A Study of Lorigerlimab in Participants With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
Lorigerlimab: Bispecific DART protein binding PD-1 and CTLA-4
Study 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
Primary outcome measure(s)
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator — Throughout the study up to approximately 2 years
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.
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| UCLA | Los Angeles | California | Recruiting |
| Ochsner MD Anderson Cancer Center | New Orleans | Louisiana | Recruiting |
| START Midwest | Grand Rapids | Michigan | Recruiting |
| West Penn Allegheny Health | Pittsburgh | Pennsylvania | Recruiting |
| The University of Texas MD Anderson Cancer Center, Gynecologic Oncology Center | Houston | Texas | Recruiting |
| START San Antonio | San Antonio | Texas | Recruiting |
| Wisconsin Institute Medical Research- UW Cancer Connect | Madison | Wisconsin | Recruiting |
| Princess Margaret Cancer Center | Toronto | Ontario | Recruiting |
| McGill University | Montreal | Quebec | Recruiting |
| National Cancer Center | Goyang-si | Gyeonggi-do | Recruiting |
| Seoul National University Hospital Bundang Hospital | Seongnam-si | Gyeonnggi-Do | Recruiting |
| Yonsei University Health System Severance Hospital | Seoul | South Korea | Recruiting |
| Gangnam Severance Hospital | Seoul | South Korea | Recruiting |
| Korea University Guro Hospital | Seoul | South Korea | Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
More MacroGenics trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06730347 on ClinicalTrials.gov ↗ ← All trials in the USA