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A Study of Lorigerlimab in Participants With Advanced Solid Tumors
Sponsor: MacroGenics
Summary
Study CP-MGD019-03 is an open-label study of lorigerlimab in participants with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). Approximately 60 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC. Participants will receive lorigerlimab by intravenous (IV) infusion on Day 1 of every 21-day treatment cycle. Treatment cycles will continue until progression of cancer, unacceptable side effects, withdrawal of consent by the participant, or the study ends. Participants will be monitored closely for side effects by physical exam and routine laboratory tests every cycle. Tumor status will be checked approximately every 9 weeks for the first year, then every 12 weeks for the duration of treatment. Participants will have a safety followup performed within 30 days after treatment discontinuation. Participants who discontinue study treatment for reasons other than progression of cancer, will continue CA-125 and tumor assessments every 12 weeks. Participants who discontinue study treatment for progression of cancer will enter the 6-month survival follow up portion of the study.
Official title: A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-05-01
Completion Date
2027-08
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Lorigerlimab
Bispecific DART protein binding PD-1 and CTLA-4
Locations (16)
UCLA
Los Angeles, California, United States
Ochsner MD Anderson Cancer Center
New Orleans, Louisiana, United States
START Midwest
Grand Rapids, Michigan, United States
West Penn Allegheny Health
Pittsburgh, Pennsylvania, United States
Mays Clinic
Houston, Texas, United States
START San Antonio
San Antonio, Texas, United States
Wisconsin Institute Medical Research- UW Cancer Connect
Madison, Wisconsin, United States
Princess Margaret Cancer Center
Toronto, Ontario, Canada
McGill University
Montreal, Quebec, Canada
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Hospital Bundang Hospital
Seongnam-si, Gyeonnggi-Do, South Korea
Yonsei University Health System Severance Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea