Study of INBRX-109 in Conventional Chondrosarcoma
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|ClinicalTrials.gov Identifier: NCT04950075|
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : March 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Conventional Chondrosarcoma||Drug: INBRX-109 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||201 participants|
|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)|
|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|
IV every three weeks
Tetravalent DR5 Agonist Antibody
Placebo Comparator: Placebo
IV every three weeks
- Progression-free survival per RECISTv1.1 comparing INBRX-109 and placebo [ Time Frame: 3 years ]Progression-free survival per RECISTv1.1 will be determined.
- Overall survival of patients comparing INBRX-109 and placebo [ Time Frame: 3 years ]Overall survival will be determined.
- 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.
- 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.
- 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.
- Immunogenicity of INBRX-109 [ Time Frame: 3 years ]Frequency of anti-drug antibodies against INBRX-109 will be determined.
- Area under the curve of INBRX-109 [ Time Frame: 3 years ]The area under the curve of INBRX-109 will be determined.
- Peak serum concentration (Cmax) of INBRX-109 [ Time Frame: 3 years ]The peak serum concentration (Cmax) of INBRX-109 will be determined.
- Trough serum concentration (Ctrough) of INBRX-109 [ Time Frame: 3 years ]The trough serum concentration (Ctrough) of INBRX-109 will be determined.
- Time to maximum concentration (Tmax) of INBRX-109 [ Time Frame: 3 years ]The time to maximum concentration (Tmax) of INBRX-109 will be determined.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- 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.
- 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 criteria is confirmed.
- Other exclusion criteria per protocol.
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
|Contact: Michelle Darlingfirstname.lastname@example.org|
|Contact: Kevin Bayeremail@example.com|
|Study Director:||Vasily Andrianov, MD||Inhibrx, Inc.|
|Responsible Party:||Inhibrx, Inc.|
|Other Study ID Numbers:||
Ph2 INBRX-109 SA CS
|First Posted:||July 6, 2021 Key Record Dates|
|Last Update Posted:||March 10, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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