Phase 12 Study of M3814 Peposertib with Hypofractionated Radiotherapy for Locally Advanced Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the safety, side effects, and best dose of a drug called M3814 peposertib when combined with hypofractionated radiation therapy in treating patients with locally advanced pancreatic cancer that has spread to nearby tissue or lymph nodes. This phase III trial aims to see if this combination is safe, tolerable, and possibly more effective than radiation therapy alone. M3814 works by blocking enzymes needed for tumor cell growth, while hypofractionated radiation delivers higher doses over a shorter time to kill more tumor cells with fewer side effects. The study includes two phases Phase I involves dose escalation where patients receive hypofractionated radiation therapy for 5 fractions every other day over 2 weeks along with daily oral M3814 for 14 days. Phase II randomly assigns patients to either receive the same combination of radiation and M3814 or radiation with a placebo, both given under the same schedule. Blood samples, tissue biopsies, CT scans, and MRI scans are collected during screening and treatment. Participants undergo follow-up visits at 30, 60, and 90 days after completing treatment, then every 3 months for up to 2 years. Researchers monitor progression-free survival, overall survival, tumor response by imaging, and disease control. They also study pharmacokinetics of M3814 and explore gene patterns in tumor tissue and blood to understand treatment effects. The total participation may last up to 2 years including treatment and monitoring.

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