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Safety of ADU-1604 in Adults With Metastatic Melanoma

Primary Purpose

Metastatic Melanoma

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ADU-1604
Sponsored by
Aduro Biotech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hôpital de la Timone
  • Hospital Saint Louis
  • Gustave- Roussy Institute
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario Virgen Macarena

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADU-1604

Arm Description

ADU-1604 administered as an IV infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 11, 2018
Last Updated
May 22, 2020
Sponsor
Aduro Biotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03674502
Brief Title
Safety of ADU-1604 in Adults With Metastatic Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to business realignment
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
August 9, 2019 (Actual)
Study Completion Date
August 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aduro Biotech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADU-1604
Arm Type
Experimental
Arm Description
ADU-1604 administered as an IV infusion
Intervention Type
Drug
Intervention Name(s)
ADU-1604
Intervention Description
anti-CTLA-4 monoclonal antibody
Primary Outcome Measure Information:
Title
Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13885
Country
France
Facility Name
Hospital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Gustave- Roussy Institute
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Seville
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety of ADU-1604 in Adults With Metastatic Melanoma

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