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)

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

PRIMARY OBJECTIVE:

To evaluate safety of IV and IT CF33-hNIS in monotherapy and in combination with pembrolizumab. To determine Recommended Phase 2 Dose (RP2D) of CF33-hNIS in monotherapy and in combination with pembrolizumab.

SECONDARY OBJECTIVES:

Anti-tumor activity of CF33-hNIS administered as a monotherapy and in combination with pembrolizumab based on objective response rate (ORR) using RECIST v1.1 (Seymour et al., 2017) and immune Response Evaluation Criteria in Solid Tumors (iRECIST) v1.0
Efficacy of IT and IV CF33-hNIS administered as a monotherapy and in combination with pembrolizumab:
a. Progression-free survival (PFS)
b. Overall survival (OS)
c. Duration of Response (DOR)
d. Disease Control Rate (DCR)
Viral titers of CF33-hNIS
Infection of tumors with CF33-hNIS

Eligibility

Inclusion Criteria:

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:

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

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices