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New drug lorigerlimab takes on Platinum-Resistant ovarian cancer

NCT ID NCT06730347

Disease control Sponsor: MacroGenics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a drug called lorigerlimab in about 80 people with advanced ovarian or clear cell gynecologic cancers that have stopped responding to platinum chemotherapy. Lorigerlimab is a bispecific antibody designed to activate the immune system against tumors. Researchers will measure how many participants' tumors shrink and monitor side effects closely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lorigerlimab (a bispecific antibody that targets PD-1 and CTLA-4 to help the immune system fight cancer)
What this could lead to
If successful, this could point toward a new treatment option for people with hard-to-treat ovarian and clear cell gynecologic cancers.
What could go wrong
This is a small, early-phase trial (80 people) with no control group, so results may not apply broadly. The drug can cause immune-related side effects, and many experimental cancer drugs fail to show enough benefit.
Why investors are watching

MacroGenics is running a phase 2 trial of lorigerlimab in about 80 patients with platinum-resistant ovarian cancer or clear cell gynecologic cancer. For a small company, this readout matters because it tests whether the drug can control tumors in a hard-to-treat group, and a clear signal could shape the drug's future value.

If it works: If lorigerlimab shows meaningful disease control and acceptable side effects, MacroGenics could have a viable treatment option for these cancers, which might attract partners or support further development.

If it fails: Phase 2 trials often fail, and if the drug does not shrink or stabilize tumors, or if side effects are too severe, the program could stall. A delay in enrollment or results would also push back any potential progress.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cervical clear cell adenocarcinoma endometrial cancer endometrial clear cell adenocarcinoma endometrium neoplasm fallopian tube carcinoma fallopian tube clear cell adenocarcinoma ovarian carcinoma ovarian clear cell adenocarcinoma ovarian clear cell cancer primary peritoneal carcinoma refractory malignant neoplasm vaginal adenocarcinoma vulvar adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clear cell adenocarcinoma of cervix Clear cell adenocarcinoma of fallopian tube Clear cell adenocarcinoma of ovary Clear cell adenocarcinoma of peritoneum Clear cell adenocarcinoma of uterus Clear cell adenocarcinoma of vagina Clear cell adenocarcinoma of vulva Endometrial cancer Platinum-resistant fallopian tube carcinoma Platinum-resistant ovarian cancer Platinum-resistant primary peritoneal carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Gangnam Severance Hospital

    RECRUITING

    Seoul, 06273, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, 08308, South Korea

  • McGill University

    RECRUITING

    Montreal, Quebec, H4A3J1, Canada

  • National Cancer Center

    RECRUITING

    Goyang-si, Gyeonggi-do, 410-763, South Korea

  • Ochsner MD Anderson Cancer Center

    RECRUITING

    New Orleans, Louisiana, 70115, United States

  • Princess Margaret Cancer Center

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 135-710, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 110-74, South Korea

  • Seoul National University Hospital Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonnggi-Do, 463-707, South Korea

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

    RECRUITING

    Houston, Texas, 77030, United States

  • UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • West Penn Allegheny Health

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Wisconsin Institute Medical Research- UW Cancer Connect

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Yonsei University Health System Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

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