RecruitingPhase 1Phase 2NCT06903377
Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
A Multicenter, Open-label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Enrollment
50 participants
Start Date
May 23, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a multicenter Phase I/II study for patients with advanced non-small cell lung cancer who have failed PD-1/L1 therapy, aiming to evaluate the safety of ZG005 in combination with Gecacitinib in this population, as well as the preliminary efficacy of this combination regimen.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria3
- Fully understand this study and voluntarily sign the ICF.
- Age 18-75 years, no gender restriction.
- Patients with locally advanced or recurrent/metastatic squamous and/or non-squamous non-small cell lung cancer confirmed by histology/cytology, unsuitable for radical therapy.
Exclusion Criteria3
- Medical history, CT scan, or MRI indicates the presence of CNS metastases.
- Other malignancies within 5 years.
- Any other reason deeming the participant unsuitable for the study, as judged by the investigator.
Interventions
BIOLOGICALZG005 for Injection
intravenous infusion
DRUGGecacitinib Hydrochloride Tablets
Oral
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06903377
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