Safety of ADU-1604 in Adults With Metastatic Melanoma

Phase 1

Terminated

• Conditions: Metastatic Melanoma
• Interventions: Drug: ADU-1604

• Registration Number: NCT03674502
• Lead Sponsor: Aduro Biotech, Inc.

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.

Study Timeline

• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Study Start: 2018-11-08
• Primary Completion: 2019-08-09
• Study Completion: 2019-08-09
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADU-1604	ADU-1604	ADU-1604 administered as an IV infusion

Primary Outcome Measures

Name	Time	Method
Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion	9 months

Trial Locations

Locations (5)

Hospital Universitario Virgen Macarena; 🇪🇸 Seville, Spain

Hôpital de la Timone; 🇫🇷 Marseille, France

Hospital Saint Louis; 🇫🇷 Paris, France

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Gustave- Roussy Institute; 🇫🇷 Villejuif, France