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

Conditions

• Locally Advanced Pancreatic Adenocarcinoma
• Stage III Pancreatic Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo tissue collection
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT
• Hypofractionated Radiation Therapy — RADIATION
  Undergo hypofractionated radiation therapy
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Peposertib — DRUG
  Given PO
• Placebo Administration — OTHER
  Given PO

Study Details

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.

Key Dates

Start date

Jan 11, 2021

Status verified

Jan 2026

Primary completion

Aug 1, 2026

Completion

Aug 1, 2026

Study Design

Enrollment

92 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase I (hypofractionated radiation therapy, M3814)
  Patients in Phase I undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive M3814 PO QD for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.
• Experimental: Phase II Group I (hypofractionated radiation therapy M3814)
  Patients in Phase II undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive M3814 PO QD for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.
• Placebo Comparator: Phase II Group II(hypofractionated radiation therapy, placebo)
  Patients in Phase II undergo hypofractionated radiation therapy for 5 fractions QOD over 2 weeks and receive placebo PO QD for 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and tissue biopsy on study. Patients also undergo CT and MRI during screening and on study.

Primary Outcome Measure

Maximum tolerated dose (Phase I) [ Time Frame: Up to 14 days ]

Locations (44)

Find similar trials in Duarte, CA

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