A Study of Lorigerlimab in Participants With Advanced Solid Tumors
Start Date
5/1/2025
Completion Date
12/1/2027
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 80 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Lorigerlimab
Conditions
Locations
UCLA
Los Angeles, California 90095
United States
Ochsner MD Anderson Cancer Center
New Orleans, Louisiana 70115
United States
START Midwest
Grand Rapids, Michigan 49546
United States
West Penn Allegheny Health
Pittsburgh, Pennsylvania 15224
United States
The University of Texas MD Anderson Cancer Center, Gynecologic Oncology Center
Houston, Texas 77030
United States
START San Antonio
San Antonio, Texas 78229
United States
Wisconsin Institute Medical Research- UW Cancer Connect
Madison, Wisconsin 53705
United States
Princess Margaret Cancer Center
Toronto, Ontario M5G 2M9
Canada
McGill University
Montreal, Quebec H4A3J1
Canada
National Cancer Center
Goyang-si, Gyeonggi-do 410-763
South Korea
Seoul National University Hospital Bundang Hospital
Seongnam-si, Gyeonnggi-Do 463-707
South Korea
Yonsei University Health System Severance Hospital
Seoul, 03722
South Korea
Gangnam Severance Hospital
Seoul, 06273
South Korea
Korea University Guro Hospital
Seoul, 08308
South Korea
Seoul National University Hospital
Seoul, 110-74
South Korea
Samsung Medical Center
Seoul, 135-710
South Korea