NCT07444606

Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical research study is to find the recommended dose level and recommended number of injections of the study agent DNX-2401 that can be given to patients with metastatic melanoma that have intracranial and/or extracranial lesions.

Detailed description

Primary Objectives: Group A: • To determine the safety and tolerability of DNX-2401, a conditionally replication-competent adenovirus (AdV), administered to intracranial lesions in patients with metastatic melanoma as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. (Appendix 2) with evidence of stable extracranial disease, according to RECIST v1.1 criteria, while on immunotherapy. Group B: • To determine the safety and tolerability of DNX-2401, a conditionally replication-competent adenovirus (AdV), administered to extracranial lesions in patients with metastatic melanoma as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. (Appendix 2) with evidence of extracranial disease progression, according to RECIST v1.1 criteria, while on immunotherapy." Secondary Objectives: (All Cohorts) * To evaluate the overall safety profile of DNX-2401 injected into melanoma metastases. * To evaluate antitumor activity of DNX-2401. Exploratory Objective (Window of Opportunity Cohort) • Correlative analysis of intracranial and extracranial tissue to understand immunologic features associated with response and resistance to treatment with DNX-2401. Exploratory Objectives (All Cohorts) * To evaluate the utilization of steroids for symptomatic intracranial metastases during the course of DNX-2401 treatment * To evaluate functional outcomes following DNX-2401 treatment * To differentiate between systemic and intracranial treatment response * To evaluate for imaging evidence of immune mediated treatment response

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	DNX-2401	Given by injection

Timeline

• Start date: 2026-08-31
• Primary completion: 2027-01-30
• Completion: 2029-01-01
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study