Study of INBRX-109 in Conventional Chondrosarcoma
- Conditions
- Conventional Chondrosarcoma
- Registration Number
- NCT04950075
- Lead Sponsor
- Inhibrx Biosciences, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.<br><br> 2. Measurable disease by RECISTv1.1. Note: Tumor lesions located in a previously<br> irradiated (or other locally treated) area will be considered measurable, provided<br> there has been clear imaging-based progression of the lesions since the time of<br> treatment.<br><br> 3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to<br> screening for this study.<br><br> 4. Adequate hematologic, coagulation, hepatic and renal function as defined per<br> protocol.<br><br> 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.<br><br> 6. Estimated life expectancy of at least 12 weeks.<br><br> 7. Availability of archival tissue or fresh cancer biopsy are mandatory.<br><br>Exclusion Criteria:<br><br> 1. Any prior exposure to DR5 agonists.<br><br> 2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.<br><br> 3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal<br> myxoid, myxoid, and dedifferentiated chondrosarcoma.<br><br> 4. Prior or concurrent malignancies. Exception: Patients with a prior or concurrent<br> malignancy whose natural history or treatment does not have the potential to<br> interfere with the safety or efficacy assessments.<br><br> 5. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable<br> as long as adequate hepatic function as defined in the inclusion/exclusion criteria<br> is confirmed.<br><br> 6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.<br><br> 7. Other exclusion criteria per protocol.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival per RECISTv1.1 comparing INBRX-109 and placebo
- Secondary Outcome Measures
Name Time Method Overall survival of patients comparing INBRX-109 and placebo;Overall response rate (in percent), duration of response (in time) and disease control rate (in percent);PFS per RECISTv1.1 by Investigator assessment;Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo;DCR per RECISTv1.1 by real-time IRR;DOR per RECISTv1.1 by real-time IRR;To evaluate the safety and tolerability of INBRX-109;Characterize the pharmacokinetics of INBRX-109.;Immunogenicity of INBRX-109