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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

NCT07231068 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-11-17

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, preliminary efficacy of Dositinib in participants of locally advanced or metastatic non-small cell lung cancer with positive EGFR mutation.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Henan Genuine Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Junling Li · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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
2022-10-31
Primary Completion
2027-12-31
Completion
2029-12-31

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 NCT07231068 on ClinicalTrials.gov