A Study of Lorigerlimab in Participants With Advanced Solid Tumors

Description

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 60 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, Clear Cell Adenocarcinoma of Vagina, Clear Cell Adenocarcinoma of Cervix, Clear Cell Adenocarcinoma of Uterus, Clear Cell Adenocarcinoma of Fallopian Tube, Clear Cell Adenocarcinoma of Peritoneum, Endometrial Cancer

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Study Overview

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Study Details

Study overview

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 60 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.

A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors

A Study of Lorigerlimab in Participants With Advanced Solid Tumors

Condition
Platinum-resistant Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

UCLA, Los Angeles, California, United States, 90095

New Orleans

Ochsner MD Anderson Cancer Center, New Orleans, Louisiana, United States, 70115

Grand Rapids

START Midwest, Grand Rapids, Michigan, United States, 49546

Pittsburgh

West Penn Allegheny Health, Pittsburgh, Pennsylvania, United States, 15224

Houston

Mays Clinic, Houston, Texas, United States, 77030

San Antonio

START San Antonio, San Antonio, Texas, United States, 78229

Madison

Wisconsin Institute Medical Research- UW Cancer Connect, Madison, Wisconsin, United States, 53705

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval, or cervical cancer.
  • * 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 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.
  • * 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).
  • * Active brain metastases or leptomeningeal metastases.
  • * Prior stem cell, tissue, or solid organ transplant.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

MacroGenics,

Pepi Pencheva, STUDY_DIRECTOR, MacroGenics

Study Record Dates

2027-08