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Platinum-resistant Ovarian CancerPhase 2NCT06730347

A Study of Lorigerlimab in Participants With Advanced Solid Tumors

A Phase 2 study testing Lorigerlimab in people with Platinum-resistant Ovarian Cancer and Platinum-Resistant Fallopian Tube Carcinoma, run by MacroGenics at 16 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Lorigerlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
16 sitesin 3 countries
Study dates
1 May 2025to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Global Trial Manager contact

301-251-5172

info@macrogenics.com

16 sites in 3 countries

United States7 sites, 7 recruiting

  • START Midwest

    Grand Rapids, Michigan, 49546

    Judy Phan

    Manish Sharma, MD

    Recruiting

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

    Houston, Texas, 77030

    Mariana Gallardo

    Amir Jazaeri, MD

    Recruiting

  • UCLA

    Los Angeles, California, 90095

    Surya Nagesh

    Salani Ritu, MD

    Recruiting

  • Wisconsin Institute Medical Research- UW Cancer Connect

    Madison, Wisconsin, 53705

    Claire Kostechka

    Janelle Sobecki, MD

    Recruiting

  • Ochsner MD Anderson Cancer Center

    New Orleans, Louisiana, 70115

    Chad Hamilton

    Chad Hamilton, MD

    Recruiting

  • West Penn Allegheny Health

    Pittsburgh, Pennsylvania, 15224

    Sarah Crafton

    Sarah Crafton, MD

    Recruiting

  • START San Antonio

    San Antonio, Texas, 78229

    Alison Procter

    Drew Rasco, MD

    Recruiting

Other trials in United States

South Korea7 sites, 7 recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-763

    Myong Cheol Lim

    Myong Cheol Lim, MD

    Recruiting

  • Seoul National University Hospital Bundang Hospital

    Seongnam-si, Gyeonnggi-Do, 463-707

    Yong Beom Kim

    Yong Beom Kim, MD

    Recruiting

  • Yonsei University Health System Severance Hospital

    Seoul, 03722

    Yujeong Huh

    Jung Yun Lee, MD

    Recruiting

  • Gangnam Severance Hospital

    Seoul, 06273

    Mina Jang

    Jae-Hoon Kim, MD

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Jin Hwa Hong

    Jin Hwa Hong, MD

    Recruiting

  • Seoul National University Hospital

    Seoul, 110-74

    Jae-Weon Kim

    Jae-Weon Kim, MD

    Recruiting

  • Samsung Medical Center

    Seoul, 135-710

    Jeong-Won Lee

    Jeong-Won Lee, MD

    Recruiting

Other trials in South Korea

Canada2 sites, 2 recruiting

  • McGill University

    Montreal, Quebec, H4A3J1

    Phuong Nam Natalie Nguyen

    Lucy Gilbert, MD

    Recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

    Stephanie Lheureux

    Stephanie Lheureux, MD

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Being tested
Lorigerlimab
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LorigerlimabBiological

    Also called MGD019

    Bispecific DART protein binding PD-1 and CTLA-4

Study groups in NCT06730347
Study groupRoleWhat they receive
Cohort A (PROC) high doseExperimentalLorigerlimab 6 mg/kg IV every 21 days
Receives: Biological: Lorigerlimab
Cohort A (PROC) low doseExperimentalLorigerlimab 3 mg/kg IV every 21 days
Receives: Biological: Lorigerlimab
Cohort B (CCGC)ExperimentalLorigerlimab 6 mg/kg IV every 21 days
Receives: Biological: Lorigerlimab
Cohort C (CCGC)ExperimentalLorigerlimab 3 mg/kg IV every 21 days
Receives: Biological: Lorigerlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator

    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.

    Measured: Throughout the study up to approximately 2 years

Secondary outcomes (6)

  1. Frequency and severity of adverse events (AEs), serious AEs (SAEs), immune-related AEs (irAEs), and AEs leading to dose modifications or treatment discontinuation.

    Measured: Throughout the study, up to approximately 2 years

  2. Median duration of response (DoR) per RECIST 1.1 criteria

    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.

    Measured: Throughout the study, up to approximately 2.5 years

  3. Median progression free survival (PFS) per RECIST 1.1 criteria

    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.

    Measured: Throughout the study, up to 2.5 years

  4. Percent change from baseline in tumor size

    Tumor size is defined as the sum of diameters of the target lesions.

    Measured: Throughout the study, up to 2.5 years

  5. Best percent change from baseline in tumor size

    Tumor size is defined as the sum of diameters of the target lesions.

    Measured: Throughout the study, up to 2.5 years

  6. Disease control rate (DCR)

    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.

    Measured: Throughout the study, up to 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start1 May 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730347
Sponsor's protocol ID
CP-MGD019-03
Status last verified
May 2026
First submitted
9 Dec 2024
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lorigerlimab in people with Platinum-resistant Ovarian Cancer and Platinum-Resistant Fallopian Tube Carcinoma, run by MacroGenics at 16 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, South Korea, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Global Trial Manager (301-251-5172, info@macrogenics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06730347.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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