A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumors (MAST).

June 5, 2024

Study Name
	A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumors (MAST).
ClinicalTrials.gov Identifier (if applicable)
	NCT05346484
Clinical Trial Category (check all that apply)
	Beyond First Line Therapy Immunotherapy
Study Center
Institution Name
	City of Hope Medical Center
Institution Address
	1500 East Duarte Road
City
	Duarte
State
	California
Zip Code
	91010
Country
	United States
Study Contacts
Principal Investigator
	Dr. Dan Li
P.I. Phone
	(626) 471-9200
Study Coordinator
	Aruna Parikh
Study Coordinator Phone
	(626) 471-9200
Study Coordinator Email
	arparikh@coh.org
List additional Study Coordinators (include phone number and email)
	Dr. Alexander Spira NEXT Oncology Fairfax, Virginia Contact: Hoda Kassab Dr. Hirva Mamdani Barbara Ann Karmanos Cancer Institute Detroit, Michigan Contact: Kelly Schneider Dr. Wallace AKerly Huntsman Cancer Institute Salt Lake City, Utah Contact Susan Sharry Dr. Jennifer Leddon University of Cincinnati Cincinnati, Ohio Contact: Kayla Webb Dr. Patrick Travis Highlands Oncology Springdale, Arkansas Contact: Morgan Burns Dr. Jaime Merchan University of Miami Miami, Florida Contact: Fernandez Marrero Dr. Gregory Daniels UC San Diego Moores Cancer Center La Jolla, California Contact: Katie O’Neill croneil@health.ucsd.edu Dr. Abhijeet Kumar University of Arizona Cancer Center Tucson, Arizona Contact: Megan Hodges mhodges@arizona.edu Dr. Emerson Lim Corewell Health Grand Rapids, Michigan Contact: Aaron Cole. aaron.cole@corewellhealth.org Dr. Gavin Wright St. Vincent’s Hospital Fitzroy, VIC, Australia Contact: Jane Mack
OVERVIEW – in layman’s terms (150 words max)
	Open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab in patients with metastatic or advanced solid tumors.
Enrollment
	approximately 100
Study Start Date
	05/17/2022
Estimated Completion Date
	10/31/2025
Inclusion Criteria – Patients Must:
	Written informed consent from patient or legally authorized representative Age ≥ 18 years old on the date of consent Any metastatic or advanced solid tumor with documented radiological progression following at least two prior lines of treatment (which may have included prior immune checkpoint inhibitor treatment) ECOG performance status 0 – 2 At least one measurable lesion Adequate renal function Adequate liver function Adequate hematologic function Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria – Patients Must NOT:
	Prior treatment with a poxvirus based oncolytic virus. Continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. Prior radiotherapy within 2 weeks of start of study treatment. Active autoimmune disease Prior allogenic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state Inadequate pulmonary function per Investigator assessment. Uncontrolled brain or other central nervous system (CNS) metastases. History of documented congestive heart failure (New York Heart Association [NYHA] class III – IV), unstable angina, poorly controlled hypertension, clinically significant valvular heart disease or high-risk uncontrolled arrhythmias
Financial Assistance is available to participants for travel, lodging, etc.
	Yes