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A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies

Solid Tumor, Adult Clinical Trial

Official title:
A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies

Clinical Trial Summary

This study is a first-in-human (FIH) study which is required to understand the PK characteristics, MTD, and safety profile of NOV1601(CHC2014) in subjects with solid organ malignancies.

Clinical Trial Description

This is the first-in-human, Phase 1, open-label, multicenter, dose-escalation study to investigate the safety, tolerability, PK, and clinical activity of NOV1601(CHC2014) in subjects with solid organ malignancies. The primary goal of the study is to determine the RP2D of NOV1601(CHC2014) in adult subjects with solid organ malignancies. Dose escalation will follow a 3+3 design and will be based on prior cohort review. There will be 2 branches of the dosing schedule, once a day(QD) and twice daily(BID). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04014257
Study type Interventional
Source Handok Inc.
Contact
Status Completed
Phase Phase 1
Start date August 9, 2019
Completion date January 29, 2021
View Details
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