ACTIVE_NOT_RECRUITING

Study of INBRX-109 in Conventional Chondrosarcoma

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Conditions

Conventional ChondrosarcomaDR5INBRX-109ApoptosisProgrammed cell death

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-09-23
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04950075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Conventional chondrosarcoma, unresectable (=inoperable) or metastatic.
  2. 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. 3. Radiologic progression of disease per RECISTv1.1 criteria within 6 months prior to screening for this study.
  4. 4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
  5. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  6. 6. Estimated life expectancy of at least 12 weeks.
  7. 7. Availability of archival tissue or fresh cancer biopsy are mandatory.
  1. 1. Any prior exposure to DR5 agonists.
  2. 2. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
  3. 3. Non-conventional chondrosarcoma, e.g., clear-cell, mesenchymal, extraskeletal myxoid, myxoid, and dedifferentiated chondrosarcoma.
  4. 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. 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. 6. Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
  7. 7. Other exclusion criteria per protocol.

Contacts and Locations

Principal Investigator

Clinical Lead
STUDY_DIRECTOR
Inhibrx Biosciences, Inc

Study Locations (Sites)

Mayo Clinic Cancer Center
Phoenix, Arizona, 85054
United States
Precision NextGen Oncology & Research Center
Beverly Hills, California, 90212
United States
University of California, San Francisco (UCSF)
San Francisco, California, 94110
United States
Sarcoma Oncology Center
Santa Monica, California, 90403
United States
University of Colorado
Denver, Colorado, 80220
United States
Yale Cancer Center
New Haven, Connecticut, 06519
United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
United States
Rush Cancer Center
Chicago, Illinois, 60612
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Johns Hopkins
Baltimore, Maryland, 21287
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02114
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Mayo Clinic Rochester
Rochester, Minnesota, 99505
United States
Washington University School of Medicine - St. Louis
St Louis, Missouri, 63110
United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03766
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
United States
Columbia University
New York, New York, 10032
United States
Duke University
Durham, North Carolina, 27710
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Health & Science University (OHSU) Knight Cancer Institute
Portland, Oregon, 97201
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
University of Texas Southwestern
Dallas, Texas, 75390
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
University of Washington
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Inhibrx Biosciences, Inc

  • Clinical Lead, STUDY_DIRECTOR, Inhibrx Biosciences, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-23
Study Completion Date2026-12

Study Record Updates

Study Start Date2021-09-23
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • DR5
  • INBRX-109
  • Apoptosis
  • Programmed cell death

Additional Relevant MeSH Terms

  • Conventional Chondrosarcoma