NCT07231068

A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutation

A Dose-escalation and Dose-expansion Phase I/Phase II Clinical Study on the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Dositinib Mesylate Tablets (90-1408) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With Positive EGFR Mutations

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Henan Genuine Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open label phase I/phase II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, preliminary efficacy of Dositinib in participants of locally advanced or metastatic non-small cell lung cancer with positive EGFR mutation.

Detailed description

Dositinib is an EGFR-TKI. There are two parts in the study. Phase I is dose escalation study, and Phase II is dose expansion study. Phase I will be conducted using 3+3 dose escalation method. In Phase II, 3 dose levels will be chosen to further evaluate the safety and efficacy of Dositinib.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Dositinib mesylate tablets	Dose-escalation part: Subjects received 90-1408 at doses of 20, 40, 80, 160, 200 and 240 mg. A single oral dose was administered on Cycle 1 Day 1, then once daily from Day 8 onward. Dosing occurred in the morning, with 21 days of continuous treatment per cycle. Dose-expansion part: Subjects received 90-1408 orally at a dose of 80, 160 and 200 mg, administered once daily for 21 consecutive days per cycle.

Timeline

• Start date: 2022-10-31
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2025-11-17
• Last updated: 2025-11-17

Locations

5 sites across 1 country: China