A Study of Lorigerlimab in Participants With Advanced Solid Tumors
NCT ID: NCT06730347
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-05-01
2027-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PROC Cohort
Lorigerlimab IV every 21 days
Lorigerlimab
Bispecific DART protein binding PD-1 and CTLA-4
CCGC Cohort
Lorigerlimab IV every 21 days
Lorigerlimab
Bispecific DART protein binding PD-1 and CTLA-4
Interventions
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Lorigerlimab
Bispecific DART protein binding PD-1 and CTLA-4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed clear cell carcinoma of the ovary (including primary peritoneal and fallopian tube), endometrium, vagina, vulva, or cervix.
* Persistent or recurrent disease with documented disease progression.
* Participants with PROC must have received at least 1 but not more than 3 prior lines of therapy for PROC.
* Participants with CCGC must have received at least 1 prior line of therapy for CCGC.
* Participants with a known breast cancer (BRCA) mutation (germline or somatic) must have received a a Poly ADP-ribose polymerase (PARP) inhibitor, if locally approved and available, and experienced disease progression or intolerance on the PARP inhibitor.
* Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
* Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue, or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.
* Participants have acceptable physical condition and laboratory values.
* Participants of childbearing potential must agree to use highly effective methods of birth control.
* Participants must not be pregnant, planning to be pregnant, or breastfeeding.
Exclusion Criteria
* Primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum- containing chemotherapy.
* Prior treatment with a checkpoint inhibitor (e.g., anti-PD-1/PD-L1, anti-PD-L2, anti-CTLA-4). Prior use of immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4) is allowed for clear cell endometrial and clear cell cervical cancer.
* Active brain metastases or leptomeningeal metastases.
* Prior stem cell, tissue, or solid organ transplant.
* Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 3 years from first dose of study treatment. Participants with another tumor that has a negligible risk for metastasis or death such as, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast are eligible.
18 Years
FEMALE
No
Sponsors
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MacroGenics
INDUSTRY
Responsible Party
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Principal Investigators
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Pepi Pencheva
Role: STUDY_DIRECTOR
MacroGenics
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Surya Nagesh
Role: primary
Chad Hamilton
Role: primary
Judy Phan
Role: primary
Sarah Crafton
Role: primary
Mariana Gallardo
Role: primary
Alison Procter
Role: primary
Claire Kostechka
Role: primary
Stephanie Lheureux
Role: primary
Phuong Nam Natalie Nguyen
Role: primary
Myong Cheol Lim
Role: primary
Yong Beom Kim
Role: primary
Yujeong Huh
Role: primary
Mina Jang
Role: primary
Jin Hwa Hong
Role: primary
Jae-Weon Kim
Role: primary
Jeong-Won Lee
Role: primary
Other Identifiers
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CP-MGD019-03
Identifier Type: -
Identifier Source: org_study_id