drugset / Trial / NCT06631079

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

NCT06631079 ↗

Phase 1/2 Active not recruiting 20 enrolled NEC Bio B.V NEC Bio Therapeutics · collab
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2024-10-07
Primary completion
2026-07-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject NECVAX-NEO1 Vaccine — Oral

Indications