M9466
DrugParticipants will be administered M9466 orally.
Other names: HRS-1167;
NCT Number: NCT06421935
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Cancer Research SA, Adelaide, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be administered M9466 orally.
Other names: HRS-1167;
Participants will be administered Tuvusertib orally.
Other names: Substance code MSC2584415A; also known as M1774, VXc-400, or VR 1363004
Participants will be administered with Abiraterone acetate orally.
Other names: Abiraterone
Participants will be administered with prednisone/prednisolone orally.
Time frame: Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
Time frame: Day 1 up to Day 21 of Cycle 1 (each cycle is of 21 days)
Time frame: Cycle 1 Day 1 (C1D1), C1D8 and C1D15
Time frame: Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
Time frame: Time from first treatment up to 30 days after end of study intervention
Time frame: Day 1 up to Day 21 of Cycle 1(each cycle is of 21 days)
Time frame: Module 1 Part A1: C1D1 and C1D5 or C1D6; Module 1 Part A2: C1D1, C1D2, C1D3 or C1D4 and C1D8; Module 2 Part A1: C1D1, C1D8 and C1D15; Module 2 Part A2: C1D1, C1D2 and C1D8, C1D22 and C2D1; Module 2 Part A1: C1D1 and C1D8
Time frame: Time from first treatment to planned assessment at 12 months
Time frame: Time from first treatment to planned assessment at 12 months
Time frame: Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
Time frame: Day 1, Day 8 and Day 15
EMD Serono Research & Development Institute, Inc.
Industry
An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid Tumors
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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