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
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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Healthy Volunteers:
No

• 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
Hungary
Magyar Honvédség Egészségügyi Központ, Podmaniczky utcai telephely, Onkológiai Osztály
Recruiting
Budapest
PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely
Recruiting
Budapest
Who do I contact about this trial?
Primary
Communication Center
service@emdgroup.com
+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

This content was sourced from clinicaltrials.gov