Clinical trial NCT05904236: Safety and Tolerability of Intravenous Administration of ICVB-1042
Official title: Phase 1 First-in-Human Dose Escalation and Expansion Study to Assess Safety and Tolerability of Intravenous Administration of ICVB-1042 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Patients With Advanced Solid Tumors
Keywords: Oncolytic virus
First in human
Relapsed solid tumor
Refractory solid tumor
Tumor biopsy
Novel therapy
Metastatic
Previously treated
Lead sponsor: IconOVir Bio
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Escalating doses
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety and tolerability of intravenous ICVB-1042


Eligibility criteria: Inclusion Criteria:

* Adult patients with relapsed or refractory locally advanced or metastatic solid tumors who have progressed on or after at least one prior line of standard of care therapy including immune checkpoint inhibitors and targeted therapies for known molecular alterations if present
* Measurable disease according to RECIST v1.1
* ECOG Performance Status 0 or 1
* Life expectancy of at least 3 months

Exclusion Criteria:

* Prior SOC or other treatment with a biologic (eg, mAb) within 28 days prior to dosing or 5×half-life, whichever is longer from investigational therapy
* Major surgical procedures within 28 days prior to dosing
* Limited field irradiation for palliation within 14 days prior to dosing
* Anti-viral agents, vaccinations within 28 days prior to dosing
* Known central nervous system (CNS) metastases unless adequately treated and clinically stable without steroids for ≥14 days
* Leptomeningeal carcinomatosis
* Pulmonary lymphangitic spread of cancer
* History of clinically significant cardiovascular abnormalities
* Known active infection requiring systemic antibiotic therapy or systemic antifungal therapy
* Known active HIV, hepatitis B or C, or other active viral disease
* Known hematologic malignancies (requiring or not requiring active therapy).
* Requirement for immunosuppressive therapy (ie, prednisone equivalent of \>10 mg/day)
* Women who are pregnant or lactating
* Oxygen saturation measured with Pulse oximeter \<90% and/or on supplemental O2

Primary outcomes:
measure: Safety of intravenous ICVB-1042
timeFrame: From dose administration through 12 weeks
Secondary outcomes:
measure: Concentration profile of ICVB-1042 in plasma
timeFrame: Up to 48 hours after drug infusion
measure: Determine immunogenicity of ICVB-1042
timeFrame: From dose administration through 12 weeks
Other outcomes:
measure: Evaluate shedding of ICVB-1042
timeFrame: At study visits from dose administration through 12 weeks
measure: Tumor response by RECIST criteria
timeFrame: Day 57
measure: Concentration of ICVB-1042 in tumor biopsy
timeFrame: Day 57
measure: Number of patients with immunoreactivity to ICVB-1042 administration
timeFrame: At study visits from dose administration through 12 weeks
measure: Number of patients with changes in cell-free tumor DNA
timeFrame: At study visits on Day 1, Day 10, Day 29, Day 57, Day 85 or Early Termination visit
measure: Evaluate viral replication
timeFrame: At study visits from dose administration through 12 weeks
measure: Viral titer of ICVB-1042
timeFrame: At study visits from dose administration through 12 weeks
Locations:
city: San Marcos
country: United States
facility: California Cancer Associates
state: California
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: New York
country: United States
facility: NYU Langone Health, Perlmutter Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Lineberger Comprehensive Cancer Center
state: North Carolina
city: Huntersville
country: United States
facility: Carolina BioOncology
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania, Abramson Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Irving
country: United States
facility: Next Oncology, Dallas
state: Texas
city: San Antonio
country: United States
facility: Next Oncology, San Antonio
state: Texas
city: Fairfax
country: United States
facility: Next Oncology, Virginia
state: Virginia
Study officials:
affiliation: IconOVir Bio
name: Julie Maltzman, MD
role: STUDY_DIRECTOR
References: