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
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Shanghai Chest Hospital
RECRUITING
Shanghai
Contact Information
Primary
Cong Zhang
zhangc@zelgen.com
17602176888
Time Frame
Start Date: 2025-05-23
Estimated Completion Date: 2027-05
Participants
Target number of participants: 50
Treatments
Experimental: Part1-Group A
ZG005 20mg/kg IV Q3W+Gecacitinib 50mg po Bid
Experimental: Part1-Group B
ZG005 20mg/kg Q3W+Gecacitinib 100mg po Bid
Related Therapeutic Areas
Sponsors
Leads: Suzhou Zelgen Biopharmaceuticals Co.,Ltd