Ph2 INBRX-109 (Unresectable or Metastatic Conventional Chondrosarcoma)

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called INBRX-109 (the study drug) is a safe and effective option for people with unresectable or metastatic conventional chondrosarcoma.

What is the Condition Being Studied?

Unresectable or Metastatic Conventional Chondrosarcoma

Who Can Participate in the Study?

Adults ages 18+ who are diagnosed with unresectable or metastatic conventional chondrosarcoma.

For more information on who can participate in this study, please contact the study team at stephanie.weaver@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, during the screening period you will:

  • Have a tumor biopsy (unless a previous tumor tissue sample is available)
  • Have blood draws
  • Have imaging scans (CT or MRI)
  • Have an electrocardiogram (ECG) to check your heart function

If you are eligible for the study drug period, you will:

  • Get a random assignment to receive either the study drug or placebo (inactive substance) by intravenous (IV) infusion
  • Take a dose of 600-1200 mg of N-acetylcysteine and get a prescription for 8 mg dexamethasone
  • Have clinical visits for full physical examination and procedures including urine and blood sample collection
  • Have imaging scans (CT and MRI)
  • Have phone calls with the study team
  • Study Details

    Full Title
    A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
    Principal Investigator
    Associate Professor in Medicine
    Protocol Number
    IRB: PRO00108836
    NCT: NCT04950075
    Phase
    Phase II
    ClinicalTrials.gov
    Enrollment Status
    OPEN TO ACCRUAL