Phase I Study to Evaluate the Mass Balance, PK, Metabolism and Excretion of Berzosertib (Intravenous) Containing Microtracer [14C]Berzosertib in Participants With Advanced Solid Tumors (DDRiver Solid Tumors 208)

Trial Information
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1

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.

Am I eligible for this trial?
Participation Requirements
Minimum Age:
Healthy Volunteers:

• 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

Where is this trial taking place?
Other Locations
Magyar Honvédség Egészségügyi Központ, Podmaniczky utcai telephely, Onkológiai Osztály
PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Who do I contact about this trial?
Communication Center
+49 6151 72 5200
When is this trial taking place?
Start Date: February 15, 2022
Estimated Completion Date: March 20, 2023
How many participants will be in this trial?
Target number of participants: 6
What treatment is being studied in this trial?
Experimental: M6620, [14C]M6620 and Topotecan

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