread (metastatic disease), or having taken any RAS‑targeted therapy (drugs that aim at a specific gene called RAS) in the past.
  • Having an active or known history of untreated central nervous system (brain or spinal cord) metastatic disease (cancer that has spread to these areas) that has not been treated.
  • Having any health condition that could make it difficult to swallow or for the body to absorb the study medication (absorb = get the drug into the bloodstream).
  • Having had a major operation (big surgery) within the 28 days before being assigned to a treatment group (randomization).
  • Being unable or unwilling to follow the study’s required visits and procedures (protocol‑required).
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Investigated drugs

  • Daraxonrasib

    is an oral experimental drug that targets a specific protein involved in the growth of pancreatic cancer cells. In this study it is being tested alone and also together with other chemotherapy medicines to see if it can slow tumor growth and help patients live longer.

  • Gemcitabine

    is a chemotherapy medicine given through an IV. It works by interfering with the DNA of cancer cells, which stops them from multiplying. In the trial it is used with other drugs as a standard treatment for pancreatic cancer.

  • Nab‑paclitaxel

    (albumin‑bound paclitaxel) is an IV chemotherapy that delivers the cancer‑killing drug paclitaxel attached to a protein called albumin. This helps the drug get into the tumor more effectively. In the study it is given with gemcitabine as a common therapy, and also combined with daraxonrasib to test a new treatment approach.

What is already known about the treatment

  • Daraxonrasib (RMC-6236)

    This experimental drug is taken as a 300 mg oral tablet. It is currently being studied in clinical trials and is not yet approved for general medical use. The medication is being tested for patients with metastatic pancreatic adenocarcinoma. It works by blocking the KRAS G12D protein, which stops signals that make cancer cells grow, and it belongs to the class of small‑molecule KRAS inhibitors.

  • Abraxane (paclitaxel albumin‑bound)

    This chemotherapy is given by intravenous infusion, typically at a dose of 125 mg/m². It is an approved treatment for pancreatic cancer and several other cancers such as breast and lung cancer. The drug binds to and stabilizes microtubules, which prevents cancer cells from dividing, and it is classified as a taxane chemotherapy in an albumin‑bound formulation.

  • Gemcitabine

    This medication is administered as an intravenous infusion, usually at 1000 mg/m². It is an approved chemotherapy for metastatic pancreatic adenocarcinoma and other solid tumors. Gemcitabine mimics a building block of DNA, interfering with DNA synthesis and causing cancer cells to die, and it belongs to the antimetabolite class of chemotherapy agents.

Investigated diseases

Metastatic Pancreatic Adenocarcinoma - Metastatic pancreatic adenocarcinoma is a cancer that starts in the gland that makes digestive enzymes and has spread to other parts of the body. It begins as a growth in the pancreas that can become invasive, allowing cancer cells to travel through the bloodstream or lymph system. As the disease progresses, new tumors may form in the liver, lungs, or other organs. The spread can cause the original tumor and secondary sites to grow larger, affecting organ function. Symptoms may increase as more tissue is involved, and the disease can continue to expand without effective control.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-525088-34-00Protocol codeRMC-6236-303Estimated enrolment900 patientsSponsorRevolution Medicines Inc.

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