Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Salani Ritu, MD (ucla)

Description

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 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.

Official Title

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

Keywords

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, Carcinoma, Adenocarcinoma, Endometrial Neoplasms, Clear Cell Adenocarcinoma, Lorigerlimab

Eligibility

Locations

  • UCLA not yet accepting patients
    Los Angeles California 90095 United States
  • START San Antonio accepting new patients
    San Antonio Texas 78229 United States
  • START Midwest accepting new patients
    Grand Rapids Michigan 49546 United States

Lead Scientist at University of California Health

  • Salani Ritu, MD (ucla)
    Professor, Obstetrics and Gynecology, Medicine. Authored (or co-authored) 157 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
MacroGenics
ID
NCT06730347
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated