A Study of Lorigerlimab in Participants With Advanced Solid Tumors

May 29, 2026 updated by: MacroGenics

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Center
        • Principal Investigator:
          • Stephanie Lheureux, MD
        • Contact:
          • Stephanie Lheureux
    • Quebec
      • Montreal, Quebec, Canada, H4A3J1
        • Recruiting
        • McGill University
        • Principal Investigator:
          • Lucy Gilbert, MD
        • Contact:
          • Phuong Nam Natalie Nguyen
  • South Korea
      • Seoul, South Korea, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
          • Jin Hwa Hong
        • Principal Investigator:
          • Jin Hwa Hong, MD
      • Seoul, South Korea, 06273
        • Recruiting
        • Gangnam Severance Hospital
        • Principal Investigator:
          • Jae-Hoon Kim, MD
        • Contact:
          • Mina Jang
      • Seoul, South Korea, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Jeong-Won Lee
        • Principal Investigator:
          • Jeong-Won Lee, MD
      • Seoul, South Korea, 03722
        • Recruiting
        • Yonsei University Health System Severance Hospital
        • Contact:
          • Yujeong Huh
        • Principal Investigator:
          • Jung Yun Lee, MD
      • Seoul, South Korea, 110-74
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Jae-Weon Kim
        • Principal Investigator:
          • Jae-Weon Kim, MD
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 410-763
        • Recruiting
        • National Cancer Center
        • Principal Investigator:
          • Myong Cheol Lim, MD
        • Contact:
          • Myong Cheol Lim
    • Gyeonnggi-Do
      • Seongnam-si, Gyeonnggi-Do, South Korea, 463-707
        • Recruiting
        • Seoul National University Hospital Bundang Hospital
        • Contact:
          • Yong Beom Kim
        • Principal Investigator:
          • Yong Beom Kim, MD
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA
        • Contact:
          • Surya Nagesh
        • Principal Investigator:
          • Salani Ritu, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • Ochsner MD Anderson Cancer Center
        • Contact:
          • Chad Hamilton
        • Principal Investigator:
          • Chad Hamilton, MD
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • START Midwest
        • Principal Investigator:
          • Manish Sharma, MD
        • Contact:
          • Judy Phan
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • West Penn Allegheny Health
        • Principal Investigator:
          • Sarah Crafton, MD
        • Contact:
          • Sarah Crafton
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center, Gynecologic Oncology Center
        • Principal Investigator:
          • Amir Jazaeri, MD
        • Contact:
          • Mariana Gallardo
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • START San Antonio
        • Principal Investigator:
          • Drew Rasco, MD
        • Contact:
          • Alison Procter
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • Wisconsin Institute Medical Research- UW Cancer Connect
        • Principal Investigator:
          • Janelle Sobecki, MD
        • Contact:
          • Claire Kostechka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A (PROC) high dose
Lorigerlimab 6 mg/kg IV every 21 days
Biological: Lorigerlimab
Bispecific DART protein binding PD-1 and CTLA-4
Other Names:
  • MGD019
Experimental: Cohort A (PROC) low dose
Lorigerlimab 3 mg/kg IV every 21 days
Biological: Lorigerlimab
Bispecific DART protein binding PD-1 and CTLA-4
Other Names:
  • MGD019
Experimental: Cohort B (CCGC)
Lorigerlimab 6 mg/kg IV every 21 days
Biological: Lorigerlimab
Bispecific DART protein binding PD-1 and CTLA-4
Other Names:
  • MGD019
Experimental: Cohort C (CCGC)
Lorigerlimab 3 mg/kg IV every 21 days
Biological: Lorigerlimab
Bispecific DART protein binding PD-1 and CTLA-4
Other Names:
  • MGD019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

The ORR, is defined as the percentage of patients in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria.

CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.
Throughout the study up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median duration of response (DoR) per RECIST 1.1 criteria
Time Frame: Throughout the study, up to approximately 2.5 years
The DoR will be calculated per RECIST v1.1 criteria, as determined by the investigator, from the date of initial tumor response (CR or PR) to the date of first documented progressive disease (PD) or death from any cause, whichever occurs first.
Throughout the study, up to approximately 2.5 years
Median progression free survival (PFS) per RECIST 1.1 criteria
Time Frame: Throughout the study, up to 2.5 years
PFS is defined as the time from the first dose of study treatment to the date of documented PD or death from any cause, whichever occurs first.
Throughout the study, up to 2.5 years
Percent change from baseline in tumor size
Time Frame: Throughout the study, up to 2.5 years
Tumor size is defined as the sum of diameters of the target lesions.
Throughout the study, up to 2.5 years
Best percent change from baseline in tumor size
Time Frame: Throughout the study, up to 2.5 years
Tumor size is defined as the sum of diameters of the target lesions.
Throughout the study, up to 2.5 years
Disease control rate (DCR)
Time Frame: Throughout the study, up to 2.5 years
DCR, per RECIST v1.1 criteria, as determined by the investigator, is defined as the proportion of participants in the response evaluable population who achieve a CR, PR or stable disease for at least 3 months.
Throughout the study, up to 2.5 years
Frequency and severity of adverse events (AEs), serious AEs (SAEs), immune-related AEs (irAEs), and AEs leading to dose modifications or treatment discontinuation.
Time Frame: Throughout the study, up to approximately 2 years
Throughout the study, up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MacroGenics

Investigators

  • Study Director: Pepi Pencheva, MacroGenics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-MGD019-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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