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A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors

NCT05346484 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-03-06

No results posted yet for this study

Summary

This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab or mFOLFOX in patients with metastatic or advanced solid tumors.

Conditions

Interventions

BIOLOGICAL

CF33-hNIS

CF33-hNIS is a chimeric orthopoxvirus (oncolytic virus) engineered to express the human sodium iodide symporter (hNIS)

BIOLOGICAL

Pembrolizumab

Pembrolizumab 200mg administrated IV every 3 weeks (Q3W).

DRUG

Modified FOLFOX

28 day cycle of: * Leucovorin calcium/folinic acid * Fluorouracil * oxaliplatin

Sponsors & Collaborators

  • Imugene Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-17
Primary Completion
2026-01-12
Completion
2026-01-12
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05346484 on ClinicalTrials.gov