Ozekibart

Table of contents

• What is ozekibart?
• How does ozekibart work?
• Which conditions is ozekibart used or studied for?
• How is ozekibart given?
• What do the clinical trials show?
• What side effects are known?

What is ozekibart?

Ozekibart (also known as INBRX-109) is an investigational antibody being studied for the treatment of advanced cancers. It is not yet authorised as a medicine. The U.S. Food and Drug Administration (FDA) granted ozekibart orphan drug designation for the treatment of chondrosarcoma on 24 November 2021.^[3] Orphan designation is a status given to medicines intended to treat rare diseases. The sponsor of the designation is Inhibrx, Inc., based in La Jolla, California.^[3]

How does ozekibart work?

The available sources do not describe the mechanism of action of ozekibart in detail. As an investigational antibody, it is a protein-based substance designed to target specific molecules involved in cancer. The clinical trial records list ozekibart as an intravenous drug, but the precise molecular target is not stated in the data provided.

Which conditions is ozekibart used or studied for?

Ozekibart is not authorised for any condition. It is being studied in clinical trials for the following conditions:

• Unresectable or metastatic conventional chondrosarcoma — a rare cancer of the bones and joints that cannot be removed by surgery or has spread to other parts of the body.^[2]
• Advanced or metastatic solid tumors, including sarcomas — a broad group of cancers that have spread or cannot be cured by local treatments, including Ewing sarcoma and colorectal adenocarcinoma.^[1]

How is ozekibart given?

Ozekibart is given by intravenous use. In the Phase 2 chondrosarcoma trial, the dose is reported as 3 mg per kilogram of body weight.^[2] The Phase 1/2 trial does not specify a dose in the registry record.^[1] Other medicines listed in the trial records, such as dexamethasone, acetylcysteine, diphenhydramine and glucose, are given alongside ozekibart as supportive or comparison treatments.

What do the clinical trials show?

Two clinical trials of ozekibart are registered. Both are authorised, meaning they have received regulatory approval to proceed.

What conditions are being studied?

The Phase 2 trial (NCT04950075) is studying ozekibart in adults with unresectable or metastatic conventional chondrosarcoma, a rare cancer of the bones and joints.^[2] The Phase 1/2 trial (NCT03715933) is studying ozekibart in adults and adolescents with advanced or metastatic solid tumors, including Ewing sarcoma, colorectal adenocarcinoma and SDH-deficient solid tumors or gastrointestinal stromal tumors (GIST).^[1]

What phases and status do the trials have?

The chondrosarcoma trial is a Phase 2 study with 201 participants, comparing ozekibart with placebo.^[2] The solid tumor trial is a Phase 1/2 study with 270 participants, testing ozekibart in combination with distinct chemotherapies and targeted therapies.^[1] Both trials are interventional studies with the status "Authorised".

What are the trials measuring?

The Phase 2 chondrosarcoma trial measures progression-free survival (PFS), which is the length of time a person lives without the cancer getting worse, assessed by central independent radiology review using RECIST version 1.1 criteria.^[2] The Phase 1/2 trial measures treatment-emergent adverse events (TEAEs), including dose-limiting toxicities and serious adverse events, as well as clinical response measured by objective response rate (ORR) and duration of response (DOR) in colorectal adenocarcinoma and Ewing sarcoma.^[1]

Who can take part in these trials?

The Phase 2 trial is for adults with unresectable or metastatic conventional chondrosarcoma.^[2] The Phase 1/2 trial includes adults and adolescents with advanced or metastatic Ewing sarcoma and adults with colorectal adenocarcinoma or SDH-deficient solid tumors or GIST.^[1]

What side effects are known?

The available sources do not provide information on the side effects of ozekibart. The Phase 1/2 trial is measuring treatment-emergent adverse events, including dose-limiting toxicities and serious adverse events, as part of its safety assessment.^[1]