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VP-315 (Ruxotemitide) in Basal Cell Carcinoma
NCT05188729Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2022
- Primary completion
- Apr 2024
- Countries
- 1
- Sponsor
- Verrica Pharmaceuticals
- Modality
- Peptides
- Drugs
- ruxotemitide
- Conditions
- basal cell carcinoma (BCC)
01
Overview
Phase 2, open-label trial of ruxotemitide in basal cell carcinoma (BCC) (11 cohorts), sponsored by Verrica Pharmaceuticals. Primary endpoints: Percentage of Subjects With Discontinuations Due to Adverse Events up to 15 weeks, Percentage of Subjects With Dose-limiting Toxicities (DLTs) at Day 4 and 3 more. Started Feb 2022; status: completed.
02
Design
11 arms- Study design
- Non-randomizedOpen-label
P1 Cohort 1
2-8mg dose escalation
P1 Cohort 2
3-8mg dose escalation
P1 Cohort 3
4-8mg dose escalation
P1 Cohort 4
5-8mg dose escalation
P1 Cohort 5
6-8mg dose escalation
P1 Cohort 6
7-8mg dose escalation
5 more in the full profile.
03
Who it enrols
Adults with biopsy-proven nodular, micronodular, or superficial BCC with at least 1 eligible target lesion >= 0.5 cm. Excludes high-risk BCC subtypes, Gorlin syndrome, immunosuppressed patients, and those with recent systemic cancer treatment.
04
Endpoints
Primary
Percentage of Subjects With Discontinuations Due to Adverse Events
Percentage of Subjects With Dose-limiting Toxicities (DLTs)
Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Percent of Subjects With Adverse Events
Percent of Subjects With Treatment Related Adverse Events of Special Interest
Secondary
Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Mean Estimated Remaining Tumor Volume at Excision
Plasma Concentrations of VP-315
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