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