Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05246111
Collaborator
(none)
6
2
1
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Feb 15, 2022
Anticipated Primary Completion Date :
Mar 20, 2023
Anticipated Study Completion Date :
Mar 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: M6620, [14C]M6620 and Topotecan

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.

Drug: 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.
Other Names:
  • MSC2527093A, M6620, VX-970
  • Drug: 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.

    Outcome Measures

    Primary Outcome Measures

    1. Period 1: Percent Urinary Recovery (feurine) of Total Radioactivity [Pre-dose until discharge criteria are met, assessed up to 14 days post-dose]

    2. Period 1: Percent Fecal Recovery (fefeces) of Total Radioactivity [Pre-dose until discharge criteria are met, assessed up to 14 days post-dose]

    3. 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]

    4. Period 1: Pharmacokinetic (PK) Plasma and Urine Concentration of M6620 [Pre-dose until discharge criteria are met, assessed up to 14 days post-dose]

    5. 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 Outcome Measures

    1. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Magyar Honvédség Egészségügyi Központ, Podmaniczky utcai telephely, Onkológiai Osztály Budapest Hungary 1062
    2 PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely Budapest Hungary 1077

    Sponsors and Collaborators

    • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    Investigators

    • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    ClinicalTrials.gov Identifier:
    NCT05246111
    Other Study ID Numbers:
    • MS201923_0008
    • 2021-002226-24
    First Posted:
    Feb 18, 2022
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 23, 2022