First in Human Study of M6223

PHASE1CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

July 10, 2020

Primary Completion Date

June 23, 2023

Study Completion Date

June 23, 2023

Conditions
Metastatic Solid Tumors
Interventions
DRUG

M6223

Participants will receive an intravenous (IV) infusion of M6223 at escalated doses every 2 weeks (Q2W) or every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.

DRUG

Bintrafusp alfa

Participants will receive an IV infusion of bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) until confirmed disease progression.

DRUG

M6223

Participants will receive an IV infusion of M6223 at escalated doses Q2W on Day 1 of each Cycle (Each cycle is of 21 days) according to the recommendation of the SMC until the MTD has been reached or confirmed disease progression.

Trial Locations (4)

37203

Sarah Cannon Research Institute, Nashville

77030

MD Anderson Cancer Center, Houston

78229

Next Oncology, San Antonio

Unknown

Princess Margaret Cancer Centre, Toronto

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT04457778 - First in Human Study of M6223 | Biotech Hunter | Biotech Hunter