A Study of Lorigerlimab in Participants With Advanced Solid Tumors

NCT06730347 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CP-MGD019-03
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 16

Brief 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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator

  The ORR, is defined as the percentage of patients in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.

  Throughout the study up to approximately 2 years

Secondary Outcomes (6)

• Frequency and severity of adverse events (AEs), serious AEs (SAEs), immune-related AEs (irAEs), and AEs leading to dose modifications or treatment discontinuation.

  Throughout the study, up to approximately 2 years

• Median duration of response (DoR) per RECIST 1.1 criteria

  Throughout the study, up to approximately 2.5 years

• Median progression free survival (PFS) per RECIST 1.1 criteria

  Throughout the study, up to 2.5 years

• Percent change from baseline in tumor size

  Throughout the study, up to 2.5 years

• Best percent change from baseline in tumor size

  Throughout the study, up to 2.5 years

Study Arms (2)

PROC Cohort

EXPERIMENTAL

Lorigerlimab IV every 21 days

Biological: Lorigerlimab

CCGC Cohort

EXPERIMENTAL

Lorigerlimab IV every 21 days

Biological: Lorigerlimab

Interventions

Lorigerlimab BIOLOGICAL

Bispecific DART protein binding PD-1 and CTLA-4

Also known as: MGD019

CCGC Cohort; PROC Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MacroGenics: lead

Study Sites (16)

UCLA

Los Angeles, California, 90095, United States

RECRUITING

Ochsner MD Anderson Cancer Center

New Orleans, Louisiana, 70115, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

West Penn Allegheny Health

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Mays Clinic

Houston, Texas, 77030, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Wisconsin Institute Medical Research- UW Cancer Connect

Madison, Wisconsin, 53705, United States

RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

McGill University

Montreal, Quebec, H4A3J1, Canada

RECRUITING

National Cancer Center

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

RECRUITING

Seoul National University Hospital Bundang Hospital

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

RECRUITING

Yonsei University Health System Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, 06273, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 110-74, South Korea

RECRUITING

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Pepi Pencheva

  MacroGenics

  STUDY DIRECTOR

Central Study Contacts

Global Trial Manager

CONTACT

301-251-5172; info@macrogenics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CA (2); KR (7)