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

Last updated: February 14, 2025
Sponsor: MacroGenics
Overall Status: Completed

Phase

2

Condition

Carcinoma

Malignant Melanoma

Rectal Cancer

Treatment

Abiraterone

Enzalutamide

vobramitamab duocarmazine

Clinical Study ID

NCT05551117
CP-MGC018-03
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Part 1 only: Histologically confirmed adenocarcinoma of the prostate withoutevidence of neuroendocrine differentiation, signet cell, or small cell features.

  • Part 2 only: Histologically confirmed SCC or the anus, melanoma, HNSCC, squamousNSCLC, or SCLC.

  • Part 1 only: Received 1 prior ARAT for metastatic or non-metastatic,castration-sensitive or castration-resistant prostate cancer. A second ARAT regimenof <60 days used as bridging to lutetium-177 is permitted. Up to 3 total prior linesof therapy for mCRPC are permitted..

  • Part 2 only: At least 1 prior line of systemic therapy for unresectable ormetastatic 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 inhibitorfor advanced or metastatic disease.

  • All participants must have ≥ 1 metastatic lesion, according to RECIST 1.1 or PCWG3criteria, 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-specificcriteria, following their most recent anti-cancer therapy.

  • All participants must have and available archival or formalin-fixedparaffin-embedded (FFPE) tumor tissue sample for participants with metastasis tointernal organs

  • All participants have acceptable physical condition and laboratory values.

  • All participants of childbearing potential must agree to use highly effectivemethods of birth control.

  • All participants must not be pregnant, planning to be pregnant, or breastfeeding.

Exclusion

Exclusion Criteria:

  • Any underlying medical or psychiatric condition impairing participant's ability toreceive, tolerate, or comply with the planned treatment or study procedures.

  • Part 1 only: Received >1 prior taxane-containing regimen for prostate cancer. Asecond 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) arenot eligible unless they received prior treatment with a PARP inhibitor whereavailable, indicated and tolerated.

  • Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, lastdose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years fromfirst dose of study treatment. Participants who had curative therapy fornon-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 orare known to decrease PSA.

Study Design

Total Participants: 192
Treatment Group(s): 5
Primary Treatment: Abiraterone
Phase: 2
Study Start date:
June 13, 2023
Estimated Completion Date:
January 23, 2025

Connect with a study center

  • Ramsay Health Care - Westmead Private Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

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

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Cabrini Health- Malvern

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, Brussles 1200
    Belgium

    Site Not Available

  • (Grand Hopital de Charleroi) GHDC

    Charleroi, Hainaut 6000
    Belgium

    Site Not Available

  • Centre Hospitalier de Ardenne - Libramont - Clinique du Sein

    Libramont, Luxembourg 6800
    Belgium

    Site Not Available

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

    Godinne, Namur 5300
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Maria Middelares

    Gent, 9000
    Belgium

    Site Not Available

  • Centre Antoine-Lacassagne

    Nice Cedex 2, AM 06189
    France

    Site Not Available

  • Institut de Cancerologie Strasbourg Europe (ICANS)

    Strasbourg, Bas Rhin 67200
    France

    Site Not Available

  • Institut Bergonié

    Bordeaux, Gironde 33076
    France

    Site Not Available

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

    Montpellier, Herault 34298
    France

    Site Not Available

  • Hôpital d'Instruction des Armées Bégin

    Saint-Mandé, Ile De France 94160
    France

    Site Not Available

  • Hopital Foch

    Suresnes, Ile De France 92150
    France

    Site Not Available

  • Centre Hospitalier Privé Saint-Grégoire

    Saint-Grégoire, Ille Et Vilaine 35760
    France

    Site Not Available

  • Clinique Victor Hugo

    Le Mans, Sarthe 72000
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, Val De Marne 94800
    France

    Site Not Available

  • CHRU Brest

    Brest, 29200
    France

    Site Not Available

  • Institut Mutualiste Montsouris

    Paris, 75014
    France

    Site Not Available

  • AOU San Luigi Gonzaga Oncology Department

    Orbassano, TO 10049
    Italy

    Site Not Available

  • Ospedale dell'Angelo

    Mestre, Venice 30174
    Italy

    Site Not Available

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

    Florence, 50134
    Italy

    Site Not Available

  • Istituto Oncologico Veneto

    Padova, 35128
    Italy

    Site Not Available

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

    Trento, 38122
    Italy

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Bugok, Daegu 41404
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang, Kyonggi 10408
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju, 61469
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 5505
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Mokdong Hospital

    Seoul, 07985
    Korea, Republic of

    Site Not Available

  • Samsung Meical Cemter

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hopital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Yonsei University Health System, Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Szpital im. Fryderyka Chopina

    Otwock, Mazowieckie 05-400
    Poland

    Site Not Available

  • Grochowski Hospital

    Warszawa, Mazowieckie 04-073
    Poland

    Site Not Available

  • Magodent Szpital Elblaska

    Warszawa, Mazowieckie 01-748
    Poland

    Site Not Available

  • Medical Concierge Centrum Medyczne

    Warszawa, Mazowieckie 02-798
    Poland

    Site Not Available

  • Przychodnia Lekarska "KOMED"

    Konin, Wlkp 62-500
    Poland

    Site Not Available

  • Szpital Wojewodzki im. Mikolaja Kopernika

    Koszalin, Zachodniopomorskie 75-581
    Poland

    Site Not Available

  • Hospital Universitari Parc Taulí

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, Seville 41013
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08036
    Spain

    Site Not Available

  • Institut Catala d'Oncologia Hospitalet

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti

    Lugo, 27002
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • The Royal Marsden NHS Trust

    Sutton, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS- Churchill Hospital

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • Compassionate Cancer Care Medical Group

    Fountain Valley, California 92708
    United States

    Site Not Available

  • University of California Los Angeles (UCLA) Community Cancer Care

    Los Angeles, California 90095
    United States

    Site Not Available

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

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Site Not Available

  • Pontchartrain Cancer Center

    Covington, Louisiana 70433
    United States

    Site Not Available

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland 21231
    United States

    Site Not Available

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

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Gabrail Cancer Center

    Canton, Ohio 44718
    United States

    Site Not Available

  • VA Portland Health Care Services

    Portland, Oregon 97239
    United States

    Site Not Available

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Virginia Cancer Specalists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Site Not Available

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