Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of INBRX-109 in Conventional Chondrosarcoma

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 : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Inhibrx, Inc.

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).

Layout table for study information
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 : February 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


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




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 will be determined.

  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. 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.

  4. Incidence and grades of treatment-emergent adverse events including serious adverse events [ 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.

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

  6. Area under the curve of INBRX-109 [ Time Frame: 3 years ]
    The area under the curve of INBRX-109 will be determined.

  7. Peak serum concentration (Cmax) of INBRX-109 [ Time Frame: 3 years ]
    The peak serum concentration (Cmax) of INBRX-109 will be determined.

  8. Trough serum concentration (Ctrough) of INBRX-109 [ Time Frame: 3 years ]
    The trough serum concentration (Ctrough) of INBRX-109 will be determined.

  9. Time to maximum concentration (Tmax) of INBRX-109 [ Time Frame: 3 years ]
    The time to maximum concentration (Tmax) of INBRX-109 will be determined.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (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 criteria is confirmed.
  6. Other exclusion criteria per protocol.

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
Layout table for location contacts
Contact: Michelle Darling (919) 667-3242 michelle@inhibrx.com
Contact: Miranda Fox miranda@inhibrx.com

Locations
Layout table for location information
United States, California
Sarcoma Oncology Center Recruiting
Santa Monica, California, United States, 90403
Contact: Victoria Chua-Alcala    310-552-9999    vchua@sarcomaoncology.com   
Principal Investigator: Sant P Chawla, MD         
Sponsors and Collaborators
Inhibrx, Inc.
Investigators
Layout table for investigator information
Study Director: Klaus Wagner, MD PhD Inhibrx, Inc.
Layout table for additonal information
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: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Chondrosarcoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma