M3814 (Peposertib) with Radiation for Locally Advanced Pancreatic Cancer
This study is testing a new anti-cancer drug, M3814 (Peposertib), combined with radiation therapy for patients with locally advanced pancreatic cancer. M3814 works by blocking certain enzymes that help cancer cells grow. The radiation therapy used in this study, called hypofractionated radiation therapy, delivers higher doses over a shorter time. Researchers want to find the safest and most effective dose of M3814 when given with this type of radiation. They will also see if this combination helps patients live longer without their cancer getting worse. You may be able to join if you have pancreatic adenocarcinoma that has spread to nearby tissues or lymph nodes and have already received 4-6 months of specific chemotherapy (FOLFIRINOX or similar). The study aims to enroll 92 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It is planned to enroll 92 participants.
- What's involved
- You would undergo a biopsy, blood sample collection, CT scans, and MRI scans. You would also receive hypofractionated radiation therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be assessed for up to 2 years after randomization.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04172532
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~92 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyHypofractionated Radiation TherapyMagnetic Resonance ImagingPeposertib
At a glance
Recruiting sites
28 of 44 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (Phase I)
Measured over Up to 14 days
+2 more outcomes measured
Conditions
NCT04172532
Where you'd take part
This study runs at 44 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
City of Hope at Irvine Lennar
Irvine, Californiastudy coordinator listed
Recruiting
City of Hope Comprehensive Cancer Center
Duarte, Californiastudy coordinator listed
Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jerseystudy coordinator listed
Recruiting
HaysMed
Hays, Kansasstudy coordinator listed
Recruiting
Lawrence Memorial Hospital
Lawrence, Kansasstudy coordinator listed
Recruiting
Monmouth Medical Center
Long Branch, New Jerseystudy coordinator listed
Recruiting
Mount Sinai Hospital
New York, New Yorkstudy coordinator listed
Recruiting
NYP/Weill Cornell Medical Center
New York, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sarah L Davis · PRINCIPAL_INVESTIGATOR · JHU Sidney Kimmel Comprehensive Cancer Center LAO
Who to contact
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Eligibility criteria
Inclusion
Patients must have pathologically confirmed pancreatic adenocarcinoma. Patients with alternative or mixed histologies (i.e., squamous, neuroendocrine, acinar, colloid) are not eligible
Received 4-6 months of induction chemotherapy with fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX), fluorouracil, liposomal irinotecan, leucovorin, oxaliplatin (NALIRIFOX), or gemcitabine/Abraxane, as per standard of care
Patients must have locally advanced pancreatic cancer according to National Comprehensive Cancer Network (NCCN) Guidelines (version 1.2020) on pancreas protocol CT scan performed within 21 days of registration. Locally advanced disease is defined as any of the following:
For head or uncinate process tumors:
Solid tumor contact with superior mesenteric artery \> 180 degrees
Solid tumor contact with the celiac axis \> 180 degrees
Solid tumor contact with the common or proper hepatic arteries \> 180 degrees or
For pancreatic body or tail tumors:
Solid tumor contact of \> 180 degrees with the superior mesenteric artery or celiac axis
Solid tumor contact with the celiac axis and aortic involvement or
Unreconstructible superior mesenteric vein or portal vein due to tumor involvement or occlusion (can be due to tumor or bland thrombus)
The determination of locally advanced pancreatic cancer and plan for non-operative treatment on this clinical trial must be confirmed through local multi-disciplinary review
Measurable disease per response evaluation criteria in solid tumors (RECIST) version (v)1.1
Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of M3814 (peposertib) in combination with hypofractionated radiation in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
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 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 x institutional ULN
Creatinine =\< 1.5 x institutional ULN
Glomerular filtration rate (GFR) \>= 51 mL/min/1.73 m\^2
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female patients of childbearing potential and male patients must be willing to use an adequate method of contraception for the course of the study through 12 weeks after the last dose of study medication.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function. To be eligible for this trial, patients should be American Heart Association Stage B (people without current or previous symptoms of heart failure but with either structural heart disease, increased filling pressures in the heart or other risk factors) or better and New York Heart Association Functional Classification II (slight limitation of physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain), or better
Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and/or family member available will also be eligible
Exclusion
Patients who have completed induction chemotherapy less than 2 weeks or more than 8 weeks prior to study enrollment
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia and neuropathy grade =\< 2
Patients who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to M3814 (peposertib)
Evidence of distant metastatic disease
More than 1 line of chemotherapy for the treatment of localized pancreatic cancer, unless the change in treatment was made only for toxicity
Prior abdominal radiation
Active inflammatory bowel disease or connective tissue disease
Inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents
History of anaphylactic reaction to iodinated intravenous (IV) contrast required for radiation simulation. Patients with mild reactions may be enrolled, but must receive premedications for contrast allergy prior to imaging
Patients who cannot discontinue concomitant medications or herbal supplements that are strong inhibitors or strong inducers of cytochrome P450 (CYP) isoenzymes CYP3A4/5, CYP2C9, and CYP2C19. Concomitant use of substrates with a narrow therapeutic index that are metabolized by CYP1A2, CYP2B6, CYP2C8, and CYP3A4/5 are also excluded.
Use caution with other substrates of CYP3A4/5, CYP1A2, CYP2B6, CYP2C8 and substrates of P-gp, BCRP, OCT1, OAT3, OATP1B1, OATP1B3, MATE1, and MATE-2K with a narrow therapeutic index. Close monitoring is advised.
Patients who cannot discontinue concomitant proton-pump inhibitors (PPIs). Patients may confer with the study doctor to determine if such medications can be discontinued. These must be discontinued \>= 5 days prior to study treatment. Patients do not need to discontinue calcium carbonate. H2 blockers and antacids are allowed.
Patients who have received a live attenuated vaccine within 30 days of dosing with M3814 (peposertib)
Patients with uncontrolled intercurrent illness
Patients with psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because M3814 (peposertib) is a DNA-protein kinase (PK) inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M3814 (peposertib), breastfeeding should be discontinued if the mother is treated with M3814 (peposertib)
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen
What this trial measures
- Maximum tolerated dose (Phase I)Up to 14 days
- Recommended phase 2 dose (Phase I)Up to 14 days
- Progression-free survival rate (Phase II)Time from randomization to progression or death whichever occurs first, assessed up to 2 years
The 95% confidence intervals will be provided.