NCT04686682

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Jacobio Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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

Conditions

• NSCLC
• SCLC
• CRPC
• ESCC
• Ovarian Carcinoma
• AML
• MF
• Malignant Tumor

Interventions

Type	Name	Description
DRUG	JAB-8263	Variable dose, orally Q2D with 28 days each cycle
DRUG	JAB-8263	RP2D dose, orally Q2D with 28 days each cycle

Timeline

• Start date: 2021-05-07
• Primary completion: 2028-01-01
• Completion: 2028-07-01
• First posted: 2020-12-29
• Last updated: 2026-01-09

Locations

1 site across 1 country: China