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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03715933
Other study ID # Ph1 INBRX-109
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 10, 2018
Est. completion date July 2026

Study information

Verified date April 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

This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).


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Study Design


Intervention

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Sponsors (1)

Lead Sponsor Collaborator
Inhibrx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Anti-tumor activity of INBRX-109 Tumor response will be determined by RECISTv1.1. Up to 2 years
Primary Frequency and severity of adverse events 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. Up to 2 years
Primary Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-109 The MTD and/or RP2D of INBRX-109 will be determined. Up to 2 years
Secondary Area under the serum concentration time curve (AUC) of INBRX-109 Area under the serum concentration time curve (AUC) of INBRX-109 will be determined. Up to 2 years
Secondary Immunogenicity of INBRX-109 Frequency of ant-drug antibodies (ADA) against INBRX-109 will be determined. Up to 2 years
Secondary Maximum observed serum concentration (Cmax) of INBRX-109 Maximum observed serum concentration (Cmax) of INBRX-109 will be determined. Up to 2 years
Secondary Trough observed serum concentration (Ctrough) of INBRX-109 Trough observed serum concentration (Cmax) of INBRX-109 will be determined. Up to 2 years
Secondary Time to Cmax (Tmax) of INBRX-109 Time to Cmax (Tmax) of INBRX-109 will be determined. Up to 2 years
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