Study of INBRX-109 in Conventional Chondrosarcoma
- Registration Number
- NCT04950075
- Lead Sponsor
- Inhibrx Biosciences, Inc
- Brief Summary
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
- Detailed Description
This is a randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. INBRX-109 is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 201
- 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.
- Any prior exposure to DR5 agonists.
- Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
- Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
- Prior or concurrent malignancies. Exception: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments.
- Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
- Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
- Other exclusion criteria per protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INBRX-109 INBRX-109 IV every three weeks Placebo Placebo IV every three weeks
- Primary Outcome Measures
Name Time Method Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo 3 years Progression-free survival per RECISTv1.1 will be determined.
- Secondary Outcome Measures
Name Time Method DOR per RECISTv1.1 by real-time IRR 3 years evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
To evaluate the safety and tolerability of INBRX-109 3 years Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Overall survival of patients comparing INBRX-109 and placebo 3 years Overall Survival in the ITT population
ORR per RECISTv1.1 by real-time IRR. 3 years Tumor response will be determined by RECISTv1.1.
PFS per RECISTv1.1 by Investigator assessment 3 years PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.
Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo 3 years Quality of life will be determined.
DCR per RECISTv1.1 by real-time IRR 3 years measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
Characterize the pharmacokinetics of INBRX-109. 3 years AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non-compartmental method as the data allow. Other PK parameters (λz, t½, Vd, CL, and accumulation ratios RCmax, RCtrough) will be calculated if data permit.
Immunogenicity of INBRX-109 3 years Frequency of anti-drug antibodies against INBRX-109 will be determined.
Trial Locations
- Locations (58)
Precision NextGen Oncology & Research Center
🇺🇸Beverly Hills, California, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
University of Oklahoma - Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Washington
🇺🇸Seattle, Washington, United States
Centre Oscar Lambret
🇫🇷Lille, France
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Mayo Clinic Cancer Center
🇺🇸Phoenix, Arizona, United States
University of California, San Francisco (UCSF)
🇺🇸San Francisco, California, United States
Sarcoma Oncology Center
🇺🇸Santa Monica, California, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
Rush Cancer Center
🇺🇸Chicago, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Washington University School of Medicine - St. Louis
🇺🇸Saint Louis, Missouri, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Columbia University
🇺🇸New York, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Oregon Health & Science University (OHSU) Knight Cancer Institute
🇺🇸Portland, Oregon, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Chris O'Brien Lifehouse
🇦🇺Camperdown, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia
Institut Bergonie
🇫🇷Bordeaux, Cedex, France
Centre Leon Berard
🇫🇷Lyon, France
AP-HM - Hôpital de la Timone
🇫🇷Marseille, France
Gustave Roussy
🇫🇷Villejuif, France
Helios Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Universitätsmedizin Mannheim
🇩🇪Mannheim, Germany
Saint Vincent's University Hospital part of Irish Sarcoma Group
🇮🇪Dublin, Ireland
IRCCS Istituto Ortopedico Rizzoli di Bologna
🇮🇹Bologna, Italy
La Fondazione e l'Istituto di Candiolo
🇮🇹Candiolo, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Nuovo Ospedale di Prato
🇮🇹Prato, Italy
Policlinico Universitario Campus Biomedico
🇮🇹Roma, Italy
Groningen UMC
🇳🇱Groningen, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau Barcelona
🇪🇸Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Fundación Jiménez DÃaz
🇪🇸Madrid, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
University College London Hospital (UCL)
🇬🇧London, United Kingdom
Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom