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Active Not Recruiting
NCT06421935
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)
Conditions: Advanced Solid Tumor
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 60
Sponsor: EMD Serono Research & Development Institute, Inc.
Location: NEXT Oncology - PARENT New York New York
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Module 1 Part A and Module 2 Part A1: Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator
* Module 1 Part A2: Histologically or pathologically confirmed advanced or metastatic CRPC or EOC
* Eastern Cooperative Oncology Group Performance Status less than or equal to (\
Source: ClinicalTrials.gov (NCT06421935). StuddyBuddy aggregates publicly available trial information.