NCT03518554

A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors

A Phase 1, Multi-Center, Dose Escalation, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3068 in Adult Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Jacobio Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.

Conditions

• Non-small Cell Lung Cancer
• Head and Neck Cancer
• Esophageal Cancer
• Other Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	JAB-3068	JAB-3068 will be orally administered on a daily basis. Patients need to fast 2 hours before （6 hours for PK days) and 2 hours after each dosing.

Timeline

• Start date: 2018-04-23
• Primary completion: 2022-02-03
• Completion: 2022-02-03
• First posted: 2018-05-08
• Last updated: 2024-12-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study