Trial Title:
A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
NCT ID:
NCT05551117
Condition:
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
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Prostatic Neoplasms
Melanoma
Carcinoma, Squamous Cell
Small Cell Lung Carcinoma
Squamous Cell Carcinoma of Head and Neck
Anus Neoplasms
Carcinoma, Small Cell
Prostatic Neoplasms, Castration-Resistant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
vobramitamab duocarmazine 2.0 mg (Arm A)
Description:
2.0 mg/kg intravenous (IV) every 4 weeks
Arm group label:
Part 1: MGC018 2.0 mg (Arm A)
Other name:
MGC018
Intervention type:
Biological
Intervention name:
vobramitamab duocarmazine 2.7 mg (Arm B)
Description:
2.7 mg.kg IV every 4 weeks
Arm group label:
Part 1: MGC018 2.7 mg (Arm B)
Other name:
MGC018
Intervention type:
Biological
Intervention name:
vobramitamab duocarmazine
Description:
2.7 mg.kg IV every 4 weeks
Arm group label:
Part 2: Anal cancer cohort
Arm group label:
Part 2: HNSCC cohort
Arm group label:
Part 2: Melanoma cohort
Arm group label:
Part 2: SCLC cohort
Arm group label:
Part 2: Squamous NSCLC cohort
Other name:
MGC018
Intervention type:
Drug
Intervention name:
Abiraterone
Description:
1000 mg once daily
Arm group label:
Part 1: Control Arm
Intervention type:
Drug
Intervention name:
Enzalutamide
Description:
160 mg daily
Arm group label:
Part 1: Control Arm
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 squamous
cell carcinoma (SCC) of the anus, melanoma, head and neck squamous cell carcinoma
(HNSCC), squamous non-small cell lung carcinoma (NSCLC), and small cell lung carcinoma
(SCLC). Participants must have progressive following at least 1 prior line of standard
chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab
docarmazine 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Compassionate Cancer Care Medical Group
Address:
City:
Fountain Valley
Zip:
92708
Country:
United States
Facility:
Name:
University of California Los Angeles (UCLA) Community Cancer Care
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Facility:
Name:
The University of Florida Health System - UF Health Urology - Jacksonville
Address:
City:
Jacksonville
Zip:
32209
Country:
United States
Facility:
Name:
Mid Florida Hematology and Oncology Center
Address:
City:
Orange City
Zip:
32763
Country:
United States
Facility:
Name:
Pontchartrain Cancer Center
Address:
City:
Covington
Zip:
70433
Country:
United States
Facility:
Name:
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Facility:
Name:
Barbara Ann Karmanos Cancer Institute - Hudson-Webber Cancer Research Center
Address:
City:
Detroit
Zip:
48201
Country:
United States
Facility:
Name:
Masonic Cancer Center, University of Minnesota
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Facility:
Name:
Gabrail Cancer Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Facility:
Name:
VA Portland Health Care Services
Address:
City:
Portland
Zip:
97239
Country:
United States
Facility:
Name:
Carolina Urologic Research Center
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Facility:
Name:
University of Virginia Comprehensive Cancer Center
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Facility:
Name:
Virginia Cancer Specalists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Facility:
Name:
Ramsay Health Care - Westmead Private Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Facility:
Name:
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Facility:
Name:
Cabrini Health- Malvern
Address:
City:
Malvern
Zip:
3144
Country:
Australia
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Woluwe-Saint-Lambert
Zip:
1200
Country:
Belgium
Facility:
Name:
(Grand Hopital de Charleroi) GHDC
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Facility:
Name:
Centre Hospitalier de Ardenne - Libramont - Clinique du Sein
Address:
City:
Libramont
Zip:
6800
Country:
Belgium
Facility:
Name:
Centre Hospitalier Universitaire (CHU) - Universite Catholique de Louvain (UCL) - Namur - Site Godinne (Cliniques Universitaires UCL de Mont-Godinne)
