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
Shanghai Henlius Biotech
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).
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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 75 years (including 75 years old) at the time of signing the ICF. 3. 18 kg/m2 ≤ body mass index (BMI) ≤ 30 kg/m2 and 50 kg ≤ body weight ≤ 85 kg. 4. The patient with one of the following resected solid tumors: * NSCLC patients after complete resection OR * Melanoma following complete resection OR * Renal cell ca…
Interventions
- DrugHLX17
Subjects will receive HLX17 (200 mg) on Day 1 of each 3-week cycle
- DrugUS-sourced Keytruda®
Subjects will receive US-sourced Keytruda® (200 mg) on Day 1 of each 3-week cycle
Locations (69)
- Oncology Physicians Network (OPN) - GlendaleGlendale, California
- Oncology Physicians Network (OPN)- Los AlamitosLos Alamitos, California
- HCALos Angeles, California
- Los Angeles Cancer NetworkLos Angeles, California
- Oncology Physicians Network (OPN) - San BernardinoSan Bernardino, California
- BRCR GlobalDeerfield Beach, Florida