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New treatment option for Malignant Neoplasm
Official title NV-001 in the Treatment of Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06051760
What this study is testing
What is NV-001?
NV-001 is an investigational medicine, being studied as a potential treatment for malignant neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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-001.
See the full eligibility 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...
- 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.
- have an expected survival of more than 12 weeks.
- the patient understands and complies with the study protocol and has signed the appropriate Informed Consent Form (ICF), which must be signed prior to the study procedure. 11. for patients of childbearing potential, the...
- For patients of childbearing potential: Patients should agree to use effective contraception during treatment and for at least 90 days after the last dose of study treatment, including double-barrier contraception...
- 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-001.
- 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...
- 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); people with...
- the presence of clinically significant pulmonary fibrosis or interstitial pneumonitis as determined by the investigator.
- the presence of clinically significant severe ophthalmic disease as determined by the investigator based on screening ophthalmologic examination.
- the presence of other malignant tumors within the previous 5 years, with the exception of cured basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the breast, and carcinoma in situ of the...
- the presence of clinically symptomatic central nervous system tumors or metastases.
- the presence of an active infection including tuberculosis (documented history, investigator judgment and radiology, and local laboratory testing), hepatitis B (hepatitis B surface antigen positive, HBV DNA above the...
- documented primary immunodeficiency or organ transplantation.
- people with a history of active gastrointestinal bleeding, hemoptysis or hemorrhage.
- other conditions that may result in increased risk associated with the study medication, or affect compliance with the trial, which in the opinion of the investigator make participation in this trial inappropriate.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.