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Solid Tumors, AdultPhase 1NCT05354323

NECVAX-NEO1 in Addition to Checkpoint Inhibitor in Patients With Solid Tumors

A Phase 1 study testing NECVAX-NEO1 in people with Solid Tumors, Adult, run by NEC OncoImmunity AS at 3 sites in Lithuania.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

NECVAX-NEO1 in addition to anti-PD-1 or anti-PD-L1 monoclonal antibody checkpoint inhibitor monotherapy in n=6 patients with solid tumors Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumors, Adult
What is being tested?
NECVAX-NEO1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
3 sitesLithuania
Study dates
5 May 2022to 31 Dec 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 able to understand and follow instructions during the trial.
  • Patients able and willing to give written informed consent, signed and dated.
  • Male or female patients.
  • Patients aged 18 to 75 years old inclusive at the time of ICF signature.
  • Cancer patients with measurable disease according to RECIST 1.1, treated for at least three (3) months with an anti-PD-1 or anti-PDL1 checkpoint inhibitor as first- or second-line monotherapy, according to the Summary of Product Characteristics (SmPC) and national/institutional guidelines, for one of the following tumor types:
  • non-small cell lung cancer, or
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  • cutaneous melanoma, or
  • urothelial carcinoma, or
  • renal cell carcinoma, or
  • squamous cell cancer of head and neck.
  • Patients with SD or PR according to RECIST 1.1 at Screening
  • Patients with tumor or metastasis accessible for guided needle biopsy or resectable tumor in case of cutaneous melanoma when needle biopsy is not performed.
  • Patients with adequate bone marrow function, including:
  • ANC ≥ 1.5 × 109/L; patients with documented benign cyclical neutropenia are allowed if white blood cell count is ≥ 1.5 × 10E9/L, with ANC ≥ 1.0 × 10E9/L, leukocytes ≥ 4.0 × 10E9/L, and lymphocytes ≥ 0.6 × 10E9/L;
  • platelets ≥ 100 × 10E9/L;
  • hemoglobin ≥ 9 g/dL (may have been transfused);
  • International Normalized Ratio (INR) < 1.5 × Upper Limit of Normal (ULN); patients treated with vitamin K antagonist are eligible if INR < 3.
  • Patients with adequate hepatic function at Screening, confirmed at Baseline, defined by
  • total bilirubin level ≤ 1.5 × ULN; patients with documented Gilbert disease are allowed if total bilirubin ≤ 3 × ULN;
  • aspartate aminotransferase (AST) level ≤ 2.5 × ULN, and alanine aminotransferase (ALT) level ≤ 2.5 × ULN, or, for patients with documented metastatic disease to the liver, AST and ALT levels ≤ 5 × ULN.
  • Patients with adequate renal function at Screening, confirmed at Baseline, defined by an estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula.
  • Patients must be able to undergo MRI or CT scan for tumor follow-up.
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Life expectancy of at least six (6) months according to the Investigator's judgement.

Who cannot join

  • Medical and surgical history, and diseases
  • History of any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, based on the Investigator's judgement, provides a reasonable suspicion of a disease or condition that contraindicates the use of the IMP or that might affect the interpretation of the trial results or render the patient at high risk for treatment complications.
  • Brain metastasis.
  • Previously reported immune-related checkpoint inhibitor side effects of CTCAE Grade 3 or higher not having resolved to Grade 1 within six (6) weeks before inclusion.
  • Any significant co-morbidity which, according to the Investigator's judgement, makes patient compliance to trial conditions unlikely.
  • Previous malignant disease (other than the tumor disease for this trial) within the last five (5) years (except adequately treated non-melanoma skin cancers and carcinoma in situ of skin, bladder, cervix, colon/rectum, breast, or prostate) unless a complete remission without further recurrence was achieved at least two (2) years prior to Screening, and the patient is deemed to have been cured with no additional therapy required or anticipated to be required.
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  • Prior organ transplantation, including allogeneic stem cell transplantation.
  • Congenital or any other immunodeficiency syndromes, or any active autoimmune disease that might deteriorate when receiving an immunostimulatory agent, except for:
  • patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment, who are eligible.
  • administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation), which is acceptable.
  • History of uncontrolled intercurrent illness, including but not limited to uncontrolled diabetes (e.g., hemoglobin A1c ≥ 8%);
  • Known prior hypersensitivity to the IMP or any component in its formulations or any other drug scheduled or likely to be given during the trial, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3).
  • Persisting toxicity related to prior therapy (NCI CTCAE v5.0 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 AEs not constituting a safety risk based on Investigator's judgement are acceptable.
  • Other severe acute or chronic medical conditions, including immune colitis, inflammatory bowel disease, history of severe vomiting or diarrhea not having resolved to Grade 1 at Baseline, immune pneumonitis, pulmonary fibrosis, or psychiatric conditions including recent (within the last year) or active suicidal ideation or behavior, or laboratory abnormalities that may increase the risk associated with trial participation or trial treatment administration or may interfere with the interpretation of trial results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this trial.
  • History of small intestine resection surgery or other major gastrointestinal surgery.
  • Active infection requiring systemic therapy.
  • Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome or multi-drug resistant gram-negative bacteria.
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody Screening test positive).
  • Women of childbearing potential. Prior and concomitant medication
  • Live vaccines within 30 days prior to trial treatment.
  • Treatment in any other clinical trial within 30 days or within five (5) half-lives of any prior treatment, before Screening;
  • Any other condition or treatment that, in the opinion of the Investigator, might interfere with the trial, or current drug or substance abuse;
  • Chronic concurrent therapy within two (2) weeks before the trial treatment or expected therapy during the trial treatment period with:
  • corticosteroids (except steroids up to equivalent of dexamethasone 4 mg daily dose).
  • immunosuppressive agents.
  • antibiotics.
  • any other anticancer therapy or concurrent anticancer treatment, for example, cytoreductive therapy, radiotherapy [with the exception of palliative short course, limited field (ie, ≤ 10 fractions and ≤ 30% bone marrow involvement or per institutional standard) radiotherapy, which may be administered during the trial. However, IMP dosing must be suspended at least 14 days prior to the start of radiotherapy and must not be resumed until at least 14 days after the last radiotherapy fraction], immune therapy, or cytokine therapy, except for erythropoietin.
  • Other
  • Inability to understand the Protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial.
  • Unlikely to comply with the Protocol requirements, instructions and trial-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial.
  • Legal incapacity or limited legal capacity.
  • Any condition which results in an undue risk for the patient during the trial participation according to the Investigator.

