First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)
(FORTITUDE Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
AN
Overseen byAung Naing, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Akamis Bio
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Research Team
AN
Aung Naing, MD
Principal Investigator
The University of Texas MD Anderson Cancer Center
Eligibility Criteria
Inclusion Criteria
Provide written informed consent to participate
Aged 18 years or over
Have one of eleven histologically or cytologically confirmed metastatic or advanced carcinomas or adenocarcinomas that have progressed after at least one line of systemic therapy and are incurable by local therapy
See 7 more
Treatment Details
Interventions
- NG-350A (Virus Therapy)
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland ClinicCleveland, OH
The University of Texas MD Anderson Cancer CenterHouston, TX
University of ColoradoAurora, CO
Memorial Sloan Kettering Cancer Center (MSKCC)New York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Akamis Bio
Lead Sponsor
Trials
13
Recruited
820+
PsiOxus Therapeutics Ltd
Lead Sponsor
Trials
12
Recruited
790+