A Phase I Study to Explore the Safety and Efficacy of NV-001 in the Treatment of Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- NV-001
- Conditions
- Malignant Neoplasm
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of Participants Experiencing dose-limiting toxicities (DLTs)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
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. The patients will be treated with vaccines generated based on their tumor tissues.Various doses will be tested according to the protocol to get preliminary safety and efficacy evidence.
Investigators
NING LI
Director of Department of Clinical Trial Center
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 phosphatase \< 2.5 x ULN (patients with liver and bone involvement should be ≤ 5 x ULN).
- •C. Renal Function: Serum creatinine ≤ 2.5 x ULN, or creatinine clearance ≥ 30 mL/min, whether actually measured by urine collection or estimated using the Cockcroft-Gault formula.
- •D. coagulation: prothrombin time (PT), International Normalized Ratio (INR), and Partial Thromboplastin Time (PTT) ≤ 1.5 × ULN.
- •presence of biopsy lesions with acceptable clinical risk or lesions amenable to palliative surgical resection. Presence of a tumor lesion amenable to tumor tissue biopsy.
Exclusion Criteria
- •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);
- •has received radiotherapy within 14 days prior to the first dose.
- •has received a live or live attenuated vaccine within 30 days prior to the first dose.
- •use of immunosuppressive drugs currently or within 14 days prior to the first dose.
- •has had major surgery within 28 days or non-study related minor surgery within 7 days prior to the first dose.
- •the patient has a history of allergic or hypersensitivity reactions to any of the components of NV-
- •female patients who are breastfeeding or have a positive serum pregnancy test at the time of the screening visit.
- •insufficient biopsy to complete the experiment
- •any Grade 4 immune-related AE (irAE) on prior immunotherapy (patients with endocrine disorders receiving replacement therapy or experiencing asymptomatic elevations in serum amylase or lipase are eligible for enrollment), any irAE on prior immunotherapy that resulted in permanent discontinuation of therapy, or any Grade 3 irAE within ≤ 6 months prior to initiation of treatment.
- •prior toxicity from antineoplastic therapy that remains at NCI-CTCAE ≥ Grade 2 (except for alopecia, vitiligo, and experimental indications of Grade 2 or higher as defined in the Inclusion Criteria); subjects with neurotoxicity ≥ Grade 2 may be eligible for enrollment at the discretion of the Investigator; subjects with irreversible toxicity may be eligible for enrollment at the discretion of the Investigator.
Arms & Interventions
NV-001
The patients will be treated with vaccines generated based on their tumor tissues.Various doses will be tested according to the protocol.
Intervention: NV-001
Outcomes
Primary Outcomes
Number of Participants Experiencing dose-limiting toxicities (DLTs)
Time Frame: in the first 28 days after the first dose.
Number of Participants Experiencing dose-limiting toxicities (DLTs)
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: From signed ICF until the date of last visit or start new antitumor therapy, whichever comes first, assessed up to 36 months
Number of Participants Experiencing Adverse Events (AEs)
Secondary Outcomes
- Overall Response Rate (ORR)(Up to 36 month)
- Disease Control Rate(DCR)(Up to 36 month)