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Study of INBRX-109 (ozekibart) compared to placebo in adults with unresectable or metastatic chondrosarcoma - a rare bone cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with conventional chondrosarcoma, a type of bone and joint cancer that cannot be surgically removed (unresectable) or has spread to other parts of the body (metastatic). The main treatment being tested is INBRX-109 (also known as ozekibart), which is given through an intravenous infusion. The study will compare this medication to a placebo to determine if it is effective in treating this type of cancer.

The study aims to evaluate how well INBRX-109 works in preventing cancer progression compared to placebo. Participants will receive either INBRX-109 or placebo through an intravenous infusion. Additional medications that may be given during treatment include glucose solution, acetylcysteine, dexamethasone, and diphenhydramine to manage potential side effects of the treatment.

During the study, patients will receive treatment for up to 150 days. The treatment involves regular intravenous infusions of either INBRX-109 or placebo. Doctors will monitor patients' health status and perform regular imaging tests to check how the cancer responds to treatment. The study will track how long patients live without their cancer getting worse and measure overall survival.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial eligibility assessment

    Your doctor will verify if you meet the following main requirements:

    - Age between 18 and 85 years

    - Diagnosed with conventional chondrosarcoma (a type of bone and joint cancer) that cannot be surgically removed or has spread

    - Cancer growth confirmed by imaging tests in the last 6 months

    - Good overall physical condition with an ECOG score of 0 or 1 (able to perform daily activities)

    - Life expectancy of at least 12 weeks

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either:

    - INBRX-109 medication

    - Placebo (inactive substance)

  3. Step 3

    Treatment administration

    The medication will be given through:

    - Intravenous infusion (directly into your vein)

    - Some additional medications may be given orally or by injection

    Treatment will continue until June 2025 unless stopped earlier

  4. Step 4

    Monitoring and evaluation

    Regular assessments will include:

    - Imaging scans to measure tumor response

    - Blood tests to check your health status

    - Quality of life questionnaires focusing on pain and physical function

    - Monitoring for any side effects or health changes

  5. Step 5

    Study completion

    The study will end when:

    - The planned end date (June 2025) is reached

    - Your cancer shows progression

    - You experience unacceptable side effects

    - You choose to stop participating

Who can join the trial?

8 criteria

  • Age between 18 and 85 years old, both men and women can participate
  • Must have conventional chondrosarcoma that is either: - Unable to be surgically removed (unresectable), or - Has spread to other parts of the body (metastatic)
  • Must provide either stored tumor tissue samples or agree to a fresh tumor biopsy
  • Must have tumors that can be measured using special imaging techniques (RECIST criteria)
  • Must show evidence that the disease has gotten worse on scans within 6 months before starting the study treatment
  • Must have adequate: - Blood cell counts - Blood clotting function - Liver function - Kidney function
  • Must have good physical functioning ability (ECOG score of 0 or 1), with possible exceptions for patients with limited mobility due to previous cancer surgery
  • Must have a life expectancy of at least 12 weeks as determined by the doctor

Who cannot join the trial?

12 criteria

  • Prior treatment with death receptor 5 (DR5) targeted therapy (a specific type of cancer treatment)
  • History of central nervous system metastases (cancer spread to brain or spinal cord) unless treated and stable for at least 4 weeks
  • Active autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • Known infection with HIV, hepatitis B, or active hepatitis C
  • Major surgery within 4 weeks before starting the study treatment
  • History of other cancers within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Serious heart conditions including uncontrolled high blood pressure or recent heart attack
  • Severe liver dysfunction (problems with liver function)
  • Pregnant or breastfeeding women
  • Known allergies to the study medication or its components
  • Participation in another clinical trial within 4 weeks before starting this study
  • Any condition that, in the opinion of the investigator, would interfere with the safe conduct of the study
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Investigated drugs

INBRX-109 is an experimental medication being studied for treating chondrosarcoma, a type of bone cancer that has either spread to other parts of the body or cannot be surgically removed. This medication is designed to target and fight cancer cells. It's being compared to a placebo to determine how effective it is at slowing down or stopping the progression of the disease.

What is already known about the treatment

INBRX-109 - An investigational therapeutic agent currently being studied in clinical trials for the treatment of unresectable or metastatic conventional chondrosarcoma, a rare type of bone cancer. The medication is being evaluated in a Phase 2 randomized, blinded, placebo-controlled study to assess its effectiveness in preventing cancer progression. While the exact mechanism of action is still under investigation in clinical trials, the drug is being tested for its anticancer properties, with progression-free survival as the main measure of effectiveness. The trial compares INBRX-109 against placebo to determine its potential benefits for patients with this specific type of bone cancer.

Investigated diseases

Chondrosarcoma - A rare type of bone cancer that develops in cartilage cells. The disease begins when abnormal cartilage cells start growing and dividing, forming a tumor that can develop anywhere in the body where cartilage is present. When described as unresectable, it means the tumor cannot be completely removed through surgery, while metastatic indicates the cancer has spread to other parts of the body from its original location. This cancer most commonly affects the bones of the pelvis, upper leg, and upper arm, though it can occur in any bone. The conventional type is the most common form of chondrosarcoma, developing as a primary bone tumor.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517528-20-00Protocol codePh2 INBRX-109 SA CSEstimated enrolment201 patientsSponsorInhibrx Biosciences Inc.

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