Study of INBRX-109 in Conventional Chondrosarcoma (ChonDRAgon)
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|ClinicalTrials.gov Identifier: NCT04950075|
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : May 15, 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 in the ITT population
- 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.
- PFS per RECISTv1.1 by Investigator assessment [ Time Frame: 3 years ]PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo.
- 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.
- 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
- 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
- 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.
- 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)
- Immunogenicity of INBRX-109 [ Time Frame: 3 years ]Frequency of anti-drug antibodies against INBRX-109 will be determined.
- Evaluate Quality of Life [ Time Frame: 3 years ]QoL per EORTC QLQ-C30, EQ-5D-5L, PGI-C, PGI-S
- Potential predictive response biomarkers [ Time Frame: 3 years ]Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109
- 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
- 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
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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|
- 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/exclusion criteria is confirmed.
- Evidence or history of multiple sclerosis (MS) or other demyelinating disorders.
- 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 Darlingemail@example.com|
|Contact: Kevin Bayerfirstname.lastname@example.org|
|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:||May 15, 2023|
|Last Verified:||May 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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