Clinical trial · Interventional
Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers (PSX-X04)
A Phase I, Open-Label, Cohort Study of Multiple Doses of Cavatak™ (Coxsackie Virus A21) Given Intravenously to Stage IV Solid Tumour Cancer Patients Bearing ICAM-1 With or Without DAF Expressing Tumours (PSX-X04)
NCT00636558CI-TRIAL-00039275PSX-X04completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Coxsackie A21 (CVA21) virus is to be administered by IV infusion to patients with Stage 4 melanoma, prostate and breast cancer. This is a dose escalation, safety study.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CVA21 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CVA21
- description
- IV administration of CVA21 in a dose escalation manner
- interventionNames
- Drug: CVA21
Primary outcomes (1)
- measure
- The primary objective of the study is to determine the safety and tolerability of CVA21 given by intravenous infusion in multiple escalating doses.
- timeFrame
- Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
Secondary outcomes (2)
- measure
- To obtain preliminary efficacy data, determine the time course of viraemia and its elimination post-administration of CVA21
- timeFrame
- Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who are willing and able to provide written informed consent to participate in the study. 2. Male or female aged 18 years or older. 3. Stage IV solid tumour disease with the primary tumour being any one of the following types - breast, prostate or melanoma. 4. ICAM-1 with or without DAF-expressing tumour. Patients without archival material for testing must agree to a new tumour biopsy. 5. Absence of circulating antibodies to CVA21 (titre \< 1:16). 6. Patients must have failed or refused standard treatment(s). 7. Adequate haematological, hepatic and renal function, defined as: * ANC \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L * Bilirubin \< 20µmol/L, AST \< 2.5 times the upper limit of normal * Calculated creatinine clearance \> 30 mL/minute 8. Adequate immunologic function, defined as: * Serum IgG \> 5g/L * T cell subsets within normal limits 9. Fertile males and females must agree to the use of an adequate form of contraception. Hormonal contraceptives should be supplemented with an additional barrier method. Negative pregnancy test is required in female patients of child-bearing potential. Exclusion Criteria: 1. Presence or history of Central Nervous System (CNS) malignancy. 2. Patients must not have received chemotherapy within 4 weeks prior to date of consent. 3. Performance status \> 1 on the Eastern Cooperative Oncology Group (ECOG) scale. 4. Life expectancy \< 6 months. 5. Pregnancy or breastfeeding. 6. Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g. prednisolone \> 7.5mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks. 7. Positive serology for HIV, hepatitis B or hepatitis C. 8. Splenectomy. 9. Presence of uncontrolled infection. 10. Presence of unstable neurological disease. 11. Any uncontrolled medical condition that in the opinion of the Investigator is likely to place the patient at unacceptable risk during the study or reduce their ability to complete the study 12. Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks 13. Known allergy to treatment medication or its excipients 14. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.