Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

• Status: Not yet recruiting
• Trial end date: 2023-03-20
• Target enrollment: 0
• Participant gender: All

Summary

The study will be conducted in two periods, Period 1 (mass balance) and Period 2 (extension). The purpose of Period 1 of this study is 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 is to assess safety and efficacy of berzosertib in combination with topotecan.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Treatments: Topotecan

Criteria

Inclusion Criteria: .

• Histologically proven advanced solid tumors that are considered appropriate for treatment in Period 2 of this study, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) =< 1

• Evaluable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Screening

• Participant has adequate renal, hematological and hepatic function

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Participants with uncontrolled intercurrent illness including, but not limited to, severe active infection including, acute respiratory syndrome coronavirus-2 infection/coronavirus disease 2019 (Covid 19), immune deficiencies, uncontrolled diabetes, uncontrolled arterial hypertension and symptomatic congestive heart failure

• Concurrent participation in another interventional clinical study is not permitted.

• Known hypersensitivity to the study interventions, a similar structural compound, or to one or more excipients used

• Prior or concurrent treatment with a nonpermitted drug/intervention from the first dose of study intervention administration, as defined per protocol.

• Other protocol defined exclusion criteria could apply