Safety of ADU-1604 in Adults With Metastatic Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2019-08-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma

NCT03467516

Uveal Neoplasms Melanoma, Uveal

RECRUITING PHASE2

First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma

NCT06797999

Metastatic Soft Tissue Sarcoma Unresectable Soft Tissue Sarcoma

RECRUITING PHASE1/PHASE2

A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients

NCT04501276

Advanced/Metastatic Solid Tumors

COMPLETED PHASE1

TR1801-ADC in Patients With Tumors That Express c-Met

NCT03859752

Unspecified Adult Solid Tumor, Protocol Specific

SUSPENDED PHASE1

Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

NCT04111445

Solid Tumor

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ADU-1604

ADU-1604 administered as an IV infusion

Group Type EXPERIMENTAL

ADU-1604

Intervention Type DRUG

anti-CTLA-4 monoclonal antibody

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADU-1604

anti-CTLA-4 monoclonal antibody

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No