MW151 and Whole-brain Radiotherapy in Patients With Intracranial Metastases

NCT05417282 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: MW151-102R44CA236382
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

HYPOTHESIS: MW151 intervention during whole-brain radiotherapy for intracranial metastases is safe and well tolerated 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 evaluated whether MW151 was safe and well tolerated and whether it mitigated neurocognitive decline following whole-brain radiotherapy in adult patients with intracranial metastases from solid tumors.

Conditions

Cognitive Dysfunction, Cognitive Disorder

Keywords

MW151, MW01-2-151SRM, whole brain radiation therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  To assess the safety and tolerability of oral administration of MW151 in adult patients with brain metastases.

  28 days

Secondary Outcomes (3)

• Reduction in Cognitive Deterioration

  6 months

• Progression-free Survival and Overall Survival

  6 months

• Anti-inflammatory Effects

  6 months

Study Arms (1)

Safety and tolerability evaluation

EXPERIMENTAL

Part A, Open-label sentinel cohort: 10 subjects will receive MW151 in an open-label safety and tolerability evaluation. Part B, open-label main cohort. 30 subjects will receive MW151 in an open-label safety and tolerability evaluation.

Drug: MW151

Interventions

MW151 DRUG

Females: 20 mg MW151 daily (10 mg capsule BID), for 28 days; Males: 10 mg MW151 daily (10 mg capsule QD), for 28 days.

Also known as: MW01-2-151SRM

Safety and tolerability evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be willing to and have the capacity to give written informed consent and have signed and dated the informed consent form (ICF) in accordance with ICH and GCP guidelines, as an assurance that all participants understand the risks and benefits of the study
• All patients must be able to speak and understand English proficiently
• Histologically or cytologically confirmed diagnosis of a solid tumor malignancy within the past 5 years
• a. If the original histologic proof of malignancy is \> 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)
• Intracranial metastases (either parenchymal brain metastases or leptomeningeal disease (LMD, also known as neoplastic meningitis, leptomeningeal carcinomatosis, or carcinomatous meningitis)) must be visible on contrast-enhanced MRI

You may not qualify if:

• Subject is lactating or is pregnant
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• Intractable seizures while on adequate anticonvulsant therapy (i.e., more than one seizure per month for the past 2 months)
• Clinically significant abnormalities in screening laboratory tests that would affect patient safety as determined by the principal investigator
• History of psychiatric disorder requiring ongoing medical management
• History of substance abuse including alcohol within past 5 years Appropriately prescribed medication for the treatment of pain or other symptoms related to the underlying malignancy is acceptable
• Chronic kidney disease defined as the presence of significant proteinuria on urinalysis and/or eGFR of \<60mL/min, as calculated by the clinical site laboratory
• Inability to follow the instructions or an unwillingness to cooperate with study procedures
• Known allergy to any component of MW151 as described in investigator's brochure
• Received treatment with and/or planned treatment with systemic chemotherapy within 3 days prior, during, or for at least 3 days after completion of whole-brain radiotherapy. Concurrent immunotherapy is permitted

Sponsors & Collaborators

• ImmunoChem Therapeutics, LLC: lead
• National Cancer Institute (NCI): collaborator
• Northwestern Medicine: collaborator

Study Sites (1)

Northwestern Memorial HealthCare, Central DuPage Hospital, Warrenville Cancer Center

Winfield, Illinois, 60555, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

2-(4-(4-methyl-6-phenylpyridazin-3-yl)piperazin-1-yl)pyrimidine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Part B was originally designed as a randomized, placebo-controlled cohort enrolling 30 subjects, with subjects randomized 1:1 to MW151 or placebo. Due to slow recruitment in Part A, the protocol was amended to convert Part B to an open-label design. Male and female subjects were analyzed together because the sex-specific dosing regimen was part of the protocol-defined MW151 treatment strategy and did not constitute separate treatment arms.

Results Point of Contact

• Title: Victor Shifrin, CEO
• Organization: ImmunoChem Therapeutics, LLC

vshifrin@ic-rx.com

6178720639

Study Officials

• Vinai Gondi, MD

  Northwestern Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 14, 2022
• Study Start: July 1, 2022
• Primary Completion: June 11, 2025
• Study Completion: July 31, 2025
• Last Updated: August 31, 2026
• Results First Posted: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)