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Lorigerlimab for advanced platinum‑resistant and clear‑cell gynecologic cancers

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

Phase 2 Interventional MacroGenics · NCT06730347

This trial will test lorigerlimab given by IV every three weeks in people with platinum‑resistant ovarian, fallopian tube, primary peritoneal, or clear‑cell gynecologic cancers.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexFemale
SponsorMacroGenics Industry-sponsored
Drugs / interventionschemotherapy, lorigerlimab
Locations16 sites (Los Angeles, California and 15 other locations)
Trial IDNCT06730347 on ClinicalTrials.gov

What this trial studies

This is an open‑label Phase 2 study enrolling about 60 participants to receive lorigerlimab by intravenous infusion on Day 1 of a 21‑day cycle. Treatment continues until cancer progression, unacceptable side effects, withdrawal, or study end, with a safety follow‑up within 30 days of stopping treatment. Participants will have routine labs and physical exams each cycle and tumor imaging about every 9 weeks for the first year then every 12 weeks thereafter. Eligible patients must have histologically confirmed specified gynecologic cancers with measurable disease and meet prior‑therapy requirements.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed platinum‑resistant high‑grade serous ovarian/fallopian tube/primary peritoneal cancer or clear‑cell gynecologic cancers who have measurable disease and the required prior lines of therapy.

Not a fit: Patients without the specified histologies, without measurable disease, or who have exceeded the allowed prior therapies are unlikely to qualify or benefit from this study.

Why it matters

Potential benefit: If effective, lorigerlimab could shrink tumors or slow cancer growth and provide a new treatment option for patients with these hard‑to‑treat gynecologic cancers.

How similar studies have performed: While checkpoint inhibitors have shown benefit in some gynecologic cancers, bispecific agents like lorigerlimab are relatively novel and have limited published clinical efficacy data so far.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 (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.

Where this trial is running

Los Angeles, California and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Platinum-resistant Ovarian CancerPlatinum-Resistant Fallopian Tube CarcinomaPlatinum-Resistant Primary Peritoneal CarcinomaClear Cell Adenocarcinoma of OvaryClear Cell Adenocarcinoma of VulvaClear Cell Adenocarcinoma of VaginaClear Cell Adenocarcinoma of CervixClear Cell Adenocarcinoma of Uterus
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.