Safety and Tolerability of Intravenous Administration of ICVB-1042

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 to evaluate the safety and tolerability of intravenous ICVB-1042

Study Overview

• Status: Recruiting
• Conditions: Patients With Advanced Solid Tumors
• Intervention / Treatment: Drug: Treatment with ICVB-1042 administered intravenously

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: IconOVir Study Team; Phone Number: 858 293-5611; Email: CLN01trial@iconovir.com

Study Locations

• United States
  • California
    • San Marcos, California, United States, 92069
      • Recruiting
      • California Cancer Associates
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Institute
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health, Perlmutter Cancer Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Not yet recruiting
      • University of North Carolina Lineberger Comprehensive Cancer Center
    • Huntersville, North Carolina, United States, 28078
      • Recruiting
      • Carolina BioOncology
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Not yet recruiting
      • University of Pennsylvania, Abramson Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Not yet recruiting
      • Sarah Cannon Research Institute
  • Texas
    • Irving, Texas, United States, 75039
      • Recruiting
      • NEXT Oncology, Dallas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Next Oncology, San Antonio
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Oncology, Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICVB-1042; Part A: Dose escalation Part B: Dose expansion	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of intravenous ICVB-1042	Assessment of treatment-emergent dose limiting toxicity	From dose administration through 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration profile of ICVB-1042 in plasma		Up to 48 hours after drug infusion
Determine immunogenicity of ICVB-1042	Assessment of anti-drug antibody titer	From dose administration through 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate shedding of ICVB-1042	ICVB-1042 concentration in urine, feces, and saliva	At study visits from dose administration through 12 weeks
Tumor response by RECIST criteria	Number of patients with complete response, partial response, stable disease or progressive disease will be assessed by tumor imaging	Day 57
Concentration of ICVB-1042 in tumor biopsy	Measurement of ICVB-1042 in biopsy samples	Day 57
Number of patients with immunoreactivity to ICVB-1042 administration	Evaluation of cytokine changes from baseline	At study visits from dose administration through 12 weeks
Number of patients with changes in cell-free tumor DNA	Assessment of tumor DNA in plasma	At study visits on Day 1, Day 10, Day 29, Day 57, Day 85 or Early Termination visit
Evaluate viral replication	Levels of viral proteins in plasma	At study visits from dose administration through 12 weeks
Viral titer of ICVB-1042	Evaluation of infectivity from plasma and saliva samples	At study visits from dose administration through 12 weeks

Collaborators and Investigators

• Sponsor: IconOVir Bio
• Investigators: Study Director: Julie Maltzman, MD, IconOVir Bio

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 6, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Metastatic; Previously treated; Oncolytic virus; Tumor biopsy; First in human; Refractory solid tumor; Relapsed solid tumor; Novel therapy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 1042-CLN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No