NCT06631079

Personalised Neoantigen-targeting Cancer Vaccine NECVAX-NEO1 in Anti-PD-1/PD-L1 Therapy in Patients With Solid Tumors

An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Therapy in Patients With Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: NEC Bio B.V · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase I/II multicenter, open-label, single-arm trial in patients to evaluate the safety and effect of NECVAX-NEO1 administered in combination with PD-1/PD-L1 mABs in patients with solid tumors. Patients with solid tumors who will be treated with approved standard of care (SoC) PD-1 or PD-L1 monoclonal antibody inhibitor therapy, and who after starting treatment with PD-1/PD-L1 inhibitor reached either Stable Disease (SD) or Partial Response (PR) (Cohort 1) or PD (Cohort 2) according to RECIST 1.1 and iRECIST assessed at the Baseline visit may be enrolled in the study

Detailed description

Phase I/II multicenter, open-label, single-arm trial in patients to evaluate the safety and effect of NECVAX-NEO1 administered in combination with PD-1/PD-L1 mABs in patients with solid tumors. Patients with solid tumors who will be treated with approved standard of care (SoC) PD-1 or PD-L1 monoclonal antibody inhibitor therapy, and who after starting treatment with PD-1/PD-L1 inhibitor reached either Stable Disease (SD) or Partial Response (PR) (Cohort 1) or PD (Cohort 2) according to RECIST 1.1 and iRECIST assessed at the Baseline visit may be enrolled in the study. Personalised NECVAX-NEO1 is an oral, bacteria-based therapeutic vaccine that incorporates a sequence of patient-specific neoantigens selected by the NEC Immune Profiler. It is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to specifically recognize and destroy tumor cells based on the patient's own neoantigens. NECVAX-NEO1 will be manufactured as a patient-specific Investigational Medicinal Product (IMP) for add-on therapy to the SoC PD-1/PD-L1 inhibitor therapy. For each patient, the trial will consist of: * Screening visit: To evaluate patients for inclusion in the trial. The patient signs the informed consent form (ICF), eligibility is confirmed, and a biopsy is taken to start manufacturing of the personalized NECVAX-NEO1. * Induction period. This is the SoC treatment period, during which treatment with PD-1/PD-L1 inhibitor therapy is started. This is approximately 8 to 12 weeks, depending on the type of PD-1/PD-L1 inhibitor used. The neoantigen selection and manufacturing of the personalized NECVAX-NEO1 takes place during the induction period. * Baseline visit. At this visit, when the personalized NECVAX-NEO1 treatment is available and the RECIST/iRECIST tumor assessment is performed by magnetic resonance imaging (MRI) or computed tomography (CT) scan, eligibility will be re-confirmed, after which the patient will be assigned to either Cohort 1 (SD or PR according to RECIST 1.1) or Cohort 2 (PD according to RECIST 1.1). * Treatment period of up to 24 weeks which will mark the addition of new therapy to existing therapy, i.e., prime and booster administrations of NECVAX-NEO1 in addition to PD-1/PD-L1 inhibitor. * Post-treatment Follow-up period of 4 weeks, with an End of Treatment (EoT) visit at Week 28. * After the EoT (Week 28), a Long-Term Safety Monitoring Period, following the administration of a genetically modified organism, will occur for up to 24 months.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	NECVAX-NEO1	Bacteria-based orally administered personalised neoantigen-targeting cancer vaccine

Timeline

• Start date: 2024-10-07
• Primary completion: 2026-07-31
• Completion: 2028-12-31
• First posted: 2024-10-08
• Last updated: 2026-01-08

Locations

8 sites across 3 countries: Germany, Lithuania, Spain