A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors
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.
Arms & interventions
- BiologicalLorigerlimab
Bispecific DART protein binding PD-1 and CTLA-4
Outcome measures
Primary
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator
The ORR, is defined as the percentage of patients in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.
Time frame: Throughout the study up to approximately 2 years
Secondary
Frequency and severity of adverse events (AEs), serious AEs (SAEs), immune-related AEs (irAEs), and AEs leading to dose modifications or treatment discontinuation.
Time frame: Throughout the study, up to approximately 2 years
Median duration of response (DoR) per RECIST 1.1 criteria
Time frame: Throughout the study, up to approximately 2.5 years
Median progression free survival (PFS) per RECIST 1.1 criteria
Time frame: Throughout the study, up to 2.5 years
Percent change from baseline in tumor size
Time frame: Throughout the study, up to 2.5 years
Best percent change from baseline in tumor size
Time frame: Throughout the study, up to 2.5 years
Disease control rate (DCR)
Time frame: Throughout the study, up to 2.5 years
Eligibility criteria
Study locations (7)
UCLA
Los Angeles, California, 90095
Ochsner MD Anderson Cancer Center
New Orleans, Louisiana, 70115
START Midwest
Grand Rapids, Michigan, 49546
West Penn Allegheny Health
Pittsburgh, Pennsylvania, 15224
The University of Texas MD Anderson Cancer Center, Gynecologic Oncology Center
Houston, Texas, 77030
START San Antonio
San Antonio, Texas, 78229
Wisconsin Institute Medical Research- UW Cancer Connect
Madison, Wisconsin, 53705