NCT06051760 NV-001 in the Treatment of Advanced Solid Tumors
| NCT ID | NCT06051760 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Malignant Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2025-03-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study is a single-center, open, dose-escalation Phase I clinical study. It is designed to evaluate the safety, tolerability, preliminary efficacy and immunogenicity of treating NV-001, a king of hybrid-membrane-based tumor vaccine in patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: * patients with histopathologically and/or cytologically confirmed non-surgically resectable advanced/metastatic solid tumors. * patients with progression on prior standard treatment regimens or intolerance to standard treatment or no standard treatment. * an Eastern Cooperative Oncology Group (ECOG) Physical Status (PS) score of 0 or 1 and an expected survival time of ≥12 weeks * confirmed clinical or imaging progression after the most recent antitumor therapy: at least 1 measurable lesion according to RECIST 1.1 criteria. * Substantially normal major organ function and screening laboratory values that meet the following criteria: A. Bone marrow function: absolute neutrophil count ≥ 1000/μL; hemoglobin ≥ 9g/dL; platelet count ≥ 75,000/μL. B. Liver function: serum total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 x ULN (patients with liver metastases should be ≤ 5 x ULN); alkaline phospha