A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity o
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).
| Condition(s) | Non-small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 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 carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 5. Have a performance status of 0 on the Eastern Cooperative Onc |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Shanghai Henlius Biotech |
| Locations | Glendale, California, United States; Los Alamitos, California, United States; Los Angeles, California, United States; Los Angeles, California, United States; San Bernardino, California, United States; Deerfield Beach, Florida, United States (+63 more sites) |
| Start date | 2025-09-26 |
| NCT ID | NCT07160335 |
| Official listing | https://clinicaltrials.gov/study/NCT07160335 |