NCT07362940

A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib

A Phase Ⅰ/Ⅱa Clinical Study Evaluating the Efficacy and Safety of GEN-725 in Combination With Dositinib in Patients With Locally Advanced or Metastatic EGFR-Mutant Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 110 (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, and preliminary efficacy of GEN-725 in combination with Dositinib in participants with locally advanced or metastatic EGFR-mutant non-small cell lung cancer.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	GEN-725 tablets + Dositinib mesylate tablets	Dose-escalation part (Phase Ⅰ): Subjects will receive once-daily oral administration of GEN-725 tablets in combination with Dositinib mesylate tablets on an empty stomach. GEN-725 will be administered at a dose of 6 mg or 9 mg, and Dositinib will be administered at a dose of 80 mg or 160 mg. Both drugs should be taken concurrently. The treatment will continue until the first occurrence of any of the following: disease progression, unacceptable toxicity, withdrawal of consent, or investigator's determination of no further clinical benefit. Dose-expansion part (Phase Ⅱa): Subjects will receive once-daily oral administration of GEN-725 tablets in combination with Dositinib mesylate tablets or Dositinib mesylate tablets alone on an empty stomach. The dose will be selected based on the outcome of dose-escalation phase. The treatment will continue until the first occurrence of any criterion that was specified in the dose-escalation part.

Timeline

• Start date: 2025-11-27
• Primary completion: 2027-07-31
• Completion: 2028-12-31
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

5 sites across 1 country: China