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NCT06730347 · ClinicalTrials.gov record · last posted 2026-06-02

A Study of Lorigerlimab in Participants With Advanced Solid Tumors

StatusRecruiting
PhasePhase 2
Started2025-05-01
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from the ClinicalTrials.gov record
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 80 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.

Protocol amendment history 4 changes detected by DataLookout

2026-06-03
notable
Enrollment increased: 60 → 80 participants
2026-06-03
minor
Trial arms changed: 2 → 4
2026-06-03
notable
Primary completion pushed: 2027-02 → 2027-07
2026-06-03
minor
Completion pushed: 2027-08 → 2027-12
Trial Details
NCT Number NCT06730347
Lead Sponsor MacroGenics
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 +3 more
Enrollment 80 participants
Start Date 2025-05-01
Primary Completion 2027-07 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-02