Clinical trial · Interventional
Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [14C]Berzosertib | Drug | Berzosertib | ALIAS |
| Berzosertib | Drug | Berzosertib | ALIAS |
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- [14C]Berzosertib
- 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.
- interventionNames
- Drug: [14C]Berzosertib
- type
- EXPERIMENTAL
- label
- Berzosertib + Topotecan
- 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.
- interventionNames
- Drug: Berzosertib
- Drug: Topotecan
Primary outcomes (21)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBolleddula J, Scheible H, Huber F, Seithel-Keuth A, Schieferstein H, Vagge DS, Mammasse N, Jaks E, Ferrer J, Moulin C, Dong J, Venkatakrishnan K, Papai Z. Microtracer-Based Assessment of the Mass Balance, Pharmacokinetics, and Excretion of [14C]Berzosertib, an Intravenous ATR Inhibitor, in Patients With Advanced Solid Tumors: A Phase 1 Study. Clin Pharmacol Drug Dev. 2025 Sep;14(9):700-709. doi: 10.1002/cpdd.1554. Epub 2025 May 28. PMID 40437704