Clinical trial · Interventional
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
NCT05904236CI-TRIAL-00088269ICVB-1042terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of Demonstrated Clinical Activity
Summary
Brief summary (as posted)
Study to evaluate the safety and tolerability of intravenous ICVB-1042
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment with ICVB-1042 administered intravenously | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICVB-1042
- description
- Part A: Dose escalation Part B: Dose expansion
- interventionNames
- Drug: Treatment with ICVB-1042 administered intravenously
Primary outcomes (1)
- measure
- Safety of intravenous ICVB-1042
- timeFrame
- From dose administration through 12 weeks
- description
- Assessment of treatment-emergent dose limiting toxicity
Secondary outcomes (2)
- measure
- Concentration profile of ICVB-1042 in plasma
- timeFrame
- Up to 48 hours after drug infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKato 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