Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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 criteria is confirmed. 6. Other exclusion criteria per protocol.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
INBRX-109
IV every three weeks
  • Drug: INBRX-109
    Tetravalent DR5 Agonist Antibody
Placebo Comparator
Placebo
IV every three weeks
  • Drug: Placebo
    Placebo

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Kristen Finn
617-724-4257
kfinn5@partners.org

More Details

Status
Recruiting
Sponsor
Inhibrx, Inc.

Study Contact

Michelle Darling
858-500-7833
clinicaltrials@inhibrx.com

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.