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

NCT05354323 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: NECVAX-NEO1-LT
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Solid Tumors, Adult

Outcome Measures

Primary Outcomes (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)

  36 weeks

Secondary Outcomes (5)

• Overall Response Rate ORR

  36 weeks

• Progression-Free Survival PFS

  36 weeks

• Time to Progression TTP

  36 weeks

• Overall Survival OS

  36 weeks

• Immune Response

  24 weeks

Other Outcomes (2)

• Intratumoral T-cells

  24 weeks

• Intratumoral Tregs

  24 weeks

Study Arms (1)

NECVAX-NEO1

EXPERIMENTAL

Personalized patient-individual oral DNA vaccine

Biological: NECVAX-NEO1

Interventions

NECVAX-NEO1 BIOLOGICAL

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

NECVAX-NEO1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NEC OncoImmunity AS: lead

Study Sites (3)

Kaunas University Hospital

Kaunas, 50161, Lithuania

Location

National Cancer Institute

Vilnius, 08661, Lithuania

Location

Vilnius University Hospital Santaros Clinics

Vilnius, 08661, Lithuania

Location

Study Officials

• Elona Juozaityte, MD

  Hospital of Lithuanian University of Health Sciences Kauno Klinikos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 29, 2022
• Study Start: May 5, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

LI (3)