Safety of ADU-1604 in Adults With Metastatic Melanoma

NCT03674502 | Terminated Phase 1 DMC

• 1 other identifier: ADU-CL-17
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 5

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.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion

  9 months

Study Arms (1)

ADU-1604

EXPERIMENTAL

ADU-1604 administered as an IV infusion

Drug: ADU-1604

Interventions

ADU-1604 DRUG

anti-CTLA-4 monoclonal antibody

ADU-1604

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aduro Biotech, Inc.: lead

Study Sites (5)

Hôpital de la Timone

Marseille, 13885, France

Location

Hospital Saint Louis

Paris, 75010, France

Location

Gustave- Roussy Institute

Villejuif, 94805, France

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm study

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 17, 2018
• Study Start: November 8, 2018
• Primary Completion: August 9, 2019
• Study Completion: August 9, 2019
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); FR (3)