A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
Start Date
2/26/2025
Completion Date
2/1/2029
Summary
IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.
Detailed Description
IM-1021-101 is a 2-part Phase 1 first-in-human (FIH), open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of the ROR1 directed antibody-drug conjugate (ADC) IM-1021. IM-1021 will be administered to participants with advanced B-cell lymphomas and advanced solid tumors. Part A of the study is a dose escalation phase to evaluate safety and tolerability of IM-1021 and to determine recommended doses for further development. IM-1021 will be administered intravenously on an intermittent basis. The safety and tolerability of escalating doses of IM-1021 will be evaluated. Alternative dosing schedules may also be evaluated. Part B of the study is an expansion phase to further evaluate safety and tolerability of IM-1021 at candidate recommended doses in indication specific cohorts of participants. The safety and preliminary efficacy endpoints of this study will inform a preliminary risk-benefit assessment of IM-1021 in this patient population.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
IM-1021
Conditions
Locations
City Of Hope
Duarte, California 91010
United States
University of California
Los Angeles, California 90095
United States
Colorado Blood Cancer Institute
Denver, Colorado 80218
United States
Yale University Medical Center
New Haven, Connecticut 06510
United States
Emory Winship Cancer Institute
Atlanta, Georgia 30322
United States
University of Iowa
Iowa City, Iowa 52242
United States
Norton Cancer Institute
Louisville, Kentucky 40202
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
START Midwest
Grand Rapids, Michigan 49546
United States
University of Nebraska Medical Center
Omaha, Nebraska 68105
United States
Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Gabrail Cancer Center
Canton, Ohio 44718
United States
Brown University
Providence, Rhode Island 02903
United States
Sarah Cannon Research Institute - Oncology Partners
Nashville, Tennessee 37203
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Oncology
Irving, Texas 75039
United States
UT San Antonio Mays Cancer
San Antonio, Texas 78229
United States
Copenhagen University Hospital
Copenhagen, DK-2100
Denmark
Centre Leon-Berard
Lyon, 69008
France
LITO, Institut Curie Hospital Gropu
Paris, 75005
France
Gustave Roussy
Villejuif, 94805
France
START - Fundacion Jimenez Diaz
Madrid, 28040
Spain