Spots Global Cancer Trial Database for First in Human Study of M6223
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Trial Identification
Brief Title: First in Human Study of M6223
Official Title: Phase I, First-in-Human, Open-Label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of M6223, an Inhibitor of TIGIT, as Single Agent and in Combination With Bintrafusp Alfa (Anti-PDL1/ TGFß Trap) in Participants With Metastatic or Locally Advanced Solid Unresectable Tumors
Study ID: NCT04457778
Conditions
Study Description
Brief Summary: The main purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), immunogenicity and (if observed) the maximum tolerated dose (MTD) of M6223 as a single agent (Part 1A) for both the every 2 weeks (Q2W) regimen and the every 3 weeks (Q3W) regimen and of M6223 combined with bintrafusp alfa (Part 1B) for Q2W regimen in participants with metastatic or locally advanced solid unresectable tumors.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sarah Cannon Research Institute, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Next Oncology, San Antonio, Texas, United States
Princess Margaret Cancer Centre, Toronto, , Canada
Contact Details
Name: Medical Responsible
Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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