Clinical trial • Phase II • Oncology

OZEKIBART for Conventional chondrosarcoma

Phase II trial of OZEKIBART for Conventional chondrosarcoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Conventional chondrosarcoma
Trial Stage
Phase II
Drug Modality
Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
20-09-2024
First CTIS Authorization Date
21-10-2024

Trial design

Randomised, placebo: glucose (solution for infusion) administered as intravenous infusion (placebo control). Phase II trial across 31 sites in Germany, Spain, Italy and others.

Randomised
Yes
Comparator
Placebo: GLUCOSE (solution for infusion) administered as intravenous infusion (placebo control).
Target Sample Size
104
Trial Duration For Participant
150

Eligibility

Recruits 104 The trial record indicates 'isVulnerablePopulationSelected': true and contains subject information and informed consent forms for special situations (e.g. 'L1_SIS and ICF_PregnantPartner', 'L1_SIS and ICF_Data collection on child'). Country- and topic-specific ICF documents are available (pregnant partner ICF, data collection on child). The main consent approach uses L1 SIS and ICF documents; no explicit assent process for minors is described in the available metadata..

Vulnerable Population
The trial record indicates 'isVulnerablePopulationSelected': true and contains subject information and informed consent forms for special situations (e.g. 'L1_SIS and ICF_PregnantPartner', 'L1_SIS and ICF_Data collection on child'). Country- and topic-specific ICF documents are available (pregnant partner ICF, data collection on child). The main consent approach uses L1 SIS and ICF documents; no explicit assent process for minors is described in the available metadata.

Inclusion criteria

  • {"criterion_text":"- Males or females aged ≥ 18 to ≤ 85 years\n- Conventional (or primary) chondrosarcoma, unresectable (i.e., not amenable to tumor resection with curative intent) or metastatic. Availability of archival tissue or fresh cancer biopsy are mandatory.\n- 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.\n- Evidence of confirmed radiographic disease progression per RECISTv1.1 criteria within 6 months prior to start of study treatment.\n- Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.\n- ECOG PS of 0 or 1 (Exception: Inclusion of non-frail, physically active patients with compromised mobility due to prior cancer surgery (eg, limb amputation, hemipelvectomy) should be discussed with the Medical Monitor or Study Director)\n- Estimated life expectancy, in the documented judgment of the Investigator, of at least 12 weeks."}

Exclusion criteria

  • {"criterion_text":"- Any prior exposure to DR5 agonists.\n- Allergy or sensitivity to INBRX-109 or known allergies to Chinese hamster ovary (CHO) cell-produced antibodies, which in the opinion of the Investigator suggest an increased potential for an adverse hypersensitivity to INBRX-109.\n- Non-conventional CSs, eg, clear-cell, mesenchymal, extra-skeletal myxoid, myxoid, and dedifferentiated CS.\n- 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.\n- 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.\n- Any evidence or history of multiple sclerosis (MS) or other demyelinating disorders."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression Free Survival (PFS) per RECISTv1.1 assessed by central IRR in the ITT population","definition_or_measurement_approach":"PFS measured per RECIST v1.1 assessed by central real-time independent radiology review (IRR) in the Intention To Treat (ITT) population."}

Secondary endpoints

  • {"endpoint_text":"- Overall Survival (OS) in the ITT Population\n- ORR per RECISTv1.1 by central real-time IRR.\n- PFS per RECISTv1.1 by Investigator assessment.\n- QoL per EORTC QLQ-C30 (Pain and Physical Function).\n- DCR per RECISTv1.1 by central real-time IRR.\n- DOR per RECISTv1.1 by central real-time IRR.\n- Treatment emergent adverse events (TEAEs) including Serious adverse event (SAEs).\n- PK characterization: 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.\n- Frequency of ADAs and Nabs.","definition_or_measurement_approach":"OS: overall survival in ITT. ORR/DCR/DOR/PFS: per RECIST v1.1, with central real-time IRR for specified endpoints and Investigator assessment for one PFS endpoint. QoL: measured by EORTC QLQ-C30 (Pain and Physical Function scales). Safety: TEAEs and SAEs monitoring. PK: non-compartmental analysis estimating AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax; other PK parameters (λz, t½, Vd, CL, accumulation ratios) if data permit. Immunogenicity: frequency of ADAs and neutralizing antibodies (NAbs)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
104
Recruitment Window Months
58
Consent Approach
Informed consent obtained using L1 SIS and ICF subject information and consent documents; multiple country- and language-specific ICFs are available (English, French, Spanish, Dutch, Italian versions are listed). Additional ICFs for pregnant partners and pre-screening are provided. Consent is provided by adult participants (trial inclusion is ≥18 years). No explicit description of assent for minors is provided in the available materials.

Methods

  • HCP outreach (Dear Colleague letters, HCP Factsheet, HCP Flyer) — materials available (country-specific versions listed for Germany, Spain, Italy, Ireland, Netherlands, France).
  • Patient-facing materials (Patient Recruitment Leaflet / Patient Leaflet) — country-specific patient leaflets available.
  • Social media postings / Social Media Post — digital recruitment materials provided (country-specific social media documents available).
  • GP/Primary care engagement (GP Letter) — GP letter available (Ireland-specific L2 material).

