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Monoclonal Antibodies
First in Human Study of M6223
Nashville, TN
Phase 1
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer drug to see if it is safe and effective.
See full description
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
2Treatment groups
Experimental Treatment
Group I: Part1B: M6223 + Bintrafusp alfaExperimental Treatment2 Interventions
Group II: Part 1A: M6223 MonotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bintrafusp alfa
Not yet FDA approved
M6223
2020
Completed Phase 1
~60
Find a Location
Closest Location:Sarah Cannon Research Institute· Nashville, TN
Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
85 Previous Clinical Trials
22,676 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
448 Previous Clinical Trials
122,242 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
301 Previous Clinical Trials
61,212 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received an organ transplant or stem cell transplant in the past.You have been diagnosed with advanced cancer that has not responded to or has worsened with standard treatments, and there are no other known treatments that can help you.There may be additional criteria set by the study that you need to meet in order to participate.There may be additional reasons why you may not be eligible for this study, as determined by the study's specific rules.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1A: M6223 Monotherapy
- Group 2: Part1B: M6223 + Bintrafusp alfa
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.