Conventional Chondrosarcoma
Conditions
Keywords
DR5, INBRX-109, Apoptosis, Programmed cell death
Brief summary
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
Detailed description
This is a randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. INBRX-109 is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
Interventions
DRUGINBRX-109
Tetravalent DR5 Agonist Antibody
DRUGPlacebo
Placebo
Sponsors
Inhibrx Biosciences, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
INBRX-109 and placebo arms are in parallel. Patients on placebo are allowed to cross-over to open-label INBRX-109 at time of disease progression.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic. 2. 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. 3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study. 4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. Estimated life expectancy of at least 12 weeks. 7. Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion criteria
1. Any prior exposure to DR5 agonists. 2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies. 3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma. 4. 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. 5. Chronic liver diseases. Exception: Patients with fatty liver disease are acceptable as long as adequate hepatic function as defined in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo | 3 years | Progression-free survival per RECISTv1.1 will be determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival of patients comparing INBRX-109 and placebo | 3 years | Overall Survival in the ITT population |
| ORR per RECISTv1.1 by real-time IRR. | 3 years | Tumor response will be determined by RECISTv1.1. |
| PFS per RECISTv1.1 by Investigator assessment | 3 years | PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo. |
| Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo | 3 years | Quality of life will be determined. |
| DCR per RECISTv1.1 by real-time IRR | 3 years | measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo |
| DOR per RECISTv1.1 by real-time IRR | 3 years | evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo |
| To evaluate the safety and tolerability of INBRX-109 | 3 years | Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. |
| Characterize the pharmacokinetics of INBRX-109. | 3 years | AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non-compartmental method as the data allow. Other PK parameters (λz, t½, Vd, CL, and accumulation ratios RCmax, RCtrough) will be calculated if data permit. |
| Immunogenicity of INBRX-109 | 3 years | Frequency of anti-drug antibodies against INBRX-109 will be determined. |
Countries
Australia, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Lead
Inhibrx Biosciences, Inc
Outcome results
None listed