Actively Recruiting
A Study of Lorigerlimab in Participants With Advanced Solid Tumors
Led by MacroGenics · Updated on 2026-03-05
60
Participants Needed
16
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Lorigerlimab in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed high-grade serous epithelial ovarian cancer, including primary peritoneal, or fallopian tube cancer, resistant to platinum based chemotherapy. OR
- 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.
You will not qualify if you...
- Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
- 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 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.
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Trial Site Locations
Total: 16 locations
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
2
Ochsner MD Anderson Cancer Center
New Orleans, Louisiana, United States, 70115
Actively Recruiting
3
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
4
West Penn Allegheny Health
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
5
Mays Clinic
Houston, Texas, United States, 77030
Actively Recruiting
6
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
7
Wisconsin Institute Medical Research- UW Cancer Connect
Madison, Wisconsin, United States, 53705
Actively Recruiting
8
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
9
McGill University
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
10
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 410-763
Actively Recruiting
11
Seoul National University Hospital Bundang Hospital
Seongnam-si, Gyeonnggi-Do, South Korea, 463-707
Actively Recruiting
12
Yonsei University Health System Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
13
Gangnam Severance Hospital
Seoul, South Korea, 06273
Actively Recruiting
14
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
15
Seoul National University Hospital
Seoul, South Korea, 110-74
Actively Recruiting
16
Samsung Medical Center
Seoul, South Korea, 135-710
Actively Recruiting
Research Team
G
Global Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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