Safety and Tolerability of Intravenous Administration of ICVB-1042

Last updated: April 4, 2025
Sponsor: IconOVir Bio
Overall Status: Terminated

Phase

1

Condition

Neoplasms

Treatment

Treatment with ICVB-1042 administered intravenously

Clinical Study ID

NCT05904236
1042-CLN01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with relapsed or refractory locally advanced or metastatic solidtumors who have progressed on or after at least one prior line of standard of caretherapy including immune checkpoint inhibitors and targeted therapies for knownmolecular alterations if present

  • Measurable disease according to RECIST v1.1

  • ECOG Performance Status 0 or 1

  • Life expectancy of at least 3 months

Exclusion

Exclusion Criteria:

  • Prior SOC or other treatment with a biologic (eg, mAb) within 28 days prior todosing 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 andclinically 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 antifungaltherapy

  • 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

Study Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: Treatment with ICVB-1042 administered intravenously
Phase: 1
Study Start date:
June 01, 2023
Estimated Completion Date:
December 20, 2024

Connect with a study center

  • California Cancer Associates

    San Marcos, California 92069
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • NYU Langone Health, Perlmutter Cancer Center

    New York, New York 10016
    United States

    Site Not Available

  • University of North Carolina Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Carolina BioOncology

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Next Oncology, Dallas

    Irving, Texas 75039
    United States

    Site Not Available

  • Next Oncology, San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Next Oncology, Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

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