NCT04053283

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Akamis Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Metastatic Cancer
• Epithelial Tumor

Interventions

Type	Name	Description
BIOLOGICAL	NG-641	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.

Timeline

• Start date: 2020-01-23
• Primary completion: 2023-08-31
• Completion: 2023-12-20
• First posted: 2019-08-12
• Last updated: 2025-03-24

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study