Clinical trial · Interventional
A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma
A Phase 1/2a Study of the Efficacy and Safety of ASN-002 Alone or in Combination With 5-FU in Adult Patients With Low-risk Nodular Basal Cell Carcinoma
NCT02550678CI-TRIAL-00033193ASN-002-001completedPhase 1 / Phase 2ClinicalTrials.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)
The study evaluates whether ASN-002 is safe and effective in the treatment of nodular basal cell carcinoma (nBCC) in patients aged 18 years or over. The participants will receive weekly injections of ASN-002 alone or in combination with 5-FU for 3 weeks and undergo surgical excision of the tumor.
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 |
|---|---|---|---|
| Basal Cell Nevus Syndrome | — | UNRESOLVED | — |
| Nodular Basal Cell Carcinoma of Skin | Skin Nodular Basal Cell Carcinoma | ALIAS | 0.90 |
| Skin Neoplasm | Skin Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| ASN-002 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Study Participants will receive ASN-002 at a dose 5X 10(10) vp, weekly injection in tumor nodules for 3 weeks.
- interventionNames
- Biological: ASN-002
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Study Participants will receive ASN-002 at a dose of 1.5X 10(11) vp weekly injection in tumor nodules for 3 weeks
- interventionNames
- Biological: ASN-002
- type
- EXPERIMENTAL
- label
- Cohort 4
- description
- Study Participants will receive ASN- 002 at a dose of 3.0X 10(11) vp weekly injections in tumor nodules for 3 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Low risk nodular basal cell carcinoma 2. Biopsy of any other skin tumor 3. Willingness to have injection therapy followed by surgery 4. Written informed consent Exclusion Criteria: 1. No or only minimal symptoms 2. Known or suspected metastatic disease. 3. Pregnant or Lactating females 4. Clinically active or uncontrolled skin disease 5. Immunocompromised or receiving immunomodulating agent 6. treatment with psoralen plus Ultraviolet A or Ultraviolet B light therapy within 6 months 7. Any serious or active medical or psychiatric illness 8. Recreational or therapeutic drug or alcohol use 9. Taking any investigational product within 1 month of first dose of ASN- 002.
References
Publications (0)
Data not yet available
No reference posted for this study.