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RECRUITING
NCT06730347
PHASE2

A Study of Lorigerlimab in Participants With Advanced Solid Tumors

Sponsor: MacroGenics

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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