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NCT06730347 · ClinicalTrials.gov registry record · Phase 2
A Study of Lorigerlimab in Participants With Advanced Solid Tumors
A Phase 2 study of Platinum-resistant Ovarian Cancer and Platinum-Resistant Fallopian Tube Carcinoma, sponsored by MacroGenics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 16
- Study locations
NCT06730347: Recruiting Phase 2 study of Platinum-resistant Ovarian Cancer and Platinum-Resistant Fallopian Tube Carcinoma, sponsored by MacroGenics.
NCT06730347 is a Phase 2 study of Platinum-resistant Ovarian Cancer and Platinum-Resistant Fallopian Tube Carcinoma that is actively recruiting participants, run by MacroGenics. The registered enrollment target is 60 participants, below the 182-participant average among 17 other Platinum-resistant Ovarian Cancer trials with a reported enrollment target (67% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06730347, a Phase 2 study of Platinum-resistant Ovarian Cancer and Platinum-Resistant Fallopian Tube Carcinoma, is actively recruiting participants, sponsored by MacroGenics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 16
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Lorigerlimab
Study Locations (16)
Other
- Yonsei University Health System Severance Hospital - Seoul
- Gangnam Severance Hospital - Seoul
- Korea University Guro Hospital - Seoul
- Seoul National University Hospital - Seoul
- Samsung Medical Center - Seoul
Texas
- Mays Clinic - Houston
- START San Antonio - San Antonio
California
- UCLA - Los Angeles
Louisiana
- Ochsner MD Anderson Cancer Center - New Orleans
Michigan
- START Midwest - Grand Rapids
Pennsylvania
- West Penn Allegheny Health - Pittsburgh
Wisconsin
- Wisconsin Institute Medical Research- UW Cancer Connect - Madison
Ontario
- Princess Margaret Cancer Center - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-05-01 |
| Est. Completion | 2027-08 |
| Phase | Phase 2 |
What NCT06730347 shows while recruiting
NCT06730347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 182-participant average among 17 other Platinum-resistant Ovarian Cancer trials with a reported enrollment target (67% lower).
The record links to 10 conditions, with Platinum-resistant Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which Lorigerlimab is the first listed.
NCT06730347 lists 16 locations in 11 states (Other, Texas, California).
Frequently Asked Questions
What is clinical trial NCT06730347 about?
NCT06730347 is a clinical study titled "A Study of Lorigerlimab in Participants With Advanced Solid Tumors". 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 ...
What is the current status of trial NCT06730347?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-05-01. Estimated completion is 2027-08.
What conditions does trial NCT06730347 study?
This clinical trial studies the following 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.
What interventions are being tested in trial NCT06730347?
The interventions under investigation include: Lorigerlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06730347?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06730347 being conducted?
This trial has 16 study locations across California, Louisiana, Michigan, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06730347's enrollment target sits among peer trials
60 13th of 17 higher than 5 of 17 other Platinum-resistant Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Platinum-resistant Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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