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Monoclonal Antibodies

M6223 for Metastatic Tumor

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 time from baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 2 years)
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1A and 1B: Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period (28 Days)
Part IA and IB: Occurrence of Change From Baseline in Eastern Cooperative Oncology Group Performance Status
Part IA and IB: Occurrence of Clinically Significant Change From Baseline in Clinical Laboratory Measures
+4 more
Secondary outcome measures
Part 1A and 1B: Change from Baseline in QT Interval
Part 1A and 1B: Disease Control According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as per Investigator
Part 1A and 1B: Duration of Response According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as per Investigator
+16 more

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

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,802 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,598 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,917 Total Patients Enrolled

Media Library

Bintrafusp alfa (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04457778 — Phase 1
Metastatic Tumor Research Study Groups: Part 1A: M6223 Monotherapy, Part1B: M6223 + Bintrafusp alfa
Metastatic Tumor Clinical Trial 2023: Bintrafusp alfa Highlights & Side Effects. Trial Name: NCT04457778 — Phase 1
Bintrafusp alfa (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04457778 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently involved in this research?

"Affirmative. As per clinicaltrials.gov, this medical endeavour is presently seeking volunteers; the posting was initially made on July 10th 2020 with a most recent update dated November 4th 2022. Fifty-five candidates are being admitted at four different sites for participation in the trial."

Answered by AI

Could you enumerate the prior research studies concerning M6223?

"M6223 has been tested in clinical trials since 2016 at GSK Investigational Site. There are currently 4 completed studies and 22 active ones, with many of them located around San Antonio and Tennessee."

Answered by AI

Are any North American health centers currently conducting this clinical experiment?

"Currently, this medical trial is recruiting from 4 different sites with locations in San Antonio, Nashville and Houston. It is recommended to choose the closest clinic when enrolling to reduce travel-related requirements."

Answered by AI

Are participants being actively sought for this clinical trial?

"Affirmative. Clinicaltrials.gov showcases that this medical trial, since it was initially posted on July 10th 2020, is still seeking participants. As of now, the study seeks to include 55 patients across 4 different sites."

Answered by AI

Is this the inaugural clinical trial of its kind?

"In 2016, Merck Sharp & Dohme LLC sponsored the first clinical trial for M6223. This 829-patient study led to a Phase 1 drug approval and has since then sparked an impressive 22 active trials located in 21 countries across 59 cities."

Answered by AI

To what extent could M6223 pose a hazard to individuals?

"Our team at Power has assessed M6223's safety as a score of 1, since it is only in the preliminary stages of being tested. Therefore, there are limited data points to support its efficacy and security."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
First in Human Study of M6223
2020. "First in Human Study of M6223". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04457778.
~12 spots leftby Apr 2025
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