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NCT05293496 · ClinicalTrials.gov registry record · Phase 1
A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by MacroGenics.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT05293496 is a Phase 1 study that has completed, run by MacroGenics. The registered enrollment target is 31 participants.
The verdict
NCT05293496, a Phase 1 study, has completed, sponsored by MacroGenics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
Study CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab (MGD019). The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors including, but not limited to, metastatic castration-resistant prostate cancer (mCRPC), melanoma, pancreatic cancer, hepatocellular carcinoma (HCC), ovarian cancer, and renal cell carcinoma (RCC) will be enrolled. Vobramitamab duocarmazine and lorigerlimab are administered separately on Day 1 of every 4-week (28-day) cycle at the assigned dose for each cohort. Participants who do not meet criteria for study drug discontinuation may receive study drugs for up to 2 years. Tumor assessments are performed every 8 weeks (± 7 days) for the initial 6 months on study drugs, then every 12 weeks (± 21 days) until progressive disease (PD). Participants will be followed for safety throughout the study. .
Interventions
- BIOLOGICAL lorigerlimab
- BIOLOGICAL vobramitamab duocarmazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-04-19 |
| Est. Completion | 2025-08-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05293496
The ClinicalTrials.gov registry entry for NCT05293496 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MacroGenics, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which lorigerlimab is the first listed.
NCT05293496 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05293496 about?
NCT05293496 is a clinical study titled "A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors". Study CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab (MGD019). The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity. Participants with relapsed or refrac...
What is the current status of trial NCT05293496?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2022-04-19. Estimated completion is 2025-08-26.
What interventions are being tested in trial NCT05293496?
The interventions under investigation include: lorigerlimab (BIOLOGICAL), vobramitamab duocarmazine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05293496?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
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