A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
Who is this study for? Patients with unresectable or metastatic conventional chondrosarcoma
What treatments are being studied? INBRX-109
Status: Recruiting
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:
• Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
• Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously irradiated (or other locally treated) area will be considered measurable, provided there has been clear imaging-based progression of the lesions since the time of treatment.
• Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
• Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
• Estimated life expectancy of at least 12 weeks.
• Availability of archival tissue or fresh cancer biopsy are mandatory.
Locations
United States
Arizona
Mayo Clinic Cancer Center
Recruiting
Phoenix
California
University of California, San Francisco (UCSF)
Recruiting
San Francisco
Sarcoma Oncology Center
Recruiting
Santa Monica
Colorado
University of Colorado
Recruiting
Denver
Florida
Mayo Clinic - Jacksonville
Recruiting
Jacksonville
Moffitt Cancer Center
Recruiting
Tampa
Iowa
University of Iowa
Not yet recruiting
Iowa City
Illinois
Rush Cancer Center
Recruiting
Chicago
Massachusetts
Dana Farber Cancer Institute
Recruiting
Boston
Massachusetts General Hospital
Recruiting
Boston
Maryland
Johns Hopkins
Recruiting
Baltimore
Michigan
University of Michigan
Recruiting
Ann Arbor
Minnesota
University of Minnesota
Not yet recruiting
Minneapolis
Missouri
Washington University School of Medicine - St. Louis
Recruiting
Saint Louis
North Carolina
Duke University
Not yet recruiting
Durham
Nebraska
Nebraska Methodist Hospital
Recruiting
Omaha
New Hampshire
Norris Cotton Cancer Center
Recruiting
Lebanon
New York
Columbia University
Recruiting
New York
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Ohio
Cleveland Clinic
Recruiting
Cleveland
Oklahoma
Oklahoma State University (OSU) - Stephenson Cancer Center
Recruiting
Oklahoma City
Oregon
Oregon Health & Science University (OHSU) Knight Cancer Institute
Recruiting
Portland
Pennsylvania
Thomas Jefferson University Hospital
Recruiting
Philadelphia
University of Pennsylvania
Not yet recruiting
Philadelphia
University of Pittsburgh Medical Center
Recruiting
Pittsburgh
Tennessee
Vanderbilt University Medical Center
Recruiting
Nashville
Texas
University of Texas Southwestern
Recruiting
Dallas
MD Anderson Cancer Center
Recruiting
Houston
Virginia
Virginia Cancer Specialists
Recruiting
Fairfax
Washington
Washington University - Seattle
Not yet recruiting
Seattle
Other Locations
France
Centre Leon Berard
Recruiting
Lyon
AP-HM - Hôpital de la Timone
Not yet recruiting
Marseille
Gustave Roussy
Recruiting
Villejuif
Germany
Helios Klinikum Berlin-Buch
Not yet recruiting
Berlin
Universitätsmedizin Mannheim
Recruiting
Mannheim
Ireland
Saint Vincent's University Hospital part of Irish Sarcoma Group
Recruiting
Dublin
Italy
Fondazione del Piemonte per I'Oncologia - Istituto di Candiolo IRCC
Recruiting
Candiolo
Fondazione IRCCS Istituto Nazionale dei Tumori
Recruiting
Milano
Nuovo Ospedale di Prato
Recruiting
Prato
Policlinico Universitario Campus Biomedico
Not yet recruiting
Roma
Netherlands
Groningen UMC
Recruiting
Groningen
Leiden University Medical Center
Recruiting
Leiden
Spain
Hospital de la Santa Creu i Sant Pau Barcelona
Recruiting
Barcelona
Hospital Universitario Vall d'Hebron
Recruiting
Barcelona
Hospital Clinico San Carlos
Recruiting
Madrid
Hospital Fundación Jiménez Díaz
Recruiting
Madrid
Hospital Universitari i Politecnic La Fe
Recruiting
Valencia
United Kingdom
Royal Marsden NHS Foundation Trust
Recruiting
London
University College London (UCL) - Medical School
Recruiting
London
The Christie NHS Foundation Trust
Not yet recruiting
Manchester
Churchill Hospital
Recruiting
Oxford
Contact Information
Primary
Michelle Darling
clinicaltrials@inhibrx.com
858-500-7833
Backup
Kevin Bayer
clinicaltrials@inhibrx.com
Time Frame
Start Date: September 23, 2021
Estimated Completion Date: June 2024
Participants
Target number of participants: 201
Treatments
Experimental: INBRX-109
IV every three weeks
Placebo Comparator: Placebo
IV every three weeks
Authors
Andrew Brohl, Ciara Kelly, Marta Batus, Lara Davis, Matthew Ingham, Rashmi Chugh, Melissa Burgess, Mahesh Seetharam, Kirsten Leu, Christian Meyer, Garrett Wasp, Jade Homsi, Atrayee Basu-Mallick, Alexander Spira, Anthony Conley, Dale Shepard, Breelyn Wilky, Andrew Wagner, Sant P Chawla, Brian Van Tine, Gregory Cote, Axel Le Cesne, Peter Hohenberger, Sarah Pratap, Sandra Strauss, Robin Jones, Antonio Casado, Mark Doherty, Roberto Diaz Beveridge, Andre (Hans) Gelderbloom, Giacomo Baldi, Ana Sebio Garcia, Giovanni Grignani, Victoria Wang, Claudia Valverde, Javier Martin-Broto, Silvia Stacchiotti, Jean-Yves Blay, Jacco de Haan, Steven Attia, Elizabeth Davis, Minh Phan
Related Therapeutic Areas
Sponsors
Leads: Inhibrx, Inc.