Actively Recruiting
NV-001 in the Treatment of Advanced Solid Tumors
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-02-12
20
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NV-001 in the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histopathologically and/or cytologically confirmed non-surgically resectable advanced or metastatic solid tumors.
- Patients who have progressed on prior standard treatments, are intolerant to them, or have no standard treatments.
- Eastern Cooperative Oncology Group (ECOG) Physical Status score of 0 or 1.
- Expected survival time of at least 12 weeks.
- Confirmed clinical or imaging evidence of tumor progression after recent antitumor therapy with at least one measurable lesion per RECIST 1.1 criteria.
- Substantially normal major organ function and laboratory values, including bone marrow, liver, renal, and coagulation parameters within specified limits.
- Presence of biopsy lesions with acceptable clinical risk or lesions suitable for palliative surgical resection.
- Patients understand and agree to comply with the study protocol and have signed informed consent.
- For patients of childbearing potential, agreement to use effective contraception during treatment and for at least 90 days after the last dose, with male patients agreeing to avoid sperm donation.
You will not qualify if you...
- Received systemic antitumor therapy within 28 days or 5 half-lives prior to first treatment and not recovered from prior treatment.
- Received radiotherapy within 14 days prior to first dose.
- Received live or live attenuated vaccine within 30 days prior to first dose.
- Use of immunosuppressive drugs currently or within 14 days prior to first dose.
- Major surgery within 28 days or minor non-study surgery within 7 days prior to first dose.
- History of allergic or hypersensitivity reactions to components of NV-001.
- Female patients who are breastfeeding or have a positive pregnancy test at screening.
- Insufficient biopsy tissue to complete study procedures.
- History of severe immune-related adverse events from prior immunotherapy or recent Grade 3 immune-related adverse events.
- Persistent Grade 2 or higher toxicity from previous antineoplastic therapy, except certain exceptions.
- Clinically significant pulmonary fibrosis or interstitial pneumonitis.
- Clinically significant severe eye disease.
- Other malignant tumors within past 5 years, except some specified cured cancers.
- Prolonged use of systemic immunosuppressive or immunomodulatory drugs within last 6 months, except certain topical medications.
- History of organ transplantation or primary immunodeficiency.
- Clinically symptomatic central nervous system tumors or metastases.
- Active infections including tuberculosis, hepatitis B or C, and HIV, unless controlled and monitored.
- History of active gastrointestinal bleeding, hemoptysis, or hemorrhage.
- Other conditions increasing risk or affecting compliance as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
D
Dr. Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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