Safety and Tolerability of Intravenous Administration of ICVB-1042

NCT ID: NCT05904236

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-12-20

Brief Summary

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

Conditions

Patients With Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICVB-1042

Part A: Dose escalation Part B: Dose expansion

Group Type: EXPERIMENTAL

Treatment with ICVB-1042 administered intravenously

Intervention Type: DRUG

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

Interventions

Treatment with ICVB-1042 administered intravenously

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IconOVir Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Maltzman, MD

Role: STUDY_DIRECTOR

IconOVir Bio

Locations

California Cancer Associates

San Marcos, California, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

NYU Langone Health, Perlmutter Cancer Center

New York, New York, United States

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Carolina BioOncology

Huntersville, North Carolina, United States

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Next Oncology, Dallas

Irving, Texas, United States

Next Oncology, San Antonio

San Antonio, Texas, United States

Next Oncology, Virginia

Fairfax, Virginia, United States

Countries

United States

References

Kato Y, Rice N, Pokrass M, Jeong J, Rodriguez R, Field JJ, Nowyhed H. Nonclinical characterization of ICVB-1042 as a selective oncolytic adenovirus for solid tumor treatment. Commun Biol. 2024 Sep 13;7(1):1132. doi: 10.1038/s42003-024-06839-6.

Reference Type: DERIVED

PMID: 39271928 (View on PubMed)

Other Identifiers

1042-CLN01

Identifier Type: -

Identifier Source: org_study_id