Neoplasms

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Neoplasm Metastasis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive three doses of NG-350A by intravenous infusion and a single dose of Pembrolizumab by intravenous infusion

NG-350A plus Pembrolizumab

Akamis Bio Ltd

Clinical Trials Office

David Park, MD

Christopher Lim

Lee Rosen, MD

Amy Whitaker

Guru Sonpavde, MD

Jennifer Louie

Mark O'Hara, MD

Yali Yang, PhD

Aung Naing, MD

Maria Maguire

Christian Ottensmeier, MD

Richard Cousins

Eileen Parkes, MD

This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-350A in combination with pembrolizumab in patients with metastatic or advanced epithelial tumours.

Phase 1a will investigate NG-350A administration by intravenous (IV) infusion in combination with fixed-dose pembrolizumab in patients with metastatic or advanced tumours.

Phase 1b will further investigate the efficacy and safety of the selected dose regimen in up to three of the tumour types evaluated in Phase 1a.

Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY)

A Multicentre, Open-label, Non-randomized, Phase 1a/1b Study of NG-350A, a Tumour-selective Anti-CD40-expressing Adenoviral Vector, in Combination With Pembrolizumab in Patients With Metastatic or Advanced Epithelial Tumours

Assess the safety and tolerability of NG-350A in combination with pembrolizumab by review of adverse events including serious adverse events, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.

Merck Sharp & Dohme LLC

Akamis Bio

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