MedTrace Logo

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

NCT07362940 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-23

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Henan Genuine Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-27
Primary Completion
2027-07-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07362940 on ClinicalTrials.gov