NCT03120832

Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients

Phase 1, Open Label Trial to Evaluate the Safety and Immunogenicity of PAN-301-1 in Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Sensei Biotherapeutics, Inc. · Industry
• Sex: Male
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, open-label, parallel design study of PAN-301-1 (SNS-301), a HAAH directed nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed prostate cancer, using a fixed dose escalation schema every 21 days.

Detailed description

Human aspartyl-asparaginyl-β-hydroxylase (HAAH), also known as aspartate-β-hydroxylase, is an \~86 kDa type 2 transmembrane protein that belongs to the α-ketoglutarate-dependent dioxygenase family. It is a highly conserved enzyme, which catalyzes the hydroxylation of aspartyl and asparaginyl residues in epidermal growth factor-like domains of proteins including Notch and homologs. HAAH was initially identified in a novel screen to identify cell surface proteins up-regulated in liver cancer. It has subsequently been detected in a diverse array of solid and blood cancers, including: liver, bile duct, brain, breast, colon, prostate, ovary, pancreas, and lung cancers as well as leukemia. HAAH is not found in significant quantities in normal tissue or in proliferative disorders. The investigators have designed a bacteriophage lambda system to display HAAH peptides fused at the C terminus of the head protein gpD of phage lambda. The phage carry 200-300 copies of the gpD protein on their head and thus display many copies of an approximately 25 kDa molecular weight fragment of HAAH on their surface. The drug substance is one of these HAAH bacteriophage lambda constructs: HAAH-1λ (PAN-301-1). This study evaluates the safety and immunogenicity of the PAN-301-1 vaccine in patients with biochemically-relapsed prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	PAN-301-1

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-04-19
• Last updated: 2021-11-12
• Results posted: 2021-11-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study