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Trial Title:
Safety and Tolerability of Intravenous Administration of ICVB-1042
NCT ID:
NCT05904236
Condition:
Patients with Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Oncolytic virus
First in human
Relapsed solid tumor
Refractory solid tumor
Tumor biopsy
Novel therapy
Metastatic
Previously treated
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Escalating doses
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Treatment with ICVB-1042 administered intravenously
Description:
Part A Dose Escalation to assess safety and tolerability of ascending dose levels, define
the maximum tolerated dose (MTD), and expansion dose(s) Part B Dose Expansion to further
assess safety and tolerability of 1 or more dose levels
Arm group label:
ICVB-1042
Summary:
Study to evaluate the safety and tolerability of intravenous ICVB-1042
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
California Cancer Associates
Address:
City:
San Marcos
Zip:
92069
Country:
United States
Status:
Completed
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
NYU Langone Health, Perlmutter Cancer Center
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
University of North Carolina Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Facility:
Name:
Carolina BioOncology
Address:
City:
Huntersville
Zip:
28078
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
University of Pennsylvania, Abramson Cancer Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Next Oncology, Dallas
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Next Oncology, San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Next Oncology, Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Active, not recruiting
Start date:
May 24, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
IconOVir Bio
Agency class:
Industry
Source:
IconOVir Bio
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05904236
