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:<ul>
<li>Have a tumor biopsy (unless a previous tumor tissue sample is available)</li>
<li>Have blood draws</li>
<li>Have imaging scans (CT or MRI)</li>
<li>Have an electrocardiogram (ECG) to check your heart function</li></ul>
If you are eligible for the study drug period, you will:
<li>Get a random assignment to receive either the study drug or placebo (inactive substance) by intravenous (IV) infusion</li>
<li>Take a dose of 600-1200 mg of N-acetylcysteine and get a prescription for 8 mg dexamethasone</li>
<li>Have clinical visits for full physical examination and procedures including urine and blood sample collection</li>
<li>Have imaging scans (CT and MRI)</li>
<li>Have phone calls with the study team</li></ul>
<li>Have a tumor biopsy (unless a previous tumor tissue sample is available)</li>
<li>Have blood draws</li>
<li>Have imaging scans (CT or MRI)</li>
<li>Have an electrocardiogram (ECG) to check your heart function</li></ul>
If you are eligible for the study drug period, you will:
<li>Get a random assignment to receive either the study drug or placebo (inactive substance) by intravenous (IV) infusion</li>
<li>Take a dose of 600-1200 mg of N-acetylcysteine and get a prescription for 8 mg dexamethasone</li>
<li>Have clinical visits for full physical examination and procedures including urine and blood sample collection</li>
<li>Have imaging scans (CT and MRI)</li>
<li>Have phone calls with the study team</li></ul>
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