Ph2 INBRX-109 (Unresectable or Metastatic Conventional Chondrosarcoma)

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.

Who Can Participate?

Eligibility

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.

What is Involved?

Description

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

    Juneko
    Grilley Olson

    Protocol Number

    PRO00108836

    NCT ID

    NCT04950075

    Phase

    II

    Enrollment Status

    Open to Enrollment
    ClinicalTrials.gov