AzTrials
AzTrials

Malignant NeoplasmPhase 1NCT06051760

NV-001 in the Treatment of Advanced Solid Tumors

A Phase 1 study testing NV-001 in people with Malignant Neoplasm, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Neoplasm
What is being tested?
NV-001
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Dec 2023to 1 Jun 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Bone marrow function: absolute neutrophil count ≥ 1000/μL; hemoglobin ≥ 9g/dL; platelet count ≥ 75,000/μL.
Show all 13Show fewer
  • 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).
  • 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.
  • 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.
  • 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 patient must be able to understand and comply with the study protocol.
  • 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, condoms, contraceptive pills or injectables, and intrauterine devices (IUDs). Male patients should agree to avoid sperm donation.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • 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 cervix.
  • prolonged use (≥14 consecutive days) of immunosuppressive or other immunomodulatory drugs (e.g., corticosteroids: prednisone or equivalent) within 6 months, except that 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; or other acquired or congenital immunodeficiency diseases; or History of organ transplantation.
  • 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 lower limit of detection), hepatitis C (HCV antibody positive, HCV RNA positive), HIV (HIV antibody positive), and enrolled patients with viral load-negative HBV or HCV who have consented to Antiviral therapy and/or regular viral indicator monitoring as determined by the physician.
  • documented primary immunodeficiency or organ transplantation.
  • subjects 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Wang contact

86(010)87788495

snowflake201@gmail.com

China1 site, 1 recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Ning Li

    Ning Li

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study to Explore the Safety and Efficacy of NV-001 in the Treatment of Advanced Solid Tumors

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.

Read the 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.

Being tested
NV-001
Keywords
Advanced solid tumor, Tumor vaccine
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NV-001Biological

    NV-001 is a type of tumor vaccine generated by hybridization of the tumor cell membrane and adjuvant membrane to stimulate the immune reactions against cancer cells.

Study groups in NCT06051760
Study groupRoleWhat they receive
NV-001ExperimentalThe patients will be treated with vaccines generated based on their tumor tissues.Various doses will be tested according to the protocol.
Receives: Biological: NV-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing dose-limiting toxicities (DLTs)

    Number of Participants Experiencing dose-limiting toxicities (DLTs)

    Measured: in the first 28 days after the first dose.

  2. Number of Participants Experiencing Adverse Events (AEs)

    Number of Participants Experiencing Adverse Events (AEs)

    Measured: From signed ICF until the date of last visit or start new antitumor therapy, whichever comes first, assessed up to 36 months

Secondary outcomes (2)

  1. Overall Response Rate (ORR)

    Overall Response Rate (ORR)

    Measured: Up to 36 month

  2. Disease Control Rate(DCR)

    Disease Control Rate(DCR)

    Measured: Up to 36 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start1 Dec 2023
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06051760
Sponsor's protocol ID
NV-001
Status last verified
Feb 2025
First submitted
26 Jul 2023
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NV-001 in people with Malignant Neoplasm, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr. Wang (86(010)87788495, snowflake201@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing dose-limiting toxicities (DLTs) (time frame: in the first 28 days after the first dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06051760.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in