Actively Recruiting
Study to Assess Setidegrasib With mFOLFIRINOX or NALIRIFOX Chemotherapy for KRAS G12D Mutated Metastatic Pancreatic Cancer
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-06-02
614
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Pancreatic cancer is often diagnosed late when it has spread to other parts of the body, making treatment challenging. This research aims to evaluate the drug setidegrasib combined with chemotherapy in adults who have metastatic pancreatic cancer with a specific KRAS G12D gene mutation. The study focuses on whether setidegrasib with chemotherapy helps people live longer compared to chemotherapy with a placebo, and also looks at safety and how the drug affects the body. Participants will be randomly assigned to receive either setidegrasib or a placebo once weekly, along with one of two chemotherapy regimens: mFOLFIRINOX or NALIRIFOX. Chemotherapy and study drugs are given through a vein via infusion in 28-day cycles. The chemotherapy choice is determined by the study doctor, with NALIRIFOX given only after its safety is confirmed in a related study. Treatment continues until the cancer worsens, side effects prevent continuation, or other treatment decisions are made. During the study, participants will have regular safety checks and medical assessments to monitor health and side effects. Researchers will measure overall survival for up to 3.5 years, progression-free survival, pain improvement, quality of life, tumor response, and various safety indicators. Pharmacokinetics of setidegrasib will be studied for up to 9 months. Monitoring continues throughout to ensure participant wellbeing and gather detailed information about treatment effects.
CONDITIONS
Brief Title
A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D mutation
- No option for surgery or radiotherapy aimed at cure
- Provide baseline tumor tissue specimen meeting study requirements
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days before randomization
- Adequate organ function based on recent lab tests
- Agree not to participate in another interventional study during this trial's treatment phase
You will not qualify if you...
- Diagnosis of neuroendocrine, acinar pancreatic carcinoma, or pancreatic cancer with squamous/adenosquamous features
- Active prior malignancy requiring treatment within past 2 years except certain local skin or bladder cancers
- Chronic inflammatory bowel disease, bowel obstruction, or severe uncontrolled diarrhea
- Peripheral sensory neuropathy with functional impairment
- Ascites or pleural effusion requiring invasive intervention within 30 days before randomization
- Symptomatic pulmonary embolism or untreated pulmonary embolism
- History of interstitial lung disease or pulmonary fibrosis
- Uncontrolled or refractory seizure disorder
- Known homozygous UGT1A1 polymorphism
- Recent serious cardiac events or uncontrolled heart conditions
- Prior systemic therapy for metastatic PDAC except limited chemotherapy during screening
- Prior treatment with KRAS G12D-targeted agents
- Corrected QT interval greater than 470 msec during screening ECG assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3.5 years
Participants receive setidegrasib or placebo once weekly along with mFOLFIRINOX or NALIRIFOX chemotherapy on a 28-day cycle.
Weekly visits for treatment and assessments on a 28-day cycle
Trial Site Locations
Total: 17 locations
1
Crosson Cancer Institute at Providence St. Jude Medical Center in Fullerton
Fullerton, California, United States, 92835
Actively Recruiting
2
Hoag Mem Hosp Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
3
Baptist MD Anderson Cancer Institute
Jacksonville, Florida, United States, 32207
Actively Recruiting
4
Saint Elizabeth Medical Center, Inc. DBA St. Elizabeth Health Care
Edgewood, Kentucky, United States, 41017
Actively Recruiting
5
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States, 55426
Actively Recruiting
6
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
7
NYU Long Island Mineola
Mineola, New York, United States, 11501
Actively Recruiting
8
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
9
White Plains Hospital Center for Cancer Care - Oncology
White Plains, New York, United States, 10601
Actively Recruiting
10
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
11
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Actively Recruiting
12
UVA Emily Couric Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
13
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
14
Virginia Mason Franciscan Health - Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
15
Kyushu Group - Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Actively Recruiting
16
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, Japan
Actively Recruiting
17
Yamaguchi University Hospital
Ube-shi, Yamaguchi, Japan
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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