Brief Summary
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
Intervention / Treatment
- Drug: INBRX-109
- Drug: Placebo
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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening for this study.
- Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group performance status (ECOG PS) of 0 or 1.
- Estimated life expectancy of at least 12 weeks.
- Availability of archival tissuea group of cells that work together to perform a function or fresh cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs biopsyremoval of a section of tissue to analyse for cancer cells are mandatory.