Recruiting
Phase 2

Lorigerlimab

Sponsor:

MacroGenics

Code:

NCT06730347

Conditions

Platinum-resistant Ovarian Cancer

Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma

Clear Cell Adenocarcinoma of Ovary

Clear Cell Adenocarcinoma of Vulva

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lorigerlimab

Study Details

Brief summary:

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.

Conditions

Platinum-resistant Ovarian Cancer

Platinum-Resistant Fallopian Tube Carcinoma

Platinum-Resistant Primary Peritoneal Carcinoma

Clear Cell Adenocarcinoma of Ovary

Clear Cell Adenocarcinoma of Vulva

Study ID

NCT06730347

Start date

May 1, 2025

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 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.
  • Paracentesis (removal of fluid from the abdomen) within 4 weeks prior to initiation of study treatment.
  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A (PROC) high dose

Lorigerlimab 6 mg/kg IV every 21 days

experimental: Cohort A (PROC) low dose

Lorigerlimab 3 mg/kg IV every 21 days

experimental: Cohort B (CCGC)

Lorigerlimab 6 mg/kg IV every 21 days

experimental: Cohort C (CCGC)

Lorigerlimab 3 mg/kg IV every 21 days

Interventions

Lorigerlimab

Bispecific DART protein binding PD-1 and CTLA-4

Primary outcome measure

  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator [ Time Frame: Throughout the study up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Global Trial Manager

301-251-5172info@macrogenics.com

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Salani Ritu, MD

Ochsner MD Anderson Cancer Center

Recruiting

New Orleans, Louisiana, United States, 70115

Principal Investigator:

Chad Hamilton, MD

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Principal Investigator:

Manish Sharma, MD

West Penn Allegheny Health

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Principal Investigator:

Sarah Crafton, MD

The University of Texas MD Anderson Cancer Center, Gynecologic Oncology Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Amir Jazaeri, MD

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Drew Rasco, MD

Wisconsin Institute Medical Research- UW Cancer Connect

Recruiting

Madison, Wisconsin, United States, 53705

Principal Investigator:

Janelle Sobecki, MD

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Principal Investigator:

Stephanie Lheureux, MD

McGill University

Recruiting

Montreal, Quebec, Canada, H4A3J1

Principal Investigator:

Lucy Gilbert, MD

More Information

Sponsor

MacroGenics

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by MacroGenics on 2026-06-02.