Phase 2 Study of INBRX-109 in Chondrosarcoma (Ph2 INBRX-109 SA CS)
Research type
Research Study
Full title
A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
IRAS ID
1003996
Contact name
Sam Morris
Contact email
Sponsor organisation
Inhibrx, Inc.
Eudract number
2021-002635-35
Clinicaltrials.gov Identifier
Research summary
Chondrosarcomas (CS) are a varied group of cancerous bone tumours and are the third most common type of primary (original) bone cancer after myeloma and osteosarcoma. CS can occur at any age but are more common in people older than 40 years of age and usually affects middle-aged to elderly adults. There are four types of CS and the ‘conventional’ type is the most common, representing 85%-90% of cases. Though most conventional CS is slow-growing and unlikely to spread, a small percentage (about 10%) of people have an aggressive type that spreads easily and results in a lower life expectancy.
Treatment for conventional CS which has not spread is usually surgery, and the best outcomes are achieved if the cancer is completely removed. There are currently no systemic therapies (e.g. chemotherapy) that have been approved for use for people with conventional CS where their cancer cannot be surgically removed or has already spread. The therapy being investigated in this study, INBRX-109, is a medication that has been designed to target cancerous cells and trigger their death whilst preserving normal cells.
This is a randomised, blinded, placebo-controlled, Phase 2 study investigating the efficacy (anti-cancer effectiveness) of INBRX-109. Information on the safety and tolerability of the medication will also be collected, as well as quality-of-life data from participant surveys. Participants will be randomised with a 2 to 1 chance of receiving INBRX-109 compared to placebo, but if their cancer progresses on placebo they can choose to start receiving INBRX-109. The study will recruit people aged 18 or over with conventional CS that cannot be surgically removed or has spread, provided they meet all the eligibility criteria in the Protocol.
The study will include a total of approximately 200 participants and is being carried out in clinics in North America and Europe. In the UK, the study will be run at NHS hospitals. The study is sponsored by Inhibrx, Inc.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0012
Date of REC Opinion
22 Feb 2022
REC opinion
Further Information Favourable Opinion