A 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

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

Secondary Objectives:

Eligibility

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

Locations

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Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices