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Report for Clinical Trial NCT03674502

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT03674502 Metastatic Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

1 Interventions

Name: ADU-1604

Description: anti-CTLA-4 monoclonal antibody
Type: Drug
Group Labels: 1

ADU-1604


Primary Outcomes

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

Time: 9 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

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. --- V600E ---



HPO Nodes


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