Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: Berzosertib; Drug: [14C]Berzosertib; Drug: Topotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT05246111

MS201923_0008

2021-002226-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

[14C]Berzosertib

Experimental group

Description:

Participants received single intravenous infusion of\[14C\]Berzosertib at a dose of 210 milligrams per square meter (mg/m\^2) 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.

Treatment:

Drug: [14C]Berzosertib

Berzosertib + Topotecan

Experimental group

Description:

Participants received single intravenous infusion of Berzosertib at a dose of 210 mg/m\^2 on Day 2 and Day 5 in combination with topotecan at a dose of 1.25 mg/m\^2 intravenously on Days 1 through 5 of each 21-day cycle in period 2 until disease progression or other criteria for study intervention discontinuation were met.

Treatment:

Drug: Topotecan

Drug: Berzosertib