M3541 in Combination With Radiotherapy in Solid Tumors

Phase 1 Terminated 15 enrolled EMD Serono Research & Development Institute, Inc. Merck KGaA, Darmstadt, Germany · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

This dose-escalation study evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and explore antitumor activity of M3541 in combination with fractionated palliative radiotherapy (RT) in participants with solid tumors with malignant lesions in the thorax, abdominal cavity, head and neck region, or extremities likely to benefit from palliative RT.

Timeline

Start: 2017-09-06
Primary completion: 2019-09-02
Completion: 2020-04-27

Outcome

Outcome not reported

Stopped (Business): “The study was terminated early per sponsor decision to halt further development of M3541 due to pharmaceutical and PK/pharmacodynamics properties that precluded further clinical development.”

Publications

Waqar SN, Robinson C, Olszanski AJ, Spira A, Hackmaster M, Lucas L, Sponton L, Jin H, Hering U, Cronier D, Grinberg M, Seithel-Keuth A, Diaz-Padilla I, Berlin J. Phase I trial of ATM inhibitor M3541 in combination with palliative radiotherapy in patients with solid tumors. Invest New Drugs. 2022 Jun;40(3):596-605. doi: 10.1007/s10637-022-01216-8. Epub 2022 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	M3541	Unknown	50 mg	Oral
Subject	M3541	Unknown	100 mg	Oral
Subject	M3541	Unknown	200 mg	Oral
Subject	M3541	Unknown	300 mg	Oral