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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04950075




Registration number
NCT04950075
Ethics application status
Date submitted
14/06/2021
Date registered
6/07/2021

Titles & IDs
Public title
Study of INBRX-109 in Conventional Chondrosarcoma
Scientific title
A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
Secondary ID [1] 0 0
Ph2 INBRX-109 SA CS
Universal Trial Number (UTN)
Trial acronym
ChonDRAgon
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Conventional Chondrosarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INBRX-109
Treatment: Drugs - Placebo

Experimental: INBRX-109 - IV every three weeks

Placebo comparator: Placebo - IV every three weeks


Treatment: Drugs: INBRX-109
Tetravalent DR5 Agonist Antibody

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival per RECISTv1.1 comparing INBRX-109 and placebo
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Overall survival of patients comparing INBRX-109 and placebo
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Overall response rate (in percent), duration of response (in time) and disease control rate (in percent)
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
PFS per RECISTv1.1 by Investigator assessment
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
DCR per RECISTv1.1 by real-time IRR
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
DOR per RECISTv1.1 by real-time IRR
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
To evaluate the safety and tolerability of INBRX-109
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
Characterize the pharmacokinetics of INBRX-109.
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
Immunogenicity of INBRX-109
Timepoint [9] 0 0
3 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
201
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Iowa
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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Nebraska
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New Hampshire
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New York
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North Carolina
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Ohio
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Oklahoma
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United States of America
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Oregon
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United States of America
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Pennsylvania
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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France
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Cedex
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France
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Lyon
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France
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Marseille
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France
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Villejuif
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Germany
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Berlin
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Germany
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Mannheim
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Ireland
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Dublin
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Italy
State/province [30] 0 0
Bologna
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Italy
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Candiolo
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Italy
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Milano
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Italy
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Prato
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Italy
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Roma
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Netherlands
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Groningen
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Netherlands
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Leiden
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Inhibrx Biosciences, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Lead
Address 0 0
Inhibrx Biosciences, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director, -Inhibrx
Address 0 0
Country 0 0
Phone 0 0
858-500-7833
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04950075