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

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 Details

NCT ID
NCT07160335
Phase
PHASE1
Sponsor
Shanghai Henlius Biotech
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • HLX17
  • US-sourced Keytruda®
Locations (sample)
  • Glendale, California, United States|34.14251,-118.25508
  • Los Angeles, California, United States|34.05223,-118.24368
  • Deerfield Beach, Florida, United States|26.31841,-80.09977
  • Ocala, Florida, United States|29.1872,-82.14009
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Participants must have signed and dated an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written informed consent form…
  • At least 18 years and no older than 85 years (including 85 years old) at the time of signing the ICF.
  • 18 kg/m2 ≤ body mass index (BMI) ≤ 30 kg/m2 and 50 kg ≤ body weight ≤ 85 kg.
  • The patient with one of the following resected solid tumors:

For full eligibility, visit ClinicalTrials.gov.

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