NCT07160335

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

A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® (US-sourced Keytruda®) in Multiple Resected Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-small Cell Lung Cancer
• Melanoma
• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	HLX17	Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle
DRUG	US-sourced Keytruda®	Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle

Timeline

• Start date: 2025-09-26
• Primary completion: 2027-04-30
• Completion: 2028-03-27
• First posted: 2025-09-08
• Last updated: 2026-02-13

Locations

69 sites across 4 countries: United States, China, Georgia, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study