A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ADU-1604, an Anti-CTLA-4 Antibody, in Adults With Metastatic Melanoma
Overview
- Phase
- Phase 1
- Intervention
- ADU-1604
- Conditions
- Metastatic Melanoma
- Sponsor
- Aduro Biotech, Inc.
- Enrollment
- 4
- Locations
- 5
- Primary Endpoint
- Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female aged ≥18 years
- •Histologically-confirmed metastatic or unresectable melanoma
- •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
- •Measurable disease according to RECIST (v1.1) \[NOT required during Dose Escalation\]
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria
- •Prior diagnosis of uveal or mucosal melanoma
- •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.
Arms & Interventions
ADU-1604
ADU-1604 administered as an IV infusion
Intervention: ADU-1604
Outcomes
Primary Outcomes
Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion
Time Frame: 9 months