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Safety of ADU-1604 in Adults With Metastatic Melanoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT03674502•Aduro Biotech, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (5)

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

Seville, Spain

Key Dates

Start Date

November 8, 2018

Primary Completion Date

August 9, 2019

Completion Date

August 9, 2019

Last Updated

May 26, 2020

Enrollment

ACTUAL participants

Conditions

Metastatic Melanoma

Interventions

ADU-1604

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 26, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety of ADU-1604 in Adults With Metastatic Melanoma

Inclusion Criteria

Exclusion Criteria

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