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Virus Therapy

Intravenous for Cancer (FORTITUDE Trial)

Phase 1
Waitlist Available
Led By Aung Naing, MD
Research Sponsored by Akamis Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study to end of study treatment visit (week 24 or +30 days after last study drug dose)
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Cancer
  • Epithelial Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study to end of study treatment visit (week 24 or +30 days after last study drug dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study to end of study treatment visit (week 24 or +30 days after last study drug dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events, serious adverse events, adverse events meeting protocol-defined DLT criteria, severe adverse events, adverse events leading to study treatment or study discontinuation, and adverse events resulting in death.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IntravenousExperimental Treatment1 Intervention
Patients will receive three single doses of NG-350A by IV infusion, followed by multiple cycles of check point inhibitor treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NG-350A
2019
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Akamis BioLead Sponsor
12 Previous Clinical Trials
792 Total Patients Enrolled
PsiOxus Therapeutics LtdLead Sponsor
11 Previous Clinical Trials
762 Total Patients Enrolled
Aung Naing, MDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center
14 Previous Clinical Trials
1,749 Total Patients Enrolled
~4 spots leftby Oct 2025
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