Safety of ADU-1604 in Adults With Metastatic Melanoma

Metastatic Melanoma Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ADU-1604, an Anti-CTLA-4 Antibody, in Adults With Metastatic Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03674502
• Other study ID #: ADU-CL-17
• Status: Terminated
• Phase: Phase 1
• Start date: November 8, 2018
• Est. completion date: August 9, 2019

Study information

• Verified date: May 2020
• Source: Aduro Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 9, 2019
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• ADU-1604
anti-CTLA-4 monoclonal antibody

Locations

Country	Name	City	State
France	Hôpital de la Timone	Marseille
France	Hospital Saint Louis	Paris
France	Gustave- Roussy Institute	Villejuif
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Virgen Macarena	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Aduro Biotech, Inc.

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion		9 months