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

NCT05551117 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CP-MGC018-03
• Study Type: interventional
• Target: 192
• Locations: 9 countries
• Sites: 63

Brief 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 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; Anal Cancer

Outcome Measures

Primary Outcomes (2)

• Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator

  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.

  Assessed every 8 weeks for six months. Six month data reported.

• Part 2: Objective Response Rate (ORR) Per Investigator Assessment of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Criteria

  The ORR is defined as the percentage of participants in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST version 1.1 criterial CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.

  Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.

Secondary Outcomes (12)

• Part 1: ORR Per PCWG3 Criteria as Determined by the Investigator

  Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months,

• Part 1: Median Duration of Response (DoR) Per PCWG3 Criteria as Determined by the Investigator

  Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.

• Part 1: Mean Best Tumor Size Change Over Time

  Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.

• Part 1: Prostate-specific Cancer Antigen (PSA) Response Rate Per PCWG3 Criteria

  Every 4 weeks throughout study participation. Average duration 10 months.

• Part 1: Time to PSA Progression Per PCWG3 Criteria

  Every 4 weeks throughout study participation. Average duration of participation, 10 months.

Study Arms (4)

Part 1: MGC018 2.0 mg (Arm A)

EXPERIMENTAL

MGC018 2.0 mg/kg every 4 weeks

Biological: vobramitamab duocarmazine 2.0 mg (Arm A)

Part 1: MGC018 2.7 mg (Arm B)

EXPERIMENTAL

MGC018 2.7 mg/kg every 4 weeks

Biological: vobramitamab duocarmazine 2.7 mg (Arm B)

Part 2

EXPERIMENTAL

MGC018 2.7 mg/kg every 4 weeks

Biological: vobramitamab duocarmazine

Part 1: Control Arm

ACTIVE COMPARATOR

Patients are administered abiraterone or enzalutamide

Drug: Abiraterone; Drug: Enzalutamide

Interventions

vobramitamab duocarmazine 2.0 mg (Arm A) BIOLOGICAL

2.0 mg/kg intravenous (IV) every 4 weeks

Also known as: MGC018

Part 1: MGC018 2.0 mg (Arm A)

vobramitamab duocarmazine 2.7 mg (Arm B) BIOLOGICAL

2.7 mg.kg IV every 4 weeks

Also known as: MGC018

Part 1: MGC018 2.7 mg (Arm B)

vobramitamab duocarmazine BIOLOGICAL

2.7 mg.kg IV every 4 weeks

Also known as: MGC018

Part 2

Abiraterone DRUG

1000 mg once daily

Part 1: Control Arm

Enzalutamide DRUG

160 mg daily

Part 1: Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1 only: Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
• Part 2 only: Histologically confirmed SCC or the anus, melanoma, HNSCC, squamous NSCLC, or SCLC.
• Part 1 only: Received 1 prior ARAT for metastatic or non-metastatic, castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of \<60 days used as bridging to lutetium-177 is permitted. Up to 3 total prior lines of therapy for mCRPC are permitted..
• Part 2 only: At least 1 prior line of systemic therapy for unresectable or metastatic disease and no more than 2 prior lines of cytotoxic chemotherapy. Participants with HNSCC or melanoma must have received prior PD-1 or PD-L1 inhibitor for advanced or metastatic disease.
• All participants must have ≥ 1 metastatic lesion, according to RECIST 1.1 or PCWG3 criteria, that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained ≤ 28 days prior to initiation of study treatment.
• All participants must have tumor progression, according to disease-specific criteria, following their most recent anti-cancer therapy.
• All participants must have and available archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
• All participants have acceptable physical condition and laboratory values.
• All participants of childbearing potential must agree to use highly effective methods of birth control.
• All participants must not be pregnant, planning to be pregnant, or breastfeeding.

You may not qualify if:

• Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
• Part 1 only: Received \>1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of \<60 days used as bridging for lutetium-177 is permitted.
• Part 1 only: Received \>3 total prior therapies for mCRPC
• Part 1 only: Participants with known BRCA or ATM mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated.
• Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years from first dose of study treatment. Participants who had curative therapy for non-melanomatous skin cancer or for localized malignancy are eligible.
• Untreated, symptomatic central nervous system (CNS) metastasis.
• Prior treatment with any B7-H3 targeted agent for cancer,
• Contradictions to the use of corticosteroid treatment
• Prior stem cell, tissue, or solid organ transplant.
• Part 1 only: Use of products that have published anti-prostate cancer activity or are known to decrease PSA.

