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Brief Title: M9466 as Single Agent or in Combination With Tuvusertib in Advanced Solid Tumors (DDRiver 501)
Official Title: An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 as a Single Agent and in Combination With the ATR Inhibitor Tuvusertib in Participants With Advanced Solid Tumors (DDRiver 501)
Study ID: NCT06421935
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 as monotherapy or in combination 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Please Contact U.S. Medical Information, Rockland, Massachusetts, United States
Please Contact the Communication Center, Darmstadt, , Germany
Name: Medical Responsible
Affiliation: EMD Serono Research & Development Institute, Inc.
Role: STUDY_DIRECTOR