Study of INBRX-109 in Conventional Chondrosarcoma

NCT04950075 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Ph2 INBRX-109 SA CS
• Study Type: interventional
• Target: 206
• Locations: 9 countries
• Sites: 68

Brief Summary

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

Conditions

Conventional Chondrosarcoma

Keywords

DR5; INBRX-109; Apoptosis; Programmed cell death

Outcome Measures

Primary Outcomes (1)

• Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo

  Progression-free survival per RECISTv1.1 will be determined.

  3 years

Secondary Outcomes (9)

• Overall survival of patients comparing INBRX-109 and placebo

  3 years

• ORR per RECISTv1.1 by real-time IRR.

  3 years

• PFS per RECISTv1.1 by Investigator assessment

  3 years

• Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo

  3 years

• DCR per RECISTv1.1 by real-time IRR

  3 years

Other Outcomes (4)

• Evaluate Quality of Life

  3 years

• Potential predictive response biomarkers

  3 years

• PFS per RECISTv1.1 by Investigator assessment

  3 years

Study Arms (2)

INBRX-109

EXPERIMENTAL

IV every three weeks

Drug: INBRX-109

Placebo

PLACEBO COMPARATOR

IV every three weeks

Drug: Placebo

Interventions

INBRX-109 DRUG

Tetravalent DR5 Agonist Antibody

INBRX-109

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.

Sponsors & Collaborators

• Inhibrx Biosciences, Inc: lead

Study Sites (68)

Mayo Clinic Cancer Center

Phoenix, Arizona, 85054, United States

Location

Precision NextGen Oncology & Research Center

Beverly Hills, California, 90212, United States

Location

University of California, San Francisco (UCSF)

San Francisco, California, 94110, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

University of Colorado

Denver, Colorado, 80220, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06519, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern University - Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Location

Rush Cancer Center

Chicago, Illinois, 60612, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 99505, United States

Location

Washington University School of Medicine - St. Louis

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03766, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma - Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health & Science University (OHSU) Knight Cancer Institute

Portland, Oregon, 97201, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Chris O'Brien Lifehouse

Camperdown, 2050, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Australia

Location

Institut Bergonie

Bordeaux, Cedex, 33076, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

AP-HM - Hôpital de la Timone

Marseille, 13005, France

Location

ICM - Institut Regional du Cancer de Montpellier

Montpellier, France

Location

Centre Antoine-Lacassagne

Nice, France

Location

AP-HP Hopital Cochin

Paris, France

Location

Centre Eugene Marquis

Rennes, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Helios Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Location

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, Germany

Location

Saint Vincent's University Hospital part of Irish Sarcoma Group

Dublin, D04 T6F4, Ireland

Location

IRCCS Istituto Ortopedico Rizzoli di Bologna

Bologna, 40136, Italy

Location

La Fondazione e l'Istituto di Candiolo

Candiolo, 10060, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Nuovo Ospedale di Prato

Prato, 59100, Italy

Location

Policlinico Universitario Campus Biomedico

Roma, 00128, Italy

Location

Groningen UMC

Groningen, 9713 GZ, Netherlands

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau Barcelona

Barcelona, 08041, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

University College London Hospital (UCL)

London, NW1 2PG, United Kingdom

Location

Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Study Officials

• Clinical Lead

  Inhibrx Biosciences, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 6, 2021
• Study Start: September 23, 2021
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); GB (4); FR (9); ES (7); IT (6); AU (3); NL (2); US (32); DE (4)