drugset / Trial / NCT03208296

Study of ASN-002 to Treat Basal Cell Carcinomas (BCCs) in Individuals With Basal Cell Nevus Syndrome (BCNS)

NCT03208296

Phase 1/2 Suspended 24 enrolled Ascend Biopharmaceuticals Ltd
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objective is to confirm the safety of treating multiple BCCs once weekly x 3 weeks in individuals with Basal Cell Nevus Syndrome (BCNS). The secondary objectives of the study are to obtain preliminary data on the effectiveness of ASN-002 in the treatment of BCCs in individuals with Basal Cell Nevus Syndrome (BCNS) by 1. evaluating the histological clearance of BCCs in patients with BCNS, and 2. assessing the clinical changes of BCCs after treatment with ASN-002, and 3. assessing the systemic effect of ASN-002 by determining response in non-injected lesions 4. assess the safety and clinical changes after a second cycle of ASN-002 injections

Timeline

Start
2017-12-01
Primary completion
2024-12-31
Completion
2025-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Gusacitinib Small molecule 1e+11 unknown Other
Subject Gusacitinib Small molecule 1.5e+11 unknown Other

Indications