NCT06106152

WTX212A Monotherapy and in Combination With PD -1/PD-L1 Monoclonal Antibody

A Single-center, Open Label, Exploratory Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of WTX212A Injection Combined With PD -1/PD-L1 Monoclonal Antibody in Patients With Advanced Lung Cancer

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer

Detailed description

The trial consist of Screening Period (30 days), Treatment Period (21\*n days), Safety Follow-up Period (90 days) and Survival follow-up. About 20 subjects are planned to be enrolled in the study.

Conditions

• Advanced Lung Cancer

Interventions

Type	Name	Description
DRUG	WTX212A injection	The WTX212A infusion is given every 21 days
DRUG	PD -1/PD-L1 monoclonal antibody	The PD -1/PD-L1 monoclonal antibody is given every 21 days

Timeline

• Start date: 2023-12-05
• Primary completion: 2024-10-30
• Completion: 2025-12-31
• First posted: 2023-10-30
• Last updated: 2024-03-26

Locations

1 site across 1 country: China