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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03674502

Enrollment

Registered

2018-09-17

Start date

2018-11-08

Completion date

2019-08-09

Last updated

2020-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Melanoma

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.

Interventions

DRUGADU-1604

anti-CTLA-4 monoclonal antibody

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single arm study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Countries

France, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026