A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17… (NCT07160335) | Clinical Trial Compass
RecruitingPhase 1
A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
United States174 participantsStarted 2025-09-26
Plain-language 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
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
✓. At least 18 years and no older than 75 years (including 75 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:
✓. Have a performance status of 0 on the Eastern Cooperative Oncology Group (ECOG) Performance Status within 7 days prior to the first dose in this study.
✓. Have a life expectancy of at least 12 weeks.
✓. Have adequate organ function as indicated by the following laboratory values (no blood transfusions, or treatment with albumin, recombinant human thrombopoietin or colony-stimulating factor within 14 days prior to the first dose in this study)
✓. Female patients must meet one of the following conditions:
Exclusion criteria
✕. Pregnant or lactating women.
✕. History of illicit drug use or alcohol abuse within 12 months prior to randomization in the investigator's judgment.
✕. Participants with NSCLC have two synchronous primary non-small cell lung cancers or other histopathological types (such as mixed adenosquamous carcinoma, small cell lung cancer, or neuroendocrine carcinoma)； known positive for EGFR sensitive mutations or ALK fusion. EGFR sensitive mutations include: exon 19 deletion mutation (19DEL) and exon 21 point mutation (21L858R).
What they're measuring
1
AUC0-21d
Timeframe: rom time 0 to 21 days after the 1st dose (3 weeks)
2
AUCss
Timeframe: from time 0 to 21 days after the 6th dose (18 weeks)