Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)
NCT06433219 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63
Last updated 2026-02-18
Summary
The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between tuvusertib monotherapy and combination therapy. The participants will previously have progressed while treated with a poly ADP ribose polymerase (PARP) inhibitor. The primary objectives of this study are to assess the effect of the treatment in terms of overall response, i.e. whether the tumor disappears, shrinks, remains unchanged, or gets worse and safety in terms of adverse events.
Conditions
Interventions
- DRUG
-
Tuvusertib (M1774)
Tuvusertib will be administered orally.
- DRUG
-
Niraparib
Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
- DRUG
-
Lartesertib (M4076)
Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib
Sponsors & Collaborators
-
Merck KGaA, Darmstadt, Germany
collaborator INDUSTRY -
EMD Serono Research & Development Institute, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Responsible · EMD Serono Research & Development Institute, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-30
- Primary Completion
- 2025-09-29
- Completion
- 2026-06-26
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Denmark
- France
- Germany
- Israel
- Italy
- Netherlands
- Poland
- Spain
- Switzerland
- United Kingdom
Study Locations
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