NCT06433219

Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

An Open-label, Multicenter, Randomized Phase 2 Study of the ATR Inhibitor Tuvusertib in Combination With the PARP Inhibitor Niraparib or the ATM Inhibitor Lartesertib in Participants With BRCA Mutant and/or Homologous Recombination deficiency (HRD)-Positive Epithelial Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy (DDRiver EOC 302)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Ovarian Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-30
• Primary completion: 2025-09-29
• Completion: 2026-06-26
• First posted: 2024-05-29
• Last updated: 2026-02-18

Locations

84 sites across 13 countries: United States, Australia, Belgium, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study