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

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

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

Sponsors & Collaborators

• MacroGenics

  lead INDUSTRY

Principal Investigators

• Liudmila Schafer, M.D. · MacroGenics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-13

Primary Completion

2024-07-04

Completion

2025-01-23

FDA Drug

Yes

Countries

• United States
• Australia
• Belgium
• France
• Italy
• Poland
• South Korea
• Spain
• United Kingdom

Study Locations