Patients With Advanced Solid Tumors
Conditions
Keywords
Oncolytic virus, First in human, Relapsed solid tumor, Refractory solid tumor, Tumor biopsy, Novel therapy, Metastatic, Previously treated
Brief summary
Study to evaluate the safety and tolerability of intravenous ICVB-1042
Interventions
DRUGTreatment 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
Sponsors
IconOVir Bio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Escalating doses
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of intravenous ICVB-1042 | From dose administration through 12 weeks | Assessment of treatment-emergent dose limiting toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Assessment of anti-drug antibody titer |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tumor response by RECIST criteria | Day 57 | Number of patients with complete response, partial response, stable disease or progressive disease will be assessed by tumor imaging |
| Number of patients with changes in cell-free tumor DNA | At study visits on Day 1, Day 10, Day 29, Day 57, Day 85 or Early Termination visit | Assessment of tumor DNA in plasma |
| Concentration of ICVB-1042 in tumor biopsy | Day 57 | Measurement of ICVB-1042 in biopsy samples |
| Viral titer of ICVB-1042 | At study visits from dose administration through 12 weeks | Evaluation of infectivity from plasma and saliva samples |
| Evaluate viral replication | At study visits from dose administration through 12 weeks | Levels of viral proteins in plasma |
| Number of patients with immunoreactivity to ICVB-1042 administration | At study visits from dose administration through 12 weeks | Evaluation of cytokine changes from baseline |
| Evaluate shedding of ICVB-1042 | At study visits from dose administration through 12 weeks | ICVB-1042 concentration in urine, feces, and saliva |
Countries
United States
Outcome results
None listed