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A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors

Solid Tumors, Adult Clinical Trial

Official title:
A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Subjects With Advanced Solid Tumors

Clinical Trial Summary

This is a Phase 1, first-in-human, open-label study of JAB-8263 to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT. 30 subjects with advanced solid tumor will be enrolled.

Clinical Trial Description

JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (BET) proteins. The objectives of this study are: To determine the maximum-tolerated dose (MTD) and assess the dose-limiting toxicity (DLT) of JAB-8263 as a single agent to adult subjects with advanced solid tumors To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic (PK) parameters and pharmacodynamics (PDc) To evaluate preliminary antitumor activity of JAB-8263 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04587479
Study type Interventional
Source Jacobio Pharmaceuticals Co., Ltd.
Contact Jacobio Pharmaceuticals
Phone 86 10 56315466
Email clinicaltrials@jacobiopharma.com
Status Recruiting
Phase Phase 1
Start date November 23, 2020
Completion date April 30, 2023
View Details
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