Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
206
Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo
Progression-free survival per RECISTv1.1 will be determined.
Time frame: 3 years
Overall survival of patients comparing INBRX-109 and placebo
Overall Survival in the ITT population
Time frame: 3 years
ORR per RECISTv1.1 by real-time IRR.
Tumor response will be determined by RECISTv1.1.
Time frame: 3 years
PFS per RECISTv1.1 by Investigator assessment
PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.
Time frame: 3 years
Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo
Quality of life will be determined.
Time frame: 3 years
DCR per RECISTv1.1 by real-time IRR
measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
Time frame: 3 years
DOR per RECISTv1.1 by real-time IRR
evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo
Time frame: 3 years
To evaluate the safety and tolerability of INBRX-109
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mayo Clinic Cancer Center
Phoenix, Arizona, United States
Precision NextGen Oncology & Research Center
Beverly Hills, California, 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
Yale Cancer Center
New Haven, Connecticut, 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
...and 58 more locations
Time frame: 3 years
Characterize the pharmacokinetics of INBRX-109.
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.
Time frame: 3 years
Immunogenicity of INBRX-109
Frequency of anti-drug antibodies against INBRX-109 will be determined.
Time frame: 3 years