Trial locations and contacts

3 sites in 1 country.

Lithuania3 sites

  • Kaunas University Hospital

    Kaunas, 50161

  • National Cancer Institute

    Vilnius, 08661

  • Vilnius University Hospital Santaros Clinics

    Vilnius, 08661

Other trials in Lithuania

About this study

Official title: An Open-label, Phase I Multicenter, Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Checkpoint Inhibitor Monotherapy in Patients With Solid Tumors

NECVAX-NEO1 in addition to anti-PD-1 or anti-PD-L1 monoclonal antibody checkpoint inhibitor monotherapy in n=6 patients with solid tumors

Read the detailed description

The trial is conducted as a multi-centre, open label, single-arm phase 1 first-in-human trial to evaluate NECVAX-NEO1, a personalized investigational oral cancer immunotherapeutic investigational medicinal product in n=6 patients with solid tumors under anti-PD-1 or anti-PD-L1 monoclonal checkpoint inhibitor monotherapy.

The trial has been designed to assess safety and tolerability of NECVAX-NEO1, at two dose levels as well as efficacy signals of NECVAX-NEO1 and immuno- and biomarkers in tumor tissue and blood samples pre- and post treatment.

The trial will include patients with a diagnosis of either non-small cell lung cancer (NSCLC), melanoma, urothelial cancer, renal cell cancer (RCC), or squamous cell cancer of head and neck (SCCHN). Neoantigen epitopes as patient-individual tumor-specific drug targets will be selected and identified by the NEC OncoImmunity proprietary machine-learning and artificial intelligence technology.

Being tested
NECVAX-NEO1

What participants receive

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

  • NECVAX-NEO1Biological

    Oral Ty21a based T-cell vaccination, personalized patient-individual NECVAX-NEO1 constructs containing a eukaryotic expression plasmid encoding for a series of selected neoantigen epitopes

Study groups in NCT05354323
Study groupRoleWhat they receive
NECVAX-NEO1ExperimentalPersonalized patient-individual oral DNA vaccine
Receives: Biological: NECVAX-NEO1

What is being measured

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

  1. Treatment-emergent adverse events

    AEs listed including system organ class, preferred term, severity, causality and other possibly relevant information. Frequency tables (including both patient and event counts) by System Organ Class (SOC) and preferred term (in number and percentage)

    Measured: 36 weeks

Secondary outcomes (5)

  1. Overall Response Rate ORR

    ORR according to RECIST 1.1 with frequencies and percentages (in number and percentage)

    Measured: 36 weeks

  2. Progression-Free Survival PFS

    PFS measured from the date of enrolment to the date of first documentation of progression or death (from any cause), whichever occurs first (in days).

    Measured: 36 weeks

  3. Time to Progression TTP

    TTP measured from the date of enrolment to the date of first documentation of progression or death (from any cause), whichever occurs first, but deaths from other causes are censored at the date of death (in days)

    Measured: 36 weeks

  4. Overall Survival OS

    OS measured from the date of enrolment to the date of death resulting from any cause. Patients alive are censored at the time of last follow-up (in days).

    Measured: 36 weeks

  5. Immune Response

    ELISpot by descriptive analysis including changes from baseline at each post-baseline visit (in spot counts)

    Measured: 24 weeks

Timeline

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

  1. First posted29 Apr 2022
  2. Study start5 May 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05354323
Sponsor's protocol ID
NECVAX-NEO1-LT
Status last verified
Jun 2025
First submitted
19 Apr 2022
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NECVAX-NEO1 in people with Solid Tumors, Adult, run by NEC OncoImmunity AS at 3 sites in Lithuania.

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 24 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Lithuania. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-emergent adverse events (time frame: 36 weeks). 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 NCT05354323.

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 26 Jun 2025.

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