OncoMatch/Clinical Trials/NCT06051760
NV-001 in the Treatment of Advanced Solid Tumors
Is NCT06051760 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies NV-001 for malignant neoplasm.
Treatment: NV-001 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic antitumor therapy
has received other systemic antitumor therapy within 28 days or 5 half-lives prior to the first treatment. or has not recovered from the previous treatment (all three cases, whichever is longer)
Cannot have received: radiotherapy
has received radiotherapy within 14 days prior to the first dose
Cannot have received: live or live attenuated vaccine
has received a live or live attenuated vaccine within 30 days prior to the first dose
Cannot have received: immunosuppressive drugs (corticosteroids: prednisone or equivalent)
Exception: topical medications (e.g., ointments, eye drops, inhalers, or nasal sprays) are permitted, and topical medications must not exceed the dose recommended in the insert or if there are any signs of systemic exposure
use of immunosuppressive drugs currently or within 14 days prior to the first dose; prolonged use (≥14 consecutive days) of immunosuppressive or other immunomodulatory drugs (e.g., corticosteroids: prednisone or equivalent) within 6 months
Cannot have received: major surgery
has had major surgery within 28 days or non-study related minor surgery within 7 days prior to the first dose
Lab requirements
Blood counts
absolute neutrophil count ≥ 1000/μL; hemoglobin ≥ 9g/dL; platelet count ≥ 75,000/μL
Kidney function
serum creatinine ≤ 2.5 x ULN, or creatinine clearance ≥ 30 mL/min
Liver function
serum total bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases); alkaline phosphatase < 2.5 x ULN (≤ 5 x ULN with liver and bone involvement)
Substantially normal major organ function and screening laboratory values that meet the following criteria: Bone marrow function: absolute neutrophil count ≥ 1000/μL; hemoglobin ≥ 9g/dL; platelet count ≥ 75,000/μL. Liver function: serum total bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases); alkaline phosphatase < 2.5 x ULN (≤ 5 x ULN with liver and bone involvement). Renal Function: Serum creatinine ≤ 2.5 x ULN, or creatinine clearance ≥ 30 mL/min. coagulation: PT, INR, and PTT ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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