Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Phase 1 Completed 6 enrolled Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The study was conducted in two periods, Period 1 (mass balance) and Period 2 (extension). The purpose of Period 1 of this study was to provide a quantitative characterization of the mass balance, rates and routes of elimination, and metabolic pathways after a single intravenous administration of \[14C\]berzosertib. The purpose of Period 2 was to assess safety and efficacy of berzosertib in combination with topotecan.

Timeline

Start: 2022-02-15
Primary completion: 2023-06-28
Completion: 2023-06-28

Publications

Bolleddula J, Scheible H, Huber F, Seithel-Keuth A, Schieferstein H, Vagge DS, Mammasse N, Jaks E, Ferrer J, Moulin C, Dong J, Venkatakrishnan K, Papai Z. Microtracer-Based Assessment of the Mass Balance, Pharmacokinetics, and Excretion of [14C]Berzosertib, an Intravenous ATR Inhibitor, in Patients With Advanced Solid Tumors: A Phase 1 Study. Clin Pharmacol Drug Dev. 2025 Sep;14(9):700-709. doi: 10.1002/cpdd.1554. Epub 2025 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Berzosertib	Small molecule	210 mg/m2	Intravenous
Subject	Topotecan	Small molecule	1.25 mg/m2	Intravenous

Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Summary

Timeline

Publications

Drugs

Indications