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OncoMatch/Clinical Trials/NCT04172532

Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

Is NCT04172532 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Peposertib for locally advanced pancreatic adenocarcinoma.

Phase 1/2RecruitingNational Cancer Institute (NCI)NCT04172532Data as of May 2026

Treatment: PeposertibThis 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.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Disease stage

Required: Stage III, STAGE III (AJCC v8, NCCN Guidelines v1.2020)

Excluded: Stage DISTANT METASTATIC DISEASE

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: ... [see above for full vessel involvement criteria]

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: chemotherapy (FOLFIRINOX, NALIRIFOX, gemcitabine/Abraxane) — induction

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

Cannot have received: chemotherapy

Exception: unless the change in treatment was made only for toxicity

More than 1 line of chemotherapy for the treatment of localized pancreatic cancer, unless the change in treatment was made only for toxicity

Cannot have received: radiation therapy (abdominal radiation)

Prior abdominal radiation

Lab requirements

Blood counts

Leukocytes >= 4,000/mcL; Absolute neutrophil count >= 1.5 x 10^9/L; Hemoglobin >= 9 g/dL; Platelets >= 100 x 10^9/L

Kidney function

Creatinine <= 1.5 x institutional ULN; Glomerular filtration rate (GFR) >= 51 mL/min/1.73 m^2

Liver function

Total bilirubin <= 2.0 x institutional upper limit of normal (ULN); AST/ALT <= 3 x institutional ULN

Cardiac function

American Heart Association Stage B or better and New York Heart Association Functional Classification II or better

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 ULN; AST/ALT <= 3 x institutional ULN; Creatinine <= 1.5 x institutional ULN; GFR >= 51 mL/min/1.73 m^2; cardiac: AHA Stage B or better, NYHA II or better

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Comprehensive Cancer Center · Duarte, California
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
  • City of Hope at Irvine Lennar · Irvine, California
  • UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
  • University of California Davis Comprehensive Cancer Center · Sacramento, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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