Geography

Total Number Of Sites
31
Total Number Of Participants
97

Germany

Earliest CTIS Part Ii Submission Date
08-10-2024
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
500
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Sektion Spezielle chirurgische Onkologie und Thoraxchirurgie
Contact Person Name
Peter Hohenberger
Contact Person Email
Peter.Hohenberger@umm.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Innere Medizin VIII
Contact Person Name
Christoph Deinzer
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Klinik für Onkologie und Palliativmedizin
Contact Person Name
Peter Reichardt
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Medical Oncology
Contact Person Name
Richard Schlenk

Spain

Earliest CTIS Part Ii Submission Date
08-10-2024
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
507
Number Of Sites
8
Number Of Participants
27

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Claudia Valverde
Contact Person Email
cmvalver@vhebron.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Javier Martin-Broto
Contact Person Email
jmartin@atbsarc.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Irene Carrasco Garcia
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Ana Sebio Garcia
Contact Person Email
asebio@santpau.cat
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Antonio Casado
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Contact Person Name
Nieves Purificación Martinez Lago
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Roberto Diaz Beveridge
Contact Person Email
diaz_rob@gva.es
Site Name
Hospital Universitario Y Politecnico La Fe (additional entry)
Department Name
Oncology
Contact Person Name
Roberto Diaz Beveridge
Contact Person Email
diaz_rob@gva.es

Italy

Earliest CTIS Part Ii Submission Date
08-10-2024
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
504
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Oncologia
Contact Person Name
Giuseppe Badalamenti
Contact Person Email
giuseppe.badalamenti@unipa.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica
Contact Person Name
Silvia Stacchiotti
Site Name
Istituto Ortopedico Rizzoli
Department Name
Oncologia
Contact Person Name
Giorgio Frega
Contact Person Email
giorgio.frega@ior.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Oncologia
Contact Person Name
Sandra Aliberti
Contact Person Email
sandra.aliberti@ircc.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
Oncologia
Contact Person Name
Bruno Vincenzi

Ireland

Earliest CTIS Part Ii Submission Date
08-10-2024
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
538
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
St Vincent's University Hospital
Department Name
Oncology
Contact Person Name
Mark Doherty
Contact Person Email
markdoherty@svhg.ie

Netherlands

Earliest CTIS Part Ii Submission Date
08-10-2024
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
499
Number Of Sites
2
Number Of Participants
22

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Clinical Oncology
Contact Person Name
André Johan Gelderblom
Contact Person Email
a.j.gelderblom@lumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Medical Oncology
Contact Person Name
Jacco-Juri de Haan
Contact Person Email
j.j.de.haan@umcg.nl

France

Earliest CTIS Part Ii Submission Date
08-10-2024
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
499
Number Of Sites
11
Number Of Participants
15

Sites

Site Name
Institut Gustave Roussy
Department Name
Sarcoma
Contact Person Name
Axel Le Cesne
Contact Person Email
axel.lecesne@gustaveroussy.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Medical Oncology
Contact Person Name
Jean-Emmanuel Kurtz
Contact Person Email
je.kurtz@icans.eu
Site Name
Centre Antoine Lacassagne
Department Name
Medical oncology
Contact Person Name
Esma SAADA-BOUZID
Site Name
Oncopole Claudius Regaud
Department Name
Medical Oncology
Contact Person Name
Thibaud Valentin
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncology
Contact Person Name
Perrine Vuagnat
Contact Person Email
p.vuagnat@rennes.unicancer.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Nelly Firmin
Contact Person Email
nelly.firmin@icm.unicancer.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Jean-Yves Blay
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Medical Oncology
Contact Person Name
Florence Duffaud
Contact Person Email
florence.duffaud@ap-hm.fr
Site Name
Institut Bergonie
Department Name
Medical Oncology
Contact Person Name
Maud Toulmonde
Site Name
Centre Oscar Lambret
Department Name
Medical Oncology
Contact Person Name
Loïc Lebellec
Contact Person Email
l-lebellec@o-lambret.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Medical Oncology
Contact Person Name
Pascaline Boudou-Rouquette
Contact Person Email
pascaline.boudou@aphp.fr

Sponsor

Primary sponsor

Full Name
Inhibrx Biosciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Almac Clinical Technologies LLC
Responsibilities
sponsorDuties: code 3 (as listed)
Name
Parexel International (IRL) Limited
Responsibilities
sponsorDuties: code 8 (as listed)
Name
Medidata Solutions Inc.
Responsibilities
sponsorDuties: code 7 (as listed)
Name
Q Squared Solutions Limited / Q Squared Solutions Holdings LLC
Responsibilities
Kits for PK/ADA collect samples (sponsorDuties code 15)
Name
Median Technologies
Responsibilities
Central Independent Radiology Review (sponsorDuties code 15)
Name
Bioagilytix Labs LLC
Responsibilities
sponsorDuties: code 4 (as listed)
Name
Tempus Labs Inc.
Responsibilities
sponsorDuties: code 4 (as listed)

Third parties

  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties: [{\"id\":887037,\"code\":\"3\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"sponsorDuties: [{\"id\":887035,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Median Technologies","duties_or_roles":"Central Independent Radiology Review (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Kits for PK/ADA collect samples (sponsorDuties code 15)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties: [{\"id\":887034,\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties: [{\"id\":887033,\"code\":\"7\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"Kits for PK/ADA collect samples (sponsorDuties code 15)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Tempus Labs Inc.","duties_or_roles":"sponsorDuties: [{\"id\":887031,\"code\":\"4\"}]","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
INBRX-109 (Ozekibart)
Active Substance
OZEKIBART
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
No marketing authorisation (marketingAuthNumber: -)
Orphan Designation
Yes
Maximum Dose
150 mg/kg

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