NCT05551117

A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors

A Phase 2, Open-label, Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: MacroGenics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Castration-Resistant Prostatic Cancer
• Androgen-Independent Prostatic Cancer
• Androgen-Insensitive Prostatic Cancer
• Androgen-Resistant Prostatic Cancer
• Hormone Refractory Prostatic Cancer
• Anal Cancer
• Anal Neoplasm
• Carcinoma, Squamous Cell of Head and Neck
• Head and Neck Squamous Cell Carcinoma
• Laryngeal Squamous Cell Carcinoma
• Oral Squamous Cell Carcinoma
• Malignant Melanoma
• Melanoma
• Non-small Cell Lung Cancer
• Non-small Cell Carcinoma
• Small-cell Lung Cancer
• Small Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	vobramitamab duocarmazine 2.0 mg (Arm A)	2.0 mg/kg intravenous (IV) every 4 weeks
BIOLOGICAL	vobramitamab duocarmazine 2.7 mg (Arm B)	2.7 mg.kg IV every 4 weeks
BIOLOGICAL	vobramitamab duocarmazine	2.7 mg.kg IV every 4 weeks
DRUG	Abiraterone	1000 mg once daily
DRUG	Enzalutamide	160 mg daily

Timeline

• Start date: 2023-06-13
• Primary completion: 2024-07-04
• Completion: 2025-01-23
• First posted: 2022-09-22
• Last updated: 2026-02-09
• Results posted: 2026-02-09

Locations

63 sites across 9 countries: United States, Australia, Belgium, France, Italy, Poland, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study