The Phase 1a part of the study is is a dose-escalation phase investigating NG-641 administration by intravenous (IV) infusion in combination with fixed doses of nivolumab in a range of tumour types. Patients eligible for Phase 1a will have metastatic or advanced disease after failure of prior anti-programmed cell death 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) therapy. Dose escalation will be governed by the Bayesian Optimal Interval (BOIN) design, with up to four dose-escalation cohorts planned, plus an optional dose de-escalation cohort.~The Phase 1b part of the study will further investigate the efficacy and safety of the selected dose regimen in up to three of the tumour types evaluated in phase 1b (tumour-specific Dose Expansion Cohorts A, B and C). Patients eligible for Phase 1b will have metastatic or advanced disease and primary resistance to anti-PD-1 or anti-PD-L1 therapy.~Following treatment, patients will be followed every 8 weeks for 12 months for tumour imaging and evaluation (until disease progression), overall survival and outcomes on further treatment.
This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-641 in combination with nivolumab in patients with metastatic or advanced epithelial tumours.~To characterize the safety and tolerability of NG-641 in combination with nivolumab in patients with metastatic or advanced epithelial tumours and to determine the recommended dose of NG-641 in combination with nivolumab for further development in patients with metastatic or advanced epithelial tumours