drugset / Trial / NCT04416516

Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor

NCT04416516

Phase 2 Completed 21 enrolled Ascend Biopharmaceuticals Ltd
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objectives are to: 1. Evaluate the safety and tolerability of intralesional ASN-002 when administered in combination with oral vismodegib in patients with Basal Cell Carcinomas (BCC)s; 2. Evaluate the efficacy of intralesional ASN-002 in target tumours when administered in combination with oral vismodegib in patients with BCCs. The secondary objective is to: 1\) Evaluate the efficacy of intralesional ASN-002 in non-target tumours when administered in combination with oral vismodegib in patients with BCCs. The exploratory objective is to: 1\) Evaluate immunological biomarkers during the course of treatment.

Timeline

Start
2020-07-16
Primary completion
2024-02-14
Completion
2024-02-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Gusacitinib Small molecule 5e+10 unknown Other
Subject Gusacitinib Small molecule 1e+11 unknown Other
Subject Gusacitinib Small molecule 1.5e+11 unknown Other