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A Study of Lorigerlimab in Participants With Advanced Solid Tumors

NCT06730347 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-05

No results posted yet for this study

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.

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

Interventions

BIOLOGICAL

Lorigerlimab

Bispecific DART protein binding PD-1 and CTLA-4

Sponsors & Collaborators

Principal Investigators

  • Pepi Pencheva · MacroGenics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-02-28
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06730347 on ClinicalTrials.gov