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A Study of Setidegrasib with Chemotherapy Drug Combination as First‑Line Treatment in Adults with KRAS G12D‑mutated Metastatic Pancreatic Cancer

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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 adults with metastatic pancreatic adenocarcinoma that carries a KRAS G12D mutation, meaning the cancer cells have a specific genetic change that can affect growth. The experimental drug being evaluated is ASP3082, which is given together with one of two standard chemotherapy combinations, mFOLFIRINOX or NALIRIFOX. A placebo (a simple sugar solution) may be used for comparison, and the overall aim is to determine whether adding ASP3082 can extend the time patients live.

Participants are assigned at random to receive either ASP3082 plus chemotherapy or the placebo plus chemotherapy. The study drug is delivered by intravenous infusion, a process where the medication is slowly introduced into a vein. Treatment cycles are repeated every few weeks, and patients are monitored over several months for changes in tumor size, side effects, and overall health status before the study concludes.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and assignment

    After joining the study, you are randomly placed into one of two groups. One group receives the test medicine ASP3082, the other group receives a placebo (dextrose 5% in water solution for infusion). the assignment is double‑blind, meaning neither you nor the treating physician knows which group you are in.

    The randomization also determines which chemotherapy regimen you will receive: either mfollifirinox or nalirifox. both regimens are standard treatments for pancreatic cancer.

  2. Step 2

    First infusion of study drug with chemotherapy

    On the first treatment day you receive an intravenous infusion. The study drug is delivered through a vein. If you are in the test arm, the infusion contains ASP3082 at a dose of 0000 mg (setidegrasib). if you are in the placebo arm, the infusion contains dextrose 5% in water.

    The infusion is given together with the chosen chemotherapy regimen (mfollifirinox or nalirifox) according to the protocol schedule.

  3. Step 3

    Repeated treatment cycles

    You continue to receive the same combination of study drug (ASP3082 or placebo) and chemotherapy at regular intervals. Each cycle follows the same schedule as the first infusion. The exact frequency follows the chemotherapy protocol, typically every two weeks, and continues for as long as the study allows.

    The dose of ASP3082 (0000 mg) remains the same for each infusion. The placebo infusion also remains the same.

  4. Step 4

    Scheduled assessments

    Throughout the trial you attend regular visits for assessments. These include imaging scans to check tumor size, laboratory tests to monitor blood values, and questionnaires that evaluate quality of life.

    The primary goal of the assessments is to measure overall survival and to monitor any side effects.

  5. Step 5

    Monitoring and reporting side effects

    You are asked to report any new symptoms or side effects to the study team. Common monitoring includes checking vital signs, performing electrocardiograms (ECG), and evaluating performance status (how well you can carry out daily activities).

    All reported information is used to assess safety and tolerability of the treatment.

  6. Step 6

    Continuation or discontinuation of treatment

    Treatment continues until one of the following occurs: disease progression (tumor growth), unacceptable side effects, or the end of the study period. The decision to stop treatment is made by the investigator based on the assessments.

    If treatment is stopped, you may still be followed for final evaluations.

  7. Step 7

    Final evaluation

    At the end of the study you undergo a final set of assessments, which include imaging, laboratory tests, and quality‑of‑life questionnaires.

    The results are used to compare overall survival and other outcomes between the ASP3082 group and the placebo group.

Who can join the trial?

6 criteria

  • Must have a tissue diagnosis showing metastatic pancreatic ductal adenocarcinoma (PDAC) with a specific genetic change called KRAS G12D mutation; the test result must be known before joining the study.
  • Must not have any option for surgery or radiation that could cure the cancer.
  • The KRAS G12D mutation must be identified from a tissue sample using a laboratory test.
  • Must have an ECOG performance status of 0 or 1 (a simple scale that measures how well you can carry out daily activities) measured within 7 days before randomization.
  • Must have adequate organ function (blood, liver, kidneys, and other organs must be working well enough for treatment).
  • Must be an adult (usually 18 years of age or older) and can be male or female.

