Tuvusertib (M1774)
DrugTuvusertib will be administered orally.
Other names: M1774, VXc-400, VRT-1363004, substance code MSC2584415A
NCT Number: NCT06433219
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Female
Interventional
Phase 2
Chris O'Brien Lifehouse, Camperdown, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
OR Progression on second-line maintenance PARPi: Participants are not allowed any additional systemic anticancer treatments before study entry (that is PARPi is the last treatment before study entry)
Exclusion criteria
Tuvusertib will be administered orally.
Other names: M1774, VXc-400, VRT-1363004, substance code MSC2584415A
Niraparib will be administered orally. If selected from Part A, Niraparib will be administered orally in combination with Tuvusertib.
Other names: GSK3985771, MK-4827
Lartesertib will be administered orally. If selected from Part A, Lartesertib will be administered orally in combination with Tuvusertib
Other names: M4076, substance code MSC2585823A
Time frame: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Time frame: Time from randomization to final assessment at end of safety follow-up visit, approximately up to 3.5 years
Time frame: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Time frame: Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years
Time frame: Time from date of randomization to death, approximately 3.5 years
OS is defined as the time from randomization to death due to any cause.
EMD Serono Research & Development Institute, Inc.
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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