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 Interventional Study
Non-small Cell Lung Cancer Melanoma Renal Cell Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
174 (estimated)
Sponsor
Shanghai Henlius Biotech · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participants must have signed and dated an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines. 2. At least 18 years and no older than 85 years (including 85 …
Contacts

Lin Wu, MD

13170419973

wulin-calf@vip.163.com

CONTACT