Clinical Trial

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

Recruiting Phase 1
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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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-29; most recent amendment 2026-05-14.
Status change: Not Yet Recruiting → Recruiting 2025-11-14
Trial Details
NCT Number NCT07160335
Lead Sponsor Shanghai Henlius Biotech
Conditions Non-small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma
Enrollment 174 participants
Start Date 2025-09-26
Primary Completion 2027-04-30 (estimated)
Study Completion 2028-03-27 (estimated)
Updated on ClinicalTrials.gov 2026-05-15