Safety of ADU-1604 in Adults With Metastatic Melanoma

• Status: Terminated
• Trial end date: 2019-08-09
• Target enrollment: 0
• Participant gender: All

Summary

This study is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, PK, and PD of ADU-1604 and explore initial clinical activity in adults with metastatic melanoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aduro Biotech, Inc.

Criteria

Inclusion Criteria:

1. Male or female aged ≥18 years

2. Histologically-confirmed metastatic or unresectable melanoma

3. Progression of disease following at least one prior therapy, and is not a candidate for, or is intolerant to, established therapy known to provide clinical benefit (i.e. available treatment options have been exhausted). Subjects must have BRAF mutation status confirmed; if a subject is BRAF V600E/K positive, they must have received a BRAF- targeted regimen prior to entering the study, unless the patient was deemed ineligible for such treatment

4. Measurable disease according to RECIST (v1.1) [NOT required during Dose Escalation]

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

1. Prior diagnosis of uveal or mucosal melanoma

2. Prior treatment with CTLA-4-directed therapy in the metastatic setting. Use of CTLA- 4-directed treatment in the adjuvant or neoadjuvant setting is acceptable provided the last dose was >6 months before the first dose of ADU-1604 and there was no discontinuation of treatment due to a treatment-related toxicity.