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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
anti-CTLA-4 monoclonal antibody
Hôpital de la Timone
Marseille, France
Hospital Saint Louis
Paris, France
Gustave- Roussy Institute
Villejuif, France
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitario Virgen Macarena
Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion
Time frame: 9 months
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Seville, Spain