Sponsors & Collaborators

• MacroGenics: lead

Study Sites (63)

Compassionate Cancer Care Medical Group

Fountain Valley, California, 92708, United States

Location

University of California Los Angeles (UCLA) Community Cancer Care

Los Angeles, California, 90095, United States

Location

The University of Florida Health System - UF Health Urology - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

Location

Pontchartrain Cancer Center

Covington, Louisiana, 70433, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Barbara Ann Karmanos Cancer Institute - Hudson-Webber Cancer Research Center

Detroit, Michigan, 48201, United States

Location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

VA Portland Health Care Services

Portland, Oregon, 97239, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Virginia Cancer Specalists

Fairfax, Virginia, 22031, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Ramsay Health Care - Westmead Private Hospital

Westmead, New South Wales, 2145, Australia

Location

The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)

Woolloongabba, Queensland, 4102, Australia

Location

Cabrini Health- Malvern

Malvern, Victoria, 3144, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Brussles, 1200, Belgium

Location

(Grand Hopital de Charleroi) GHDC

Charleroi, Hainaut, 6000, Belgium

Location

Centre Hospitalier de Ardenne - Libramont - Clinique du Sein

Libramont, Luxembourg, 6800, Belgium

Location

Centre Hospitalier Universitaire (CHU) - Universite Catholique de Louvain (UCL) - Namur - Site Godinne (Cliniques Universitaires UCL de Mont-Godinne)

Godinne, Namur, 5300, Belgium

Location

Algemeen Ziekenhuis Maria Middelares

Ghent, 9000, Belgium

Location

Centre Antoine-Lacassagne

Nice, AM, 06189, France

Location

Institut de Cancerologie Strasbourg Europe (ICANS)

Strasbourg, Bas Rhin, 67200, France

Location

Institut Bergonié

Bordeaux, Gironde, 33076, France

Location

Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

Montpellier, Herault, 34298, France

Location

Centre Hospitalier Privé Saint-Grégoire

Saint-Grégoire, Ille Et Vilaine, 35760, France

Location

Clinique Victor Hugo

Le Mans, Sarthe, 72000, France

Location

Gustave Roussy

Villejuif, Val De Marne, 94800, France

Location

CHRU Brest

Brest, 29200, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, Île-de-France Region, 94160, France

Location

Hopital Foch

Suresnes, Île-de-France Region, 92150, France

Location

AOU San Luigi Gonzaga Oncology Department

Orbassano, TO, 10049, Italy

Location

Ospedale dell'Angelo

Mestre, Venice, 30174, Italy

Location

Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence

Florence, 50134, Italy

Location

Istituto Oncologico Veneto

Padua, 35128, Italy

Location

Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara

Trento, 38122, Italy

Location

Szpital im. Fryderyka Chopina

Otwock, Masovian Voivodeship, 05-400, Poland

Location

Magodent Szpital Elblaska

Warsaw, Masovian Voivodeship, 01-748, Poland

Location

Medical Concierge Centrum Medyczne

Warsaw, Masovian Voivodeship, 02-798, Poland

Location

Grochowski Hospital

Warsaw, Masovian Voivodeship, 04-073, Poland

Location

Szpital Wojewodzki im. Mikolaja Kopernika

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

Location

Przychodnia Lekarska "KOMED"

Konin, WLKP, 62-500, Poland

Location

Kyungpook National University Chilgok Hospital

Bugok, Daegu, 41404, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Seoul National University Hopital

Seoul, 03080, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Location

Samsung Meical Cemter

Seoul, 06351, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

Location

Asan Medical Center

Seoul, 5505, South Korea

Location

Hospital Universitari Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Seville, 41013, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu I Sant Pau

Barcelona, 08036, Spain

Location

Institut Catala d'Oncologia Hospitalet

Barcelona, 08036, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27002, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

The Royal Marsden NHS Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Oxford University Hospitals NHS- Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant; Anus Neoplasms; Squamous Cell Carcinoma of Head and Neck; Melanoma; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Carcinoma, Small Cell

Interventions

abiraterone; enzalutamide

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: MacroGenics, Inc.

info@macrogenics.com

301-251-5172

Study Officials

• Liudmila Schafer, M.D.

  MacroGenics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: June 13, 2023
• Primary Completion: July 4, 2024
• Study Completion: January 23, 2025
• Last Updated: February 9, 2026
• Results First Posted: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5); AU (4); IT (5); PL (6); KR (8); GB (2); FR (11); ES (8); US (14)