A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of INBRX-109 as Any-line Therapy in Conventional Chondrosarcoma
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).
1. To evaluate the anticancer efficacy of INBRX-109 in the intention-to-treat (ITT) population as measured by progression free survival (PFS) per RECISTv1.1, assessed by central independent radiology review (IRR), comparing INBRX-109 and placebo;
2. To evaluate the anticancer efficacy of INBRX-109 as measured by overall survival (OS) comparing INBRX-109 and placebo;
3. To evaluate the anticancer efficacy of INBRX-109 as measured by objective response rate (ORR) per RECISTv1.1, assessed by central IRR, comparing INBRX-109 and placebo;
4. To evaluate duration of response (DOR) per RECISTv1.1, assessed by central IRR, comparing INBRX-109 and placebo;
5. To evaluate the anticancer efficacy of INBRX-109 as measured by disease control rate (DCR) per RECISTv1.1, assessed by central IRR, comparing INBRX-109 and placebo.
6. To evaluate the anticancer efficacy of INBRX-109 as measured by PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo;
7. To evaluate quality of life (QoL), comparing INBRX-109 and placebo (i.e., EORTC QLQ-C30);
8. To evaluate the safety and tolerability of INBRX-109;
9. To characterize the pharmacokinetics of INBRX-109;
10. To evaluate the frequency of anti-drug antibodies (ADA), and neutralizing ADA (NAb), against INBRX-109 and to explore the potential relationship with safety, pharmacokinetics and efficacy of INBRX-109.
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.
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 criteria is confirmed.
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