Your session is about to expire
← Back to Search
Monoclonal Antibodies
M9466 + Tuvusertib for Cancer
Phase 1
Recruiting
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator
Eastern Cooperative Oncology Group Performance Status <= 1
Must not have
Cerebrovascular accident or stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety, effectiveness, and how the body processes a drug called M9466 when used alone or with another drug called tuvusertib in people with advanced solid tumors.
Who is the study for?
This trial is for individuals with advanced solid tumors. Participants will receive treatment until their disease progresses, they pass away, decide to leave the study, or when the study ends. They'll visit the clinic weekly at first and then every three weeks.
What is being tested?
The trial is testing M9466 alone or combined with Tuvusertib on patients with advanced solid tumors. It aims to assess safety, how well it's tolerated, how it affects and moves within the body (pharmacokinetics/pharmacodynamics), and its initial effectiveness.
What are the potential side effects?
Possible side effects of M9466 and Tuvusertib may include typical reactions seen in cancer treatments such as nausea, fatigue, allergic responses but specific side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced and hasn't responded to standard treatments.
Select...
I can carry out all my self-care but cannot do heavy physical work.
Select...
I haven't had certain cancer treatments for a specific time before starting the study drug.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: M9466 with AA-P(abiraterone acetate and prednisone or prednisolone)Experimental Treatment2 Interventions
Group II: M9466 plus TuvusertibExperimental Treatment2 Interventions
Group III: M9466 MonotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone acetate
2014
Completed Phase 3
~3440
Prednisone/Prednisolone
2017
Completed Phase 3
~2510
Find a Location
Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
85 Previous Clinical Trials
22,637 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
446 Previous Clinical Trials
114,806 Total Patients Enrolled
Medical ResponsibleStudy DirectorEMD Serono Research & Development Institute, Inc.
300 Previous Clinical Trials
61,083 Total Patients Enrolled