NCT03674502

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Aduro Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	ADU-1604	anti-CTLA-4 monoclonal antibody

Timeline

• Start date: 2018-11-08
• Primary completion: 2019-08-09
• Completion: 2019-08-09
• First posted: 2018-09-17
• Last updated: 2020-05-26

Locations

5 sites across 2 countries: France, Spain