Study of INBRX-109 in Conventional Chondrosarcoma
Study of INBRX-109 in Conventional Chondrosarcoma
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or
metastatic conventional chondrosarcoma patients.
metastatic conventional chondrosarcoma patients.
Sarcoma
Phase II
Adults
Mol. targeted/Immunotherapy/Biologics
INBRX-109,
Placebo
Davis, Elizabeth
International
Vanderbilt University
02-04-2022
Eligibility
18 Years
BOTH
NO
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Exclusion Criteria:
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.
