NCT04587479

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Jacobio Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Solid Tumors, Adult

Interventions

Type	Name	Description
DRUG	JAB-8263	Variable dose, orally Q2D with 28 days each cycle

Timeline

• Start date: 2020-11-23
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2020-10-14
• Last updated: 2026-01-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study