Study of INBRX-109 in Conventional Chondrosarcoma

Sponsor: Inhibrx Biosciences, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04950075

Patient View

This Phase 2 study evaluates INBRX-109, a tetravalent DR5 agonist antibody, versus placebo in patients with unresectable or metastatic conventional chondrosarcoma. Eligible participants must have measurable disease, recent radiologic progression, adequate organ function, ECOG PS 0-1, and a life expectancy of at least 12 weeks. Archival tissue or fresh biopsy is required.

Patient Parameters

Program Overview

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

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).

Eligibility Criteria

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/exclusion criteria is confirmed.
  6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
  7. Other exclusion criteria per protocol.

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