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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 is a Phase 2 study that was terminated before completion, run by MacroGenics. The registered enrollment target is 192 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05551117
The ClinicalTrials.gov registry entry for NCT05551117 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 192 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 5 interventions - of which Enzalutamide is the first listed.
NCT05551117 reports 0 study locations.
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.
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