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NCT05551117 · ClinicalTrials.gov registry record · Phase 2
A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
A Phase 2 study, sponsored by MacroGenics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 192
- Enrollment target
NCT05551117: Clinical Trial Phase 2 study, sponsored by MacroGenics.
NCT05551117 is a Phase 2 study that was terminated before completion, run by MacroGenics. The registered enrollment target is 192 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05551117, a Phase 2 study, was terminated before completion, sponsored by MacroGenics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 192 participants
- Enrollment target
Study Summary
Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior docetaxel-containing regimen, but no other chemotherapy agents. This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine (MGC018) in two experimental arms (2.0 mg/kg every 4 weeks \[Q4W\] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1. Part 2 of the study will enroll participants with locally advanced or metastatic solid tumors. Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab duocarmazine at a dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2. In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor.
Primary Outcome
The landmark analysis for 6 month rPFS rate will occur when all participants on Part 1 have been on study for at least 6 months.
Interventions
- DRUG Enzalutamide
- DRUG Abiraterone
- BIOLOGICAL vobramitamab duocarmazine
- BIOLOGICAL vobramitamab duocarmazine 2.0 mg (Arm A)
- BIOLOGICAL vobramitamab duocarmazine 2.7 mg (Arm B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2023-06-13 |
| Est. Completion | 2025-01-23 |
| Phase | Phase 2 |
Why NCT05551117 stopped before completion
NCT05551117 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher).
The record links to 0 conditions, and to 5 interventions - of which Enzalutamide is the first listed.
NCT05551117 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05551117 about?
NCT05551117 is a clinical study titled "A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors". Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalut...
What is the current status of trial NCT05551117?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 192 participants. The study started on 2023-06-13. Estimated completion is 2025-01-23.
What interventions are being tested in trial NCT05551117?
The interventions under investigation include: Enzalutamide (DRUG), Abiraterone (DRUG), vobramitamab duocarmazine (BIOLOGICAL), vobramitamab duocarmazine 2.0 mg (Arm A) (BIOLOGICAL), vobramitamab duocarmazine 2.7 mg (Arm B) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05551117?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05551117's enrollment target sits among peer trials
192 352nd of 2000 higher than 1,648 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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