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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04950075
Other study ID # Ph2 INBRX-109 SA CS
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 23, 2021
Est. completion date June 2025

Study information

Verified date May 2024
Source Inhibrx, Inc.
Contact Study Director, -Inhibrx
Phone 858-500-7833
Email clinicaltrials@inhibrx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
INBRX-109
Tetravalent DR5 Agonist Antibody
Placebo
Placebo

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Sponsors (1)

Lead Sponsor Collaborator
Inhibrx, Inc.

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Ireland,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Evaluate Quality of Life QoL per EORTC QLQ-C30, EQ-5D-5L, PGI-C, PGI-S 3 years
Other Potential predictive response biomarkers Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109 3 years
Other PFS per RECISTv1.1 by Investigator assessment evaluate the anticancer efficacy of INBRX-109 as measured by PFS (by Investigator assessment) for crossover population after treatment with INBRX-109 3 years
Other ORR per RECISTv1.1 by Investigator assessment evaluate the anticancer efficacy of INBRX-109 as measured by ORR (by Investigator assessment) for crossover population after treatment with INBRX-109 3 years
Primary Progression-free survival per RECISTv1.1 comparing INBRX-109 and placebo Progression-free survival per RECISTv1.1 will be determined. 3 years
Secondary Overall survival of patients comparing INBRX-109 and placebo Overall Survival in the ITT population 3 years
Secondary Overall response rate (in percent), duration of response (in time) and disease control rate (in percent) Tumor response will be determined by RECISTv1.1. 3 years
Secondary PFS per RECISTv1.1 by Investigator assessment PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo. 3 years
Secondary Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo Quality of life will be determined. 3 years
Secondary DCR per RECISTv1.1 by real-time IRR measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo 3 years
Secondary DOR per RECISTv1.1 by real-time IRR evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo 3 years
Secondary To evaluate the safety and tolerability of INBRX-109 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. 3 years
Secondary Characterize the pharmacokinetics of INBRX-109. 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 (?z, t1/2, Vd, CL, and accumulation ratios RCmax, RCtrough) 3 years
Secondary Immunogenicity of INBRX-109 Frequency of anti-drug antibodies against INBRX-109 will be determined. 3 years
See also
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Completed NCT01310816 - A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma Phase 2