Conventional ChondrosarcomaPhase 2ChonDRAgonNCT04950075
Study of INBRX-109 in Conventional Chondrosarcoma
A Phase 2 study testing INBRX-109 in people with Conventional Chondrosarcoma, run by Inhibrx Biosciences, Inc at 68 sites in 9 countries.
Trial summary
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Conventional Chondrosarcoma
- What is being tested?
- INBRX-109
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 68 sitesin 9 countries
- Study dates
- 23 Sep 2021to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
- Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
- Other exclusion criteria per protocol.
Trial locations and contacts
68 sites in 9 countries.
68 sites in 9 countries
United States32 sites
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins
Baltimore, Maryland, 21287
Precision NextGen Oncology & Research Center
Beverly Hills, California, 90212
Dana Farber Cancer Institute
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University - Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
Rush Cancer Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern
Dallas, Texas, 75390
University of Colorado
Denver, Colorado, 80220
Duke University
Durham, North Carolina, 27710
Virginia Cancer Specialists
Fairfax, Virginia, 22031
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03766
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale Cancer Center
New Haven, Connecticut, 06519
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Columbia University
New York, New York, 10032
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Mayo Clinic Cancer Center
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Oregon Health & Science University (OHSU) Knight Cancer Institute
Portland, Oregon, 97201
Mayo Clinic Rochester
Rochester, Minnesota, 99505
University of California, San Francisco (UCSF)
San Francisco, California, 94110
Sarcoma Oncology Center
Santa Monica, California, 90403
University of Washington
Seattle, Washington, 98109
Washington University School of Medicine - St. Louis
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612
France9 sites
Institut Bergonie
Bordeaux, Cedex, 33076
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 69373
AP-HM - Hôpital de la Timone
Marseille, 13005
ICM - Institut Regional du Cancer de Montpellier
Montpellier
Centre Antoine-Lacassagne
Nice
AP-HP Hopital Cochin
Paris
Centre Eugene Marquis
Rennes
Gustave Roussy
Villejuif, 94805
Spain7 sites
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, 08041
Hospital Clinico San Carlos
Madrid, 28040
Hospital Fundación Jiménez Díaz
Madrid, 28040
Hospital Clinico Universitario de Santiago
Santiago de Compostela
Hospital Universitario Virgen del Rocio
Seville
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Italy6 sites
IRCCS Istituto Ortopedico Rizzoli di Bologna
Bologna, 40136
La Fondazione e l'Istituto di Candiolo
Candiolo, 10060
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127
Nuovo Ospedale di Prato
Prato, 59100
Policlinico Universitario Campus Biomedico
Roma, 00128
Germany4 sites
Helios Klinikum Berlin-Buch
Berlin, 13125
Universitaetsklinikum Heidelberg
Heidelberg
Universitätsmedizin Mannheim
Mannheim, 68167
Universitaetsklinikum Tuebingen
Tübingen
United Kingdom4 sites
University College London Hospital (UCL)
London, NW1 2PG
Royal Marsden NHS Foundation Trust
London, SW3 6JJ
The Christie NHS Foundation Trust
Manchester, M20 4BX
Churchill Hospital
Oxford, OX3 7LJ
Australia3 sites
Royal Adelaide Hospital
Adelaide, 5000
Chris O'Brien Lifehouse
Camperdown, 2050
Princess Alexandra Hospital
Woolloongabba
Netherlands2 sites
Groningen UMC
Groningen, 9713 GZ
Leiden University Medical Center
Leiden, 2333 ZA
Ireland1 site
Saint Vincent's University Hospital part of Irish Sarcoma Group
Dublin, D04 T6F4
About this study
Official title: 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.
Read the 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).
- Conditions
- Conventional Chondrosarcoma
- Being tested
- INBRX-109, Placebo
- Keywords
- DR5, INBRX-109, Apoptosis, Programmed cell death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INBRX-109Drug
Tetravalent DR5 Agonist Antibody
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| INBRX-109 | Experimental | IV every three weeks Receives: Drug: INBRX-109 |
| Placebo | Placebo comparator | IV every three weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo
Progression-free survival per RECISTv1.1 will be determined.
Measured: 3 years
Secondary outcomes (9)
Overall survival of patients comparing INBRX-109 and placebo
Overall Survival in the ITT population
Measured: 3 years
ORR per RECISTv1.1 by real-time IRR.
Tumor response will be determined by RECISTv1.1.
Measured: 3 years
PFS per RECISTv1.1 by Investigator assessment
PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.
Measured: 3 years
Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo
Quality of life will be determined.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 3 years
Immunogenicity of INBRX-109
Frequency of anti-drug antibodies against INBRX-109 will be determined.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start23 Sep 2021
- Primary completion30 Sep 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conventional ChondrosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inhibrx Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Lead, Study director, Inhibrx Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950075
- Sponsor's protocol ID
- Ph2 INBRX-109 SA CS
- Acronym
- ChonDRAgon
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2021
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
- ClinicalTrials.gov ID
- NCT04950075
- Acronym / sponsor ID
- ChonDRAgon / Ph2 INBRX-109 SA CS
- Conditions
- Conventional Chondrosarcoma
- Keywords
- DR5, INBRX-109, Apoptosis, Programmed cell death
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Inhibrx Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| INBRX-109 | Experimental | Drug: INBRX-109IV every three weeks |
| Placebo | Placebo comparator | Drug: PlaceboIV every three weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INBRX-109Tetravalent DR5 Agonist Antibody | Drug | INBRX-109 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo
Time frame: 3 years
Progression-free survival per RECISTv1.1 will be determined.
9 secondary outcomes
Overall survival of patients comparing INBRX-109 and placebo
Time frame: 3 years
ORR per RECISTv1.1 by real-time IRR.
Time frame: 3 years
PFS per RECISTv1.1 by Investigator assessment
Time frame: 3 years
Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo
Time frame: 3 years
DCR per RECISTv1.1 by real-time IRR
Time frame: 3 years
DOR per RECISTv1.1 by real-time IRR
Time frame: 3 years
To evaluate the safety and tolerability of INBRX-109
Time frame: 3 years
Characterize the pharmacokinetics of INBRX-109.
Time frame: 3 years
Immunogenicity of INBRX-109
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Conventional Chondrosarcoma
RecruitingPhase 3
Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen
Active, not recruitingPhase 2
Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma
Locally Advanced Unresectable Primary Central Chondrosarcoma, Metastatic Primary Central Chondrosarcoma
Not yet recruitingObservational study
Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
Osteosarcoma, Bone Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Lead study director
Inhibrx Biosciences, Inc
68 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INBRX-109 in people with Conventional Chondrosarcoma, run by Inhibrx Biosciences, Inc at 68 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, France, Spain, Italy, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.