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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07444606
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DNX-2401 — DRUG
    Given by injection

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Apr 2026
Primary completion
Jan 30, 2027
Completion
Jan 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GroupA-Arm1: IC virus delivery followed by surgical resection
    Participants will receive 1 injection of DNX-2401.
  • Experimental: Group A-Arm 2: DL1, DL2, DL3
    Participants in Group A Arm 2, you will receive DNX-2401 at the recommended dose that was found in Group A Arm 1, and you will receive up to 3 injections of DNX-2401 into the selected brain lesion.
  • Experimental: Group B: Patients with either EC or EC and IC disease
    Participants in Group B, you will receive up to 6 injections of DNX-2401.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Christopher Alvarez-Breckenridge, MD, PHD
[email protected]
713-792-2400
Christopher Alvarez-Breckenridge, MD, PHD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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