Tests lorigerlimab in adults with advanced ovarian and related gynecologic cancers
Tests lorigerlimab in adults with platinum-resistant ovarian or clear cell gynecologic cancer.
Plain-language title generated from the registry record
Registry title: A Study of Lorigerlimab in Participants With Advanced Solid Tumors
Key facts
- Where
- Goyang-si, Seongnam-si, and Seoul, South KoreaSee the 7 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with ovarian, fallopian tube or peritoneal cancer that no longer responds to platinum chemotherapy, or with clear cell gynecologic cancer, who have already had treatment.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Persistent or recurrent cancer that has grown, with at least one tumor that can be measured (RECIST v1.1). Either high-grade serous cancer resistant to platinum chemotherapy, or clear cell cancer of the ovary, endometrium, vagina, vulva or cervix.
- Earlier treatment
- Platinum-resistant ovarian cancer: 1 to 3 earlier lines of therapy. Clear cell gynecologic cancer: at least 1 earlier line. With a known BRCA mutation, a PARP inhibitor must have been tried (if available) and stopped working or not been tolerated. No earlier checkpoint inhibitor, except in clear cell endometrial and cervical cancer.
- Biomarker or test result
- No specific marker is required. Tumor tissue from before, or a new biopsy, must be available.
Main reasons for not taking part
- Cancer that never responded to first platinum chemotherapy, or grew within 3 months of its last dose
- Active brain or leptomeningeal metastases
- Earlier stem cell, tissue or solid organ transplant
- Fluid drained from the abdomen (paracentesis) within 4 weeks before treatment
- Another cancer treated within the last 3 years (some skin and in situ cancers are allowed)
Read by machine on 9 November 2026.
Where in South Korea
- National Cancer CenterGoyang-si, South KoreaTaking people
- Seoul National University Hospital Bundang HospitalSeongnam-si, South KoreaTaking people
- Gangnam Severance HospitalSeoul, South KoreaTaking people
- Korea University Guro HospitalSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Yonsei University Health System, Severance HospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- MacroGenics
- Trial code
- NCT06730347
- Record updated
- 2 June 2026
- Original description
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 80 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC.Read full original descriptionShow less
A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors
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 80 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.
Inclusion: 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 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: 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; Prior stem cell, tissue, or solid organ transplant; Paracentesis (removal of fluid from the abdomen) within 4 weeks prior to initiation of study treatment; 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; 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; Active brain metastases or leptomeningeal metastases.