Actively Recruiting
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
92
Participants Needed
44
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I/II trial studies the safety, side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving M3814 and hypofractionated radiation therapy together may be safe, tolerable and/or more effective than radiation therapy alone in treating patients with locally advanced pancreatic cancer.
CONDITIONS
Official Title
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have confirmed pancreatic adenocarcinoma, excluding other types.
- Completed 4-6 months of induction chemotherapy with standard regimens like FOLFIRINOX or gemcitabine/Abraxane.
- Locally advanced pancreatic cancer as defined by specific tumor involvement on CT scan within 21 days of registration.
- Confirmation of locally advanced disease and non-surgical treatment plan by local multi-disciplinary review.
- Measurable disease according to RECIST v1.1 criteria.
- Age 18 years or older.
- ECOG performance status 0, 1, or 2 (Karnofsky score 60% or higher).
- Leukocytes ≥ 4,000/mcL.
- Absolute neutrophil count ≥ 1.5 x 10^9/L.
- Hemoglobin ≥ 9 g/dL.
- Platelets ≥ 100 x 10^9/L.
- Total bilirubin ≤ 2.0 times institutional upper limit of normal.
- AST/ALT ≤ 3 times institutional upper limit of normal.
- Creatinine ≤ 1.5 times institutional upper limit of normal.
- Glomerular filtration rate ≥ 51 mL/min/1.73 m².
- HIV patients on effective therapy with undetectable viral load within 6 months.
- Patients with chronic hepatitis B must have undetectable viral load if on therapy.
- Patients with hepatitis C must be cured or have undetectable viral load if on treatment.
- Female patients of childbearing potential must have a negative pregnancy test within 72 hours before treatment and agree to use contraception during and for 12 weeks after treatment.
- Male patients must agree to use adequate contraception during and for 12 weeks after treatment.
- Patients with history or symptoms of cardiac disease must have acceptable heart function according to defined clinical stages.
- Ability to understand and willing to sign informed consent; patients with impaired decision capacity may participate with a legal representative.
You will not qualify if you...
- Completed induction chemotherapy less than 2 weeks or more than 8 weeks before enrollment.
- Not recovered from previous anti-cancer therapy side effects above grade 1, except alopecia and mild neuropathy.
- Receiving other investigational drugs.
- Allergic reactions to compounds similar to M3814.
- Evidence of distant metastases.
- More than one chemotherapy line for localized pancreatic cancer unless changed due to toxicity.
- Prior abdominal radiation therapy.
- Active inflammatory bowel or connective tissue disease.
- Inability to swallow oral medications or gastrointestinal conditions affecting absorption.
- History of severe allergic reaction to iodinated IV contrast; mild reactions allowed with premedication.
- Unable to discontinue medications or supplements that strongly affect certain liver enzymes related to drug metabolism.
- Unable to stop proton-pump inhibitors at least 5 days before treatment; H2 blockers and antacids allowed.
- Received live attenuated vaccine within 30 days before M3814 dosing.
- Uncontrolled illnesses or psychiatric/social conditions limiting study compliance.
- Pregnant or breastfeeding women.
- Prior or concurrent cancers that could interfere with safety or effectiveness assessments.
AI-Screening
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Trial Site Locations
Total: 44 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
3
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
4
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
5
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
6
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
8
Northwestern University
Chicago, Illinois, United States, 60611
Active, Not Recruiting
9
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
10
HaysMed
Hays, Kansas, United States, 67601
Actively Recruiting
11
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
12
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Actively Recruiting
13
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States, 66061
Actively Recruiting
14
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
15
Mercy Hospital Pittsburg
Pittsburg, Kansas, United States, 66762
Suspended
16
Salina Regional Health Center
Salina, Kansas, United States, 67401
Actively Recruiting
17
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States, 66606
Actively Recruiting
18
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
19
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Withdrawn
20
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Active, Not Recruiting
21
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Active, Not Recruiting
22
University Health Truman Medical Center
Kansas City, Missouri, United States, 64108
Actively Recruiting
23
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
24
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
25
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States, 64116
Suspended
26
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Active, Not Recruiting
27
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
28
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
29
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
30
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Active, Not Recruiting
31
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Active, Not Recruiting
32
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
33
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
34
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Active, Not Recruiting
35
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Active, Not Recruiting
36
Wake Forest University at Clemmons
Clemmons, North Carolina, United States, 27012
Active, Not Recruiting
37
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro, North Carolina, United States, 28659
Active, Not Recruiting
38
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Active, Not Recruiting
39
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
40
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
41
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
42
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
43
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
44
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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