Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

Details

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).

Keywords

Conventional Chondrosarcoma DR5 INBRX-109 Apoptosis Programmed cell death Chondrosarcoma

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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 criteria is confirmed.
  6. Other exclusion criteria per protocol.

Locations

  • University of California, San Francisco (UCSF) not yet accepting patients
    San Francisco California 94110 United States
  • Sarcoma Oncology Center accepting new patients
    Santa Monica California 90403 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Inhibrx, Inc.
ID
NCT04950075
Phase
Phase 2
Study Type
Interventional
Last Updated