Safety of ADU-1604 in Adults With Metastatic Melanoma

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ADU-1604, an Anti-CTLA-4 Antibody, in Adults With Metastatic Melanoma

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.

ADU-CL-17 is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ADU-1604, an anti-CTLA-4 monoclonal antibody, and explore initial clinical activity in adults with metastatic melanoma. The primary objective of the study is to determine the Recommended Phase 2 Dose (RP2D) of ADU-1604 administered by IV infusion once every 3 weeks for 4 doses.

The study will be conducted in two parts: Dose Escalation followed by Dose Confirmation.

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.