Address:
City:
Godinne
Zip:
5300
Country:
Belgium
Facility:
Name:
Algemeen Ziekenhuis Maria Middelares
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Facility:
Name:
Centre Antoine-Lacassagne
Address:
City:
Nice Cedex 2
Zip:
06189
Country:
France
Facility:
Name:
Institut de Cancerologie Strasbourg Europe (ICANS)
Address:
City:
Strasbourg
Zip:
67200
Country:
France
Facility:
Name:
Institut Bergonié
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Facility:
Name:
Institut régional du Cancer de Montpellier - ICM Val d'Aurelle
Address:
City:
Montpellier
Zip:
34298
Country:
France
Facility:
Name:
Hôpital d'Instruction des Armées Bégin
Address:
City:
Saint-Mandé
Zip:
94160
Country:
France
Facility:
Name:
Hopital Foch
Address:
City:
Suresnes
Zip:
92150
Country:
France
Facility:
Name:
Centre Hospitalier Privé Saint-Grégoire
Address:
City:
Saint-Grégoire
Zip:
35760
Country:
France
Facility:
Name:
Clinique Victor Hugo
Address:
City:
Le Mans
Zip:
72000
Country:
France
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Facility:
Name:
CHRU Brest
Address:
City:
Brest
Zip:
29200
Country:
France
Facility:
Name:
Institut Mutualiste Montsouris
Address:
City:
Paris
Zip:
75014
Country:
France
Facility:
Name:
AOU San Luigi Gonzaga Oncology Department
Address:
City:
Orbassano
Zip:
10049
Country:
Italy
Facility:
Name:
Ospedale dell'Angelo
Address:
City:
Mestre
Zip:
30174
Country:
Italy
Facility:
Name:
Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence
Address:
City:
Florence
Zip:
50134
Country:
Italy
Facility:
Name:
Istituto Oncologico Veneto
Address:
City:
Padova
Zip:
35128
Country:
Italy
Facility:
Name:
Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara
Address:
City:
Trento
Zip:
38122
Country:
Italy
Facility:
Name:
Kyungpook National University Chilgok Hospital
Address:
City:
Bugok
Zip:
41404
Country:
Korea, Republic of
Facility:
Name:
National Cancer Center
Address:
City:
Goyang
Zip:
10408
Country:
Korea, Republic of
Facility:
Name:
Chonnam National University Hospital
Address:
City:
Gwangju
Zip:
61469
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hopital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Yonsei University Health System, Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Samsung Meical Cemter
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Facility:
Name:
Ewha Womans University Mokdong Hospital
Address:
City:
Seoul
Zip:
07985
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
5505
Country:
Korea, Republic of
Facility:
Name:
Szpital im. Fryderyka Chopina
Address:
City:
Otwock
Zip:
05-400
Country:
Poland
Facility:
Name:
Magodent Szpital Elblaska
Address:
City:
Warszawa
Zip:
01-748
Country:
Poland
Facility:
Name:
Medical Concierge Centrum Medyczne
Address:
City:
Warszawa
Zip:
02-798
Country:
Poland
Facility:
Name:
Grochowski Hospital
Address:
City:
Warszawa
Zip:
04-073
Country:
Poland
Facility:
Name:
Przychodnia Lekarska "KOMED"
Address:
City:
Konin
Zip:
62-500
Country:
Poland
Facility:
Name:
Szpital Wojewodzki im. Mikolaja Kopernika
Address:
City:
Koszalin
Zip:
75-581
Country:
Poland
Facility:
Name:
Hospital Universitari Parc Taulí
Address:
City:
Sabadell
Zip:
08208
Country:
Spain
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Facility:
Name:
Hospital Del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Facility:
Name:
Hospital de la Santa Creu I Sant Pau
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Facility:
Name:
Hospital Universitario Lucus Augusti
Address:
City:
Lugo
Zip:
27002
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
The Royal Marsden NHS Trust
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Facility:
Name:
Oxford University Hospitals NHS- Churchill Hospital
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Start date:
June 13, 2023
Completion date:
February 2025
Lead sponsor:
Agency:
MacroGenics
Agency class:
Industry
Source:
MacroGenics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05551117
