Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours

Part of paid clinical trials in Fullerton, California.

Sponsor
Akamis Bio
Study ID
NCT05043714
Phase
PHASE1
Status
Completed

Conditions

  • Epithelial Tumor
  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NG-641 in combination with Nivolumab — BIOLOGICAL
    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. Nivolumab is a human monoclonal antibody that targets the PD-1 cluster of differentiation 279 cell surface membrane receptor.

Study Details

This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-641 in combination with nivolumab (or standard of care PD-1 inhibition) in patients with metastatic or advanced epithelial tumours. The purpose is 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

Key Dates

Start date
Dec 1, 2021
Status verified
Aug 2024
Primary completion
Nov 13, 2023
Completion
Oct 4, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Intravenous
    Phase 1a Part A: One cycle (28 days) of NG-641 on Days 1, 3 and 5 and nivolumab on Day 15, followed by nivolumab every 4 weeks. Phase 1a Part B: NG-641 on Days 1, 3 and 5 and one nivolumab on Day 15 in each of up to eight 28-day cycles.

Primary Outcome Measure

Incidence of adverse events (safety and tolerability) in study of NG-641 in combination with nivolumab [ Time Frame: 30 days after last dose of study drug ]

Locations (4)

FacilityCityStateZIPSite coordinators
Providence Medical FoundationFullertonCalifornia92835-
UCLA Department of MedicineSanta MonicaCalifornia90404-
Moffitt-Advent Health Clinical Research UnitCelebrationFlorida34747-
University of Cincinnati Cancer CenterCincinnatiOhio45267-

Find similar trials in Fullerton, CA

By research site
Providence Medical Foundation· Fullerton, CAUCLA Department of Medicine· Santa Monica, CAMoffitt-Advent Health Clinical Research Unit· Celebration, FLUniversity of Cincinnati Cancer Center· Cincinnati, OH

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