Study of INBRX-109 in Conventional Chondrosarcoma (ChonDRAgon)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Conventional Chondrosarcoma
• Intervention / Treatment: Drug: Placebo; Drug: INBRX-109

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).

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Royal Adelaide Hospital
  • Camperdown, Australia, 2050
    • Chris O'Brien Lifehouse
  • Woolloongabba, Australia
    • Princess Alexandra Hospital
• France
  • Lille, France, 59020
    • Centre Oscar Lambret
  • Lyon, France, 69373
    • Centre Léon Bérard
  • Marseille, France, 13005
    • AP-HM - Hôpital de la Timone
  • Montpellier, France
    • ICM - Institut Regional du Cancer de Montpellier
  • Nice, France
    • Centre Antoine-Lacassagne
  • Paris, France
    • AP-HP Hôpital Cochin
  • Rennes, France
    • Centre Eugène Marquis
  • Villejuif, France, 94805
    • Gustave Roussy
  • Cedex
    • Bordeaux, Cedex, France, 33076
      • Institut Bergonie
• Germany
  • Berlin, Germany, 13125
    • Helios Klinikum Berlin-Buch
  • Heidelberg, Germany
    • Universitaetsklinikum Heidelberg
  • Mannheim, Germany, 68167
    • Universitätsmedizin Mannheim
  • Tübingen, Germany
    • Universitaetsklinikum Tuebingen
• Ireland
  • Dublin, Ireland, D04 T6F4
    • Saint Vincent's University Hospital part of Irish Sarcoma Group
• Italy
  • Bologna, Italy, 40136
    • IRCCS Istituto Ortopedico Rizzoli di Bologna
  • Candiolo, Italy, 10060
    • La Fondazione e l'Istituto di Candiolo
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Palermo, Italy, 90127
    • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  • Prato, Italy, 59100
    • Nuovo Ospedale di Prato
  • Roma, Italy, 00128
    • Policlinico Universitario Campus Biomedico
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Groningen UMC
  • Leiden, Netherlands, 2333 ZA
    • Leiden University Medical Center
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau Barcelona
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28040
    • Hospital Fundacion Jimenez Diaz
  • Santiago de Compostela, Spain
    • Hospital Clinico Universitario de Santiago
  • Seville, Spain
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46026
    • Hospital Universitari i Politècnic La Fe
• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden NHS Foundation Trust
  • London, United Kingdom, NW1 2PG
    • University College London Hospital (UCL)
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
  • Oxford, United Kingdom, OX3 7LJ
    • Churchill Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Cancer Center
  • California
    • Beverly Hills, California, United States, 90212
      • Precision NextGen Oncology & Research Center
    • San Francisco, California, United States, 94110
      • University of California, San Francisco (UCSF)
    • Santa Monica, California, United States, 90403
      • Sarcoma Oncology Center
  • Colorado
    • Denver, Colorado, United States, 80220
      • University of Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale Cancer Center
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Jacksonville
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University - Robert H. Lurie Comprehensive Cancer Center
    • Chicago, Illinois, United States, 60612
      • Rush Cancer Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02114
      • Dana Farber Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 99505
      • Mayo Clinic Rochester
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine - St. Louis
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Norris Cotton Cancer Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma - Stephenson Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97201
      • Oregon Health & Science University (OHSU) Knight Cancer Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INBRX-109; IV every three weeks	Drug: INBRX-109; Tetravalent DR5 Agonist Antibody
Placebo Comparator: Placebo; IV every three weeks	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo	Quality of life will be determined.	3 years
Immunogenicity of INBRX-109	Frequency of anti-drug antibodies against INBRX-109 will be determined.	3 years
Overall survival of patients comparing INBRX-109 and placebo	Overall Survival in the ITT population	3 years
PFS per RECISTv1.1 by Investigator assessment	PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.	3 years
DCR per RECISTv1.1 by real-time IRR	measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo	3 years
DOR per RECISTv1.1 by real-time IRR	evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo	3 years
To evaluate the safety and tolerability of INBRX-109	Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.	3 years
ORR per RECISTv1.1 by real-time IRR.	Tumor response will be determined by RECISTv1.1.	3 years
Characterize the pharmacokinetics of INBRX-109.	AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non-compartmental method as the data allow. Other PK parameters (λz, t½, Vd, CL, and accumulation ratios RCmax, RCtrough) will be calculated if data permit.	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Quality of Life	QoL per EORTC QLQ-C30, EQ-5D-5L, PGI-C, PGI-S	3 years
Potential predictive response biomarkers	Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109	3 years
PFS per RECISTv1.1 by Investigator assessment	evaluate the anticancer efficacy of INBRX-109 as measured by PFS (by Investigator assessment) for crossover population after treatment with INBRX-109	3 years
ORR per RECISTv1.1 by Investigator assessment	evaluate the anticancer efficacy of INBRX-109 as measured by ORR (by Investigator assessment) for crossover population after treatment with INBRX-109	3 years

Collaborators and Investigators

• Sponsor: Inhibrx Biosciences, Inc
• Investigators: Study Director: Clinical Lead, Inhibrx Biosciences, Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Actual): September 30, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Apoptosis; DR5; INBRX-109; Programmed cell death
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Chondrosarcoma
• Other Study ID Numbers: Ph2 INBRX-109 SA CS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No