NCT05514496

A Study of NX-019 in Patients with Advanced, Epidermal Growth Factor Receptor (EGFR) Mutant Cancer

A First-in-Human, Open-Label, Dose Escalation and Expansion Study of Orally Administered NX-019 in Patients with Advanced, EGFR Mutant Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: Nalo Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of NX-019 and preliminary efficacy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutant cancer.

Detailed description

Part 1: The primary objective of Part 1 of this study is to evaluate the safety and tolerability of NX-019 and to determine the maximum tolerated dose (MTD)/Recommended Expansion Dose(s) (REDs). Part 2: The primary objective of Part 2 of this study is to confirm the safety and tolerability of NX-019 at the REDs and, for each expansion cohort, the preliminary evidence of efficacy as measured by objective response rate (ORR).

Conditions

• EGFR Mutation-Related Tumors

Interventions

Type	Name	Description
DRUG	NX-019	NX-019 will be administered orally.

Timeline

• Start date: 2022-10-05
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2022-08-24
• Last updated: 2025-03-11

Locations

12 sites across 3 countries: United States, South Korea, Taiwan

Regulatory

• FDA-regulated drug study