Who cannot join the trial?

6 criteria

  • Having a type of pancreatic cancer called neuroendocrine tumor, acinar pancreatic carcinoma, or a pancreatic cancer that shows squamous/adenosquamous features (special patterns of cancer cells) means you cannot join the study.
  • If you have a known low or missing level of the enzyme DPD (dihydropyrimidine dehydrogenase), which helps break down certain chemotherapy drugs, you are not eligible.
  • Having two copies (called homozygous) of a changed version of the gene UGT1A1, which can affect how your body processes medicines, excludes you from participation.
  • Receiving any radiotherapy (radiation treatment) within the 14 days before the study starts makes you ineligible.
  • Having taken other cancer medicines (called systemic therapy) for your metastatic pancreatic cancer, except for up to two doses of the study’s standard chemotherapy (mFOLFIRINOX or NALIRIFOX) during the screening period, means you cannot join. If you had chemotherapy after surgery (neoadjuvant or adjuvant), the cancer must have come back at least 6 months after finishing that treatment.
  • If you have previously been treated with a drug that specifically targets the KRAS G12D mutation, you are not allowed to participate.
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Investigated drugs

ASP3082
ASP3082 is an experimental medicine being tested for the first time in people with pancreatic cancer that has a specific KRAS G12D mutation. It contains the active substance setidegrasib, which is designed to block signals that help the cancer cells grow and survive. In the study, ASP3082 is given through an IV infusion and is combined with standard chemotherapy to see if it can improve survival compared with chemotherapy alone. mFOLFIRINOX
mFOLFIRINOX is a modified chemotherapy regimen that mixes several cancer‑killing drugs into one treatment plan. It includes medicines that stop cancer cells from making DNA and from dividing, such as fluorouracil, leucovorin, irinotecan, and oxaliplatin. This combination is given by IV and is a common first‑line therapy for advanced pancreatic cancer. In the trial, it is used together with either ASP3082 or a placebo to test whether adding the new drug helps patients live longer. NALIRIFOX
NALIRIFOX is another chemotherapy combination used for pancreatic cancer. It contains many of the same drugs as mFOLFIRINOX but replaces one of them with a special form of irinotecan that is packaged in tiny particles (nanoliposomal irinotecan). This formulation is meant to stay in the body longer and target the tumor more effectively. Like mFOLFIRINOX, it is given by IV infusion and serves as the standard treatment backbone in the study, allowing researchers to see if adding ASP3082 provides extra benefit.

What is already known about the treatment

  • Dextrose 5% in water solution for infusion

    This medication is given by slow intravenous (IV) infusion, where the liquid is poured directly into a vein. It is a sterile sugar (glucose) solution that is already approved and widely used in hospitals as a harmless fluid to keep patients hydrated and to provide a small amount of energy. It does not treat any disease and is used only as a control (placebo) in this trial. It belongs to the class of isotonic carbohydrate solutions.

  • ASP3082

    ASP3082 is supplied as a concentrate that is mixed with a liquid and given by intravenous infusion into a vein. It is still an investigational drug being studied in Phase 3 clinical trials for adults with metastatic pancreatic cancer that has a KRAS G12D mutation. The active ingredient, setidegrasib, works by blocking the abnormal KRAS protein, which stops signals that make cancer cells grow and survive. It is classified as a targeted therapy, specifically a KRAS inhibitor.

Investigated diseases

Metastatic pancreatic ductal adenocarcinoma - A cancer that begins in the ducts of the pancreas and later spreads to distant parts of the body. Cancer cells multiply rapidly, forming new tumor deposits in organs such as the liver or lungs. As the disease progresses, the size and number of these tumors increase, leading to a gradual worsening of the condition.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523684-38-00Protocol code3082-CL-0301Estimated enrolment614 patientsSponsorAstellas Pharma Global Development Inc.

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