A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

PI: Dr.ssa Silvia Stacchiotti 

This is a phase 2 clinical trial which aims to evaluate the efficacy and safety of a new treatment in a population of adult patients diagnosed with conventional chondrosarcoma in advanced stages of the disease, thus not amenable for surgery or radiation therapy; with evidence of progressive disease, and who have not previously received other systemic therapies for chondrosarcoma. In particular, this is a study that evaluates the activity of the drug INBRX-109, a drug belonging to the family of monoclonal antibodies, which targets the protein DR5 (Death Receptor 5), also known as TRAIL-R2, a protein relevant in the growth of chondrosarcoma. This study is a randomized, blinded and placebo-controlled study, which means that participants will be randomly assigned to receive the experimental drug, INBRX-109, or a placebo (a substance with no active effect), without patients or doctors knowing which treatment they are receiving. The main goal is to understand whether INBRX-109 can slow the progression of the disease and improve the quality of life compared to those who receive only the placebo. Participants will be carefully followed with regular check-ups to evaluate the effectiveness of the treatment and monitor any side effects. If there is evidence of disease progression, the study doctor will be able to verify whether the patient was receiving the active treatment or the placebo, and in this last case it will be possible to switch to the active drug (cross-over).