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A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors

NSCLC Clinical Trial

Official title:
A Phase I/IIa, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Patients With Advanced Malignant Tumors

Clinical Trial Summary

This is a Phase 1/2a, first-in-human, open-label study of JAB-8263, this study has two parts: solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study. These two parts will determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately. 30 subjects each 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 malignant 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 NCT04686682
Study type Interventional
Source Jacobio Pharmaceuticals Co., Ltd.
Contact Jacobio Pharmaceuticals
Phone 86 10 56315466
Email clinicaltrials@jacobiopharma.com
Status Recruiting
Phase Phase 1/Phase 2
Start date May 7, 2021
Completion date September 2024
View Details
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