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Study of INBRX-109 in Conventional Chondrosarcoma (ChonDRAgon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04950075
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : May 9, 2024
Sponsor:
Information provided by (Responsible Party):
Inhibrx, Inc.

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

Condition or disease Intervention/treatment Phase
Conventional Chondrosarcoma Drug: INBRX-109 Drug: Placebo Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma
Actual Study Start Date : September 23, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival per RECISTv1.1 comparing INBRX-109 and placebo [ Time Frame: 3 years ]
    Progression-free survival per RECISTv1.1 will be determined.


Secondary Outcome Measures :
  1. Overall survival of patients comparing INBRX-109 and placebo [ Time Frame: 3 years ]
    Overall Survival in the ITT population

  2. Overall response rate (in percent), duration of response (in time) and disease control rate (in percent) [ Time Frame: 3 years ]
    Tumor response will be determined by RECISTv1.1.

  3. PFS per RECISTv1.1 by Investigator assessment [ Time Frame: 3 years ]
    PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.

  4. Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo [ Time Frame: 3 years ]
    Quality of life will be determined.

  5. DCR per RECISTv1.1 by real-time IRR [ Time Frame: 3 years ]
    measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo

  6. DOR per RECISTv1.1 by real-time IRR [ Time Frame: 3 years ]
    evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo

  7. To evaluate the safety and tolerability of INBRX-109 [ Time Frame: 3 years ]
    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.

  8. Characterize the pharmacokinetics of INBRX-109. [ Time Frame: 3 years ]
    AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non- Sponsor: Inhibrx, Inc. Version 5.0 (Amendment 4) Protocol Number: Ph2 INBRX-109 SA CS 28-Feb-2023 Page 41 of 113 CONFIDENTIAL Objective Endpoint compartmental method as the data allow. Other PK parameters (λz, t1/2, Vd, CL, and accumulation ratios RCmax, RCtrough)

  9. Immunogenicity of INBRX-109 [ Time Frame: 3 years ]
    Frequency of anti-drug antibodies against INBRX-109 will be determined.


Other Outcome Measures:
  1. Evaluate Quality of Life [ Time Frame: 3 years ]
    QoL per EORTC QLQ-C30, EQ-5D-5L, PGI-C, PGI-S

  2. Potential predictive response biomarkers [ Time Frame: 3 years ]
    Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109

  3. PFS per RECISTv1.1 by Investigator assessment [ Time Frame: 3 years ]
    evaluate the anticancer efficacy of INBRX-109 as measured by PFS (by Investigator assessment) for crossover population after treatment with INBRX-109

  4. ORR per RECISTv1.1 by Investigator assessment [ Time Frame: 3 years ]
    evaluate the anticancer efficacy of INBRX-109 as measured by ORR (by Investigator assessment) for crossover population after treatment with INBRX-109


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04950075


Contacts
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Contact: Study Director, -Inhibrx 858-500-7833 clinicaltrials@inhibrx.com

Locations
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Sponsors and Collaborators
Inhibrx, Inc.
Investigators
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Study Director: Clinical Lead Inhibrx, Inc.
More Information
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Responsible Party: Inhibrx, Inc.
ClinicalTrials.gov Identifier: NCT04950075    
Other Study ID Numbers: Ph2 INBRX-109 SA CS
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inhibrx, Inc.:
DR5
INBRX-109
Apoptosis
Programmed cell death
Additional relevant MeSH terms:
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Chondrosarcoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma