MW151 and HA-WBRT in Patients With Brain Metastases (MW151-102)

  • STATUS
    Recruiting
  • End date
    Aug 14, 2024
  • participants needed
    40
  • sponsor
    ImmunoChem Therapeutics, LLC
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Updated on 4 October 2022
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Summary

HYPOTHESIS: MW151 intervention will attenuate radiation induced cognitive impairment caused by hippocampal-avoidant whole brain radiation therapy (HA-WBRT) for brain metastases.

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 MW151 as a mitigator of cognitive dysfunction caused by HA-WBRT in adult patients with brain metastases from solid tumors, as compared with a control group of patients receiving HA-WBRT and placebo.

Description

In Part A, 10 subjects will receive MW151 in an open label evaluation. At least 5 of these subjects will be male. For each subject, safety and tolerability data for the first 24 hours will be reviewed prior to the continuation of dosing. Subjects will also be evaluated for safety during week 1, during week 2, and at week 4. Once the data from Part A have been reviewed by the Safety Monitoring Committee (SMC), an additional 30 subjects will be recruited to Part B. These subjects will be randomly assigned to MW151 or placebo in a 1:1 ratio.

In both parts A and B subjects will take study drug (males), or the first daily dose of study drug (females) before HA-WBRT which will be administered once a day (3Gy), five days a week (Monday to Friday) for two weeks, for total of ten treatments and 30 Gy.

Details
Condition Cognitