Neoplasms

Symptoms and General Pathology

All Conditions

Infections

Neoplasm Metastasis

Virus Diseases

Neoplasms, Glandular and Epithelial

Neoplastic Processes

Neoplasms by Histologic Type

All Drugs and Chemicals

Antibodies

Immunoglobulins

Patients will receive three single doses of NG-350A by IV infusion, followed by multiple cycles of check point inhibitor treatment.

NG-350A is oncolytic adenoviral vector which expresses a full length agonist anti-CD40 antibody at the site of virus replication.

NG-350A

Aung Naing, MD

This study will evaluate the safety, tolerability and preliminary efficacy and also pharmacokinetics, immunogenicity and other pharmacodynamic effects to elucidate the mechanism of action of NG-350A, either alone or in combination with a check point inhibitor, in patients with advanced or metastatic epithelial tumours.

Phase Ia of this study is a dose escalation phase, investigating NG-350A administration by intravenous (IV) infusion, either alone or in combination with a check point inhibitor. Phase Ib of this study comprises of a Combination Dose Efficacy Expansion with NG-350A in combination with a check point inhibitor.

Patients in Part A will receive a single cycle of NG-350A study treatment, with three single doses on Days 1, 3 and 5 by IV infusion.

Patients in Part B will receive a single cycle of NG-350A study treatment, with three single doses on Days 1, 3 and 5 by IV infusion, followed by up to 8 cycles of a check point inhibitor.

First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)

A Multicentre, Open Label, Non-randomised First in Human Study of NG-350A (Monotherapy), and NG-350A With a Check Point Inhibitor in Patients With Metastatic or Advanced Epithelial Tumours

Characterise the safety and tolerability of NG-350A, in combination with a check point inhibitor, by reviewing reported Adverse Events (AEs) and Serious Adverse Events (SAEs).

Akamis Bio

Anti-Inflammatory Agents

Anti-Infective Agents

Antineoplastic Agents

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Interferon-alpha

Interferon alpha-2

Phase 1a dose escalation: one cycle of treatment.

Phase 1a dose optimisation: up to 8 cycles of treatment

NG-641 is a replication competent adenoviral vector producing a bispecific T cell activator (TAc) targeting fibroblast activation protein (FAP) plus immune enhancer genes CXCL9/CXCL10/IFNa2. This can lead to killing of tumor cells and stimulation of immunity against the tumor cells.

NG-641

Gloria Bryant

Heinz-Josef Lenz

Rose Estrada

Lee Rosen

Felipe Valerio

Guru Sonpavde

To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.

To characterise the safety and tolerability of NG-641 in patients with metastatic or advanced epithelial tumours.

The Phase 1a part of the study is a dose-escalation and dose-optimization phase investigating NG-641 administration by intravenous (IV) infusion in a range of tumour types.

The Phase 1b part of the study will investigate the selected optimized multicycle dosing regimen as a monotherapy in up to three cohorts of patients with specific tumour types (Dose Expansion Cohorts A, B and C).

First in Human Study With NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector

A Multicentre, Open-label, Non-randomised First in Human Study of NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector, in Patients With Metastatic or Advanced Epithelial Tumours (STAR)

Incidence of adverse events, adverse events meeting protocol-defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.

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

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

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Nivolumab

enadenotucirev

nivolumab

Tom Lillie, MD

This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with focus on CRC, SCCHN, escalation phase), not responding to standard therapy.

To characterise the safety and tolerability of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumours.

A dose escalation phase is conducted in subjects with solid tumors of epithelial origin not responding to standard therapy to establish the MTD/MFD and optimum dosing schedule of the enadenotucirev and nivolumab combination treatment.

A dose expansion phase will further outline the dose level and schedule of enadenotucirev and nivolumab combination treatment and investigate signals of efficacy in three cohorts of subjects with specific epithelial tumour types.

Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors

A Phase I Multicenter, Open Label Study of Enadenotucirev Combined With PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors

Review of adverse events including serious adverse events (SAEs), adverse events meeting protocol defined DLT criteria, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death

Maximum tolerated dose (MTD) / maximum feasible dose (MFD) of enadenotucirev administered IV in combination with nivolumab.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)	NCT03852511	Metastatic Canc... Epithelial Tumo...	NG-350A	18 Years -	Akamis Bio
First in Human Study With NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector	NCT04053283	Metastatic Canc... Epithelial Tumo...	NG-641	18 Years -	Akamis Bio
Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY)	NCT05165433	Epithelial Tumo... Metastatic Canc...	NG-350A plus Pe...	18 Years -	Akamis Bio
Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors	NCT02636036	Colorectal Canc... Squamous Cell C... Epithelial Tumo...	enadenotucirev nivolumab	18 Years -	Akamis Bio
Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors	NCT02636036	Colorectal Canc... Squamous Cell C... Epithelial Tumo...	enadenotucirev nivolumab	18 Years -	Akamis Bio

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