Safety and Tolerability of Intravenous Administration of ICVB-1042

NCT05904236 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 1042-CLN01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 10

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Safety of intravenous ICVB-1042

  Assessment of treatment-emergent dose limiting toxicity

  From dose administration through 12 weeks

Secondary Outcomes (2)

• Concentration profile of ICVB-1042 in plasma

  Up to 48 hours after drug infusion

• Determine immunogenicity of ICVB-1042

  From dose administration through 12 weeks

Other Outcomes (7)

• Evaluate shedding of ICVB-1042

  At study visits from dose administration through 12 weeks

• Tumor response by RECIST criteria

  Day 57

• Concentration of ICVB-1042 in tumor biopsy

  Day 57

Study Arms (1)

ICVB-1042

EXPERIMENTAL

Part A: Dose escalation Part B: Dose expansion

Drug: Treatment with ICVB-1042 administered intravenously

Interventions

Treatment with ICVB-1042 administered intravenously 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

ICVB-1042

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IconOVir Bio: lead

Study Sites (10)

California Cancer Associates

San Marcos, California, 92069, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

NYU Langone Health, Perlmutter Cancer Center

New York, New York, 10016, United States

Location

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Carolina BioOncology

Huntersville, North Carolina, 28078, United States

Location

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Next Oncology, Dallas

Irving, Texas, 75039, United States

Location

Next Oncology, San Antonio

San Antonio, Texas, 78229, United States

Location

Next Oncology, Virginia

Fairfax, Virginia, 22031, United States

Location

Related Publications (1)

• 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.

  PMID: 39271928 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Maltzman, MD

  IconOVir Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Escalating doses

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 15, 2023
• Study Start: June 1, 2023
• Primary Completion: December 11, 2024
• Study Completion: December 20, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)