Clinical trial NCT04950075: Study of INBRX-109 in Conventional Chondrosarcoma
Official title: A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Conventional Chondrosarcoma
Keywords: DR5
INBRX-109
Apoptosis
Programmed cell death
Lead sponsor: Inhibrx Biosciences, Inc
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: INBRX-109 and placebo arms are in parallel. Patients on placebo are allowed to cross-over to open-label INBRX-109 at time of disease progression.
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
2. 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.
3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
6. Estimated life expectancy of at least 12 weeks.
7. Availability of archival tissue or fresh cancer biopsy are mandatory.

Exclusion Criteria:

1. Any prior exposure to DR5 agonists.
2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
4. 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.
5. 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.
6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
7. Other exclusion criteria per protocol.

Primary outcomes:
measure: Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival of patients comparing INBRX-109 and placebo
timeFrame: 3 years
measure: ORR per RECISTv1.1 by real-time IRR.
timeFrame: 3 years
measure: PFS per RECISTv1.1 by Investigator assessment
timeFrame: 3 years
measure: Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo
timeFrame: 3 years
measure: DCR per RECISTv1.1 by real-time IRR
timeFrame: 3 years
measure: DOR per RECISTv1.1 by real-time IRR
timeFrame: 3 years
measure: To evaluate the safety and tolerability of INBRX-109
timeFrame: 3 years
measure: Characterize the pharmacokinetics of INBRX-109.
timeFrame: 3 years
measure: Immunogenicity of INBRX-109
timeFrame: 3 years
Other outcomes:
measure: Evaluate Quality of Life
timeFrame: 3 years
measure: Potential predictive response biomarkers
timeFrame: 3 years
measure: PFS per RECISTv1.1 by Investigator assessment
timeFrame: 3 years
measure: ORR per RECISTv1.1 by Investigator assessment
timeFrame: 3 years
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Cancer Center
state: Arizona
city: Beverly Hills
country: United States
facility: Precision NextGen Oncology & Research Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University - Robert H. Lurie Comprehensive Cancer Center
state: Illinois
city: Chicago
country: United States
facility: Rush Cancer Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine - St. Louis
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma - Stephenson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU) Knight Cancer Institute
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Bordeaux
country: France
facility: Institut Bergonie
state: Cedex
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: AP-HM - Hôpital de la Timone
city: Villejuif
country: France
facility: Gustave Roussy
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Dublin
country: Ireland
facility: Saint Vincent's University Hospital part of Irish Sarcoma Group
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli di Bologna
city: Candiolo
country: Italy
facility: La Fondazione e l'Istituto di Candiolo
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico
city: Groningen
country: Netherlands
facility: Groningen UMC
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau Barcelona
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: London
country: United Kingdom
facility: University College London Hospital (UCL)
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Inhibrx Biosciences, Inc
name: Clinical Lead
role: STUDY_DIRECTOR
References: