RecruitingPhase 2NCT06730347

A Study of Lorigerlimab in Participants With Advanced Solid Tumors

A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors


Sponsor

MacroGenics

Enrollment

60 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new immunotherapy drug called lorigerlimab in women with two specific types of advanced, hard-to-treat gynecological cancers: platinum-resistant ovarian cancer (PROC) and clear cell gynecological cancers (CCGC) affecting the ovaries, endometrium, vagina, vulva, or cervix. **You may be eligible if...** - You have been confirmed by biopsy to have high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that is resistant to platinum chemotherapy, OR - You have confirmed clear cell cancer of the ovary, endometrium, vagina, vulva, or cervix - Your cancer has progressed or come back after prior treatment - You have received 1 to 3 prior lines of therapy (for ovarian cancer) or at least 1 prior line (for clear cell cancer) - If you have a BRCA gene mutation, you have previously received a PARP inhibitor - You have at least one measurable tumor on scans - You are willing to provide a tumor biopsy or have archived tissue available **You may NOT be eligible if...** - You have primary platinum-refractory disease (cancer that never responded to first-line platinum therapy) - You have previously received checkpoint inhibitor immunotherapy (anti-PD-1, anti-PD-L1, anti-CTLA-4) for ovarian cancer — though prior use for clear cell endometrial or cervical cancers may be allowed - You have active brain metastases - You have had an organ or stem cell transplant - You are pregnant, planning to be pregnant, or breastfeeding - You have another active cancer diagnosed within the past 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALLorigerlimab

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06730347


Related Trials