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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    6
  • sponsor
    NEC OncoImmunity AS
Updated on 25 May 2022

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

Description

The trial is conducted as a mono-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.

Details
Condition Solid Tumors, Adult
Treatment NECVAX-NEO1
Clinical Study IdentifierNCT05354323
SponsorNEC OncoImmunity AS
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 65 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
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 fine 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

Exclusion Criteria

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
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
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