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Safety and Tolerability of Intravenous Administration of ICVB-1042

Primary Purpose

Patients With Advanced Solid Tumors

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treatment with ICVB-1042 administered intravenously
Sponsored by
IconOVir Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Advanced Solid Tumors focused on measuring Oncolytic virus, First in human, Relapsed solid tumor, Refractory solid tumor, Tumor biopsy, Novel therapy, Metastatic, Previously treated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Cancer AssociatesRecruiting
  • Karmanos Cancer InstituteRecruiting
  • NYU Langone Health, Perlmutter Cancer Center
  • University of North Carolina Lineberger Comprehensive Cancer Center
  • Carolina BioOncologyRecruiting
  • University of Pennsylvania, Abramson Cancer Center
  • Sarah Cannon Research Institute
  • Next Oncology, DallasRecruiting
  • Next Oncology, San AntonioRecruiting
  • Next Oncology, VirginiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICVB-1042

Arm Description

Part A: Dose escalation Part B: Dose expansion

Outcomes

Primary Outcome Measures

Safety of intravenous ICVB-1042
Assessment of treatment-emergent dose limiting toxicity

Secondary Outcome Measures

Concentration profile of ICVB-1042 in plasma
Determine immunogenicity of ICVB-1042
Assessment of anti-drug antibody titer

Full Information

First Posted
May 23, 2023
Last Updated
September 28, 2023
Sponsor
IconOVir Bio
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1. Study Identification

Unique Protocol Identification Number
NCT05904236
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IconOVir Bio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Advanced Solid Tumors
Keywords
Oncolytic virus, First in human, Relapsed solid tumor, Refractory solid tumor, Tumor biopsy, Novel therapy, Metastatic, Previously treated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Escalating doses
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICVB-1042
Arm Type
Experimental
Arm Description
Part A: Dose escalation Part B: Dose expansion
Intervention Type
Drug
Intervention Name(s)
Treatment with ICVB-1042 administered intravenously
Intervention 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
Primary Outcome Measure Information:
Title
Safety of intravenous ICVB-1042
Description
Assessment of treatment-emergent dose limiting toxicity
Time Frame
From dose administration through 12 weeks
Secondary Outcome Measure Information:
Title
Concentration profile of ICVB-1042 in plasma
Time Frame
Up to 48 hours after drug infusion
Title
Determine immunogenicity of ICVB-1042
Description
Assessment of anti-drug antibody titer
Time Frame
From dose administration through 12 weeks
Other Pre-specified Outcome Measures:
Title
Evaluate shedding of ICVB-1042
Description
ICVB-1042 concentration in urine, feces, and saliva
Time Frame
At study visits from dose administration through 12 weeks
Title
Tumor response by RECIST criteria
Description
Number of patients with complete response, partial response, stable disease or progressive disease will be assessed by tumor imaging
Time Frame
Day 57
Title
Concentration of ICVB-1042 in tumor biopsy
Description
Measurement of ICVB-1042 in biopsy samples
Time Frame
Day 57
Title
Number of patients with immunoreactivity to ICVB-1042 administration
Description
Evaluation of cytokine changes from baseline
Time Frame
At study visits from dose administration through 12 weeks
Title
Number of patients with changes in cell-free tumor DNA
Description
Assessment of tumor DNA in plasma
Time Frame
At study visits on Day 1, Day 10, Day 29, Day 57, Day 85 or Early Termination visit
Title
Evaluate viral replication
Description
Levels of viral proteins in plasma
Time Frame
At study visits from dose administration through 12 weeks
Title
Viral titer of ICVB-1042
Description
Evaluation of infectivity from plasma and saliva samples
Time Frame
At study visits from dose administration through 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IconOVir Study Team
Phone
858 293-5611
Email
CLN01trial@iconovir.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Maltzman, MD
Organizational Affiliation
IconOVir Bio
Official's Role
Study Director
Facility Information:
Facility Name
California Cancer Associates
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
Individual Site Status
Recruiting
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Health, Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of North Carolina Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Carolina BioOncology
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania, Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Next Oncology, Dallas
City
Irving
State/Province
Texas
ZIP/Postal Code
75039
Country
United States
Individual Site Status
Recruiting
Facility Name
Next Oncology, San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Next Oncology, Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Tolerability of Intravenous Administration of ICVB-1042

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