Actively Recruiting
A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors
Led by MacroGenics · Updated on 2026-06-02
80
Participants Needed
16
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating lorigerlimab, a bispecific DART protein targeting PD-1 and CTLA-4, in participants with platinum-resistant ovarian cancer or clear cell gynecologic cancers. This open-label Phase 2 study aims to assess the effectiveness and safety of lorigerlimab in these advanced solid tumors. Approximately 80 participants will be enrolled to explore its impact on tumor response and disease control. Participants will receive lorigerlimab through intravenous infusion every 21 days at doses of either 3 mg/kg or 6 mg/kg depending on their study cohort. Treatment will continue until cancer progression, unacceptable side effects, withdrawal, or study completion. Different cohorts include those with platinum-resistant ovarian cancer and clear cell gynecologic cancers, with dosing tailored to each group. During the study, participants will be closely monitored with physical exams and lab tests every treatment cycle. Tumor assessments will occur about every 9 weeks in the first year and every 12 weeks afterward. Safety follow-up will happen within 30 days after stopping treatment. Those stopping treatment for reasons other than progression will have continued tumor marker and imaging checks every 12 weeks. Participants whose cancer progresses will enter a 6-month survival follow-up. The primary measure is the objective tumor response rate assessed by RECIST criteria over up to 2 years.
CONDITIONS
Brief 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, endometrium, vagina, vulva, or cervix
- Persistent or recurrent disease with documented progression
- For platinum-resistant ovarian cancer, 1 to 3 prior lines of therapy
- For clear cell gynecologic cancers, at least 1 prior line of therapy
- Participants with BRCA mutation must have received a PARP inhibitor if available and experienced progression or intolerance
- At least one measurable lesion by RECIST v1.1
- Available archival tumor tissue or willingness to undergo biopsy
- Acceptable physical condition and lab values
- Participants of childbearing potential must agree to use effective birth control
- Not pregnant, planning pregnancy, or breastfeeding
You will not qualify if you...
- Any medical or psychiatric condition that impairs ability to receive or comply with treatment or study procedures
- Primary platinum-refractory disease (no response or progression within 3 months of first-line platinum chemotherapy)
- Prior treatment with checkpoint inhibitors except in clear cell endometrial or cervical cancer
- Active brain or leptomeningeal metastases
- Prior stem cell, tissue, or organ transplant
- Paracentesis within 4 weeks before starting study treatment
- Another hematologic or solid tumor stage 1 or higher within 3 years unless low risk such as controlled skin cancers or carcinoma in situ of cervix or breast
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive Lorigerlimab infusions every 21 days as part of the study treatment.
Infusions every 3 weeks
Duration - Up to approximately 6 months after treatment
Participants are monitored for response and safety after treatment ends.
Regular visits for assessments
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
The University of Texas MD Anderson Cancer Center, Gynecologic Oncology Center
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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