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Clinical Trial 21105

Cancer Type: Sarcoma
Study Type: Treatment
NCT#: NCT04950075

Phase: Phase II
Principal Investigator: Brohl, Andrew

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Overview

Study Title

A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of INBRX-109 as Any-line Therapy in Conventional Chondrosarcoma

Summary

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).

Objective

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.

Treatments

Therapies

Immunotherapy; Therapy (NOS)

Medications

INBRX-109 (); Placebo ()

Inclusion Criteria

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.
  • Other criteria may apply

  • Exclusion Criteria

    Exclusion Criteria:

  • Any prior exposure to DR5 agonists.
  • Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
  • Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
  • 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.
  • Other exclusions apply

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