MW151 and Whole-brain Radiotherapy in Patients With Intracranial Metastases
NCT05417282 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2025-10-15
Summary
HYPOTHESIS: MW151 intervention during whole-brain radiotherapy for intracranial metastases is safe and will mitigate neurocognitive decline.
RATIONALE: There is non-clinical evidence that MW151 reduces brain inflammation and improves neurocognitive outcomes in animal models of radiation therapy induced cognitive dysfunction, and in animal models of other CNS disorders.
PURPOSE: This feasibility trial will study whether MW151 mitigates neurocognitive decline following whole-brain radiotherapy in adult patients with intracranial metastases from solid tumors.
Conditions
- Cognitive Dysfunction, Cognitive Disorder
Interventions
- DRUG
-
MW151
Females: 20 mg MW151 daily (10 mg capsule BID), for 28 days; Males: 10 mg MW151 daily (10 mg capsule QD), for 28 days.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - collaborator OTHER
-
ImmunoChem Therapeutics, LLC
lead INDUSTRY
Principal Investigators
-
Vinai Gondi, MD · Northwestern Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-01
- Primary Completion
- 2025-07-31
- Completion
- 2025-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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