drugset / Trial / NCT07160335

A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors

NCT07160335 ↗

Phase 1 Recruiting 174 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety, and immunogenicity of HLX17 vs. US-sourced Keytruda® in patients with resected non-small cell lung cancer (NSCLC) or melanoma (MEL), or renal cell carcinoma (RCC).

Timeline

Start
2025-09-26
Primary completion
2027-04-30
Completion
2028-03-27

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX17 Unknown 200 mg —
Comparator Pembrolizumab Monoclonal antibody 200 mg —