Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Advanced Solid Tumor Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05246111
• Other study ID #: MS201923_0008
• Secondary ID: 2021-002226-24
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2022
• Est. completion date: June 28, 2023

Study information

• Verified date: July 2023
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• [14C]M6620
Participants will receive single intravenous infusion of [14C]M6620 on Day 1 in Period 1 and stay in clinical research unit (CRU) is required until the discharge criteria are met with a maximum confinement period of 15 days.
• M6620
Participants will receive intravenous infusion of M6620 on Day 2 and Day 5 of each 21-day cycle in period 2 until disease progression or other criteria for study intervention discontinuation are met.
• Topotecan
Participants will receive intravenous infusion of topotecan on Day 1 through Day 5 of each 21-day cycle in period 2 until disease progression or other criteria for study intervention discontinuation are met.

Locations

Country	Name	City	State
Hungary	Magyar Honvédség Egészségügyi Központ, Podmaniczky utcai telephely, Onkológiai Osztály	Budapest
Hungary	PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Period 1: Percent Urinary Recovery (feurine) of Total Radioactivity		Pre-dose until discharge criteria are met, assessed up to 14 days post-dose
Primary	Period 1: Percent Fecal Recovery (fefeces) of Total Radioactivity		Pre-dose until discharge criteria are met, assessed up to 14 days post-dose
Primary	Period 1: Percent Total Recovery in Urine and Feces (fetotal) of Total Radioactivity		Pre-dose until discharge criteria are met, assessed up to 14 days post-dose
Primary	Period 1: Pharmacokinetic (PK) Plasma and Urine Concentration of M6620		Pre-dose until discharge criteria are met, assessed up to 14 days post-dose
Primary	Period 1: Pharmacokinetic Plasma and Blood Concentration of Total Radioactivity		Pre-dose until discharge criteria are met, assessed up to 14 days post-dose
Secondary	Period 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events		Period 1: Baseline up to Day 14; Period 2: From Day 1 of period 2 until disease progression or other criteria for study intervention discontinuation are met (up to a maximum of approximately 14 months)

External Links

•   DDRiver website
•   Trial Awareness and Transparency website