Trials / Recruiting
RecruitingNCT06730347
A Study of Lorigerlimab in Participants With Advanced Solid Tumors
A Phase 2 Multicohort Study to Evaluate Lorigerlimab in Participants With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- MacroGenics · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Lorigerlimab | Bispecific DART protein binding PD-1 and CTLA-4 |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2027-02-01
- Completion
- 2027-08-01
- First posted
- 2024-12-12
- Last updated
- 2026-03-05
Locations
16 sites across 3 countries: United States, Canada, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06730347. Inclusion in this directory is not an endorsement.