Study on Lorigerlimab for Treating Advanced Solid Tumors

Sponsor: MacroGenics

Sponsor score: 40

ClinicalTrials ID:NCT06730347

This clinical trial is testing the safety and effectiveness of a new drug, lorigerlimab, in patients with advanced ovarian or clear cell gynecologic cancers that are resistant to standard treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment called lorigerlimab for patients with advanced ovarian cancer that doesn't respond to platinum-based chemotherapy, or clear cell gynecologic cancer. About 60 participants will receive lorigerlimab through an IV every 21 days. The treatment will continue until the cancer progresses, side effects become too severe, the participant chooses to stop, or the study ends. Participants will be closely monitored for side effects and their tumor status will be checked regularly. After stopping treatment, participants will have follow-up assessments to monitor their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of high-grade serous ovarian cancer or clear cell gynecologic cancer that is resistant to platinum-based chemotherapy.
  • Have persistent or returning cancer with documented progression.
  • For ovarian cancer, must have had 1 to 3 previous treatments.
  • For clear cell gynecologic cancer, must have had at least 1 previous treatment.
  • If you have a BRCA mutation, you must have tried a PARP inhibitor if available and experienced progression or intolerance.
  • Have at least one measurable tumor.
  • Be willing to provide a tumor sample for testing.
  • Be in good physical condition with acceptable lab results.
  • Agree to use effective birth control if of childbearing potential.
  • Must not be pregnant, planning to become pregnant, or breastfeeding.

Exclusion Criteria

  • Have any medical or psychiatric condition that affects your ability to participate in the study.
  • Have cancer that did not respond to initial platinum-based chemotherapy or progressed within 3 months of treatment.
  • Have previously been treated with a checkpoint inhibitor.
  • Have active cancer spread to the brain or spinal fluid.
  • Have had a stem cell, tissue, or organ transplant.
  • Have another cancer that was treated within the last 3 years, except for certain low-risk cancers like controlled skin cancer or carcinoma in situ.

Locations

FACILITYZIPCITYSTATE
UCLA90095Los AngelesCalifornia
Ochsner MD Anderson Cancer Center70115New OrleansLouisiana
START Midwest49546Grand RapidsMichigan
MD Anderson Cooper08103CamdenNew Jersey
West Penn Allegheny Health15224PittsburghPennsylvania
Mays Clinic77030HoustonTexas
START San Antonio78229San AntonioTexas
Wisconsin Institute Medical Research- UW Cancer Connect53705MadisonWisconsin

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