Study of INBRX-109 in Conventional Chondrosarcoma (NCT04950075) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of INBRX-109 in Conventional Chondrosarcoma
United States, Australia, France206 participantsStarted 2021-09-23
Plain-language summary
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
. Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously irradiated (or other locally treated) area will be considered measurable, provided there has been clear imaging-based progression of the lesions since the time of treatment.
. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
. Estimated life expectancy of at least 12 weeks.
. Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion criteria
. Any prior exposure to DR5 agonists.
. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo
. Prior or concurrent malignancies. Exception: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments.
. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.