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Clinical Trial Summary

This is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors


Clinical Trial Description

This study is a Phase 1, open-label, multicenter study of NB004 administered orally in patients with histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are metastatic for which all standard treatment options have been given and are ineffective, or is no longer eligible for additional standard treatment options. The study is comprised of a dose escalation phase to determine the maximum tolerated dose and the RP2D and an expansion phase to further explore the safety and preliminary antitumor activity of NB004. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05036291
Study type Interventional
Source Ningbo Newbay Technology Development Co., Ltd
Contact Yanhua Xu
Phone +8613916714882
Email TMF-ISF@newbaypharma.com
Status Recruiting
Phase Phase 1
Start date October 1, 2021
Completion date June 1, 2025

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