US-sourced Keytruda®

DRUG3 trials

Sponsors

mAbxience Research S.L., Shanghai Henlius Biotech

Conditions

MelanomaNon Squamous Non Small Cell Lung CancerNon-Squamous Non-Small Cell Lung CancerNon-small Cell Lung CancerRenal Cell Carcinoma

Phase 1

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

Active, not recruitingNCT07160335

Shanghai Henlius BiotechMelanoma, Non-small Cell Lung Cancer, Renal Cell Carcinoma

Start: 2025-09-26End: 2028-03-27Target: 174Updated: 2026-08-18

Phase 3

A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)

Active, not recruitingNCT06687369

mAbxience Research S.L.Non Squamous Non Small Cell Lung Cancer

Start: 2024-12-30End: 2027-09-01Target: 726Updated: 2026-09-10

A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

Not yet recruitingNCT06847334

Shanghai Henlius BiotechNon-Squamous Non-Small Cell Lung Cancer

Start: 2025-04-27End: 2028-01-24Target: 772Updated: 2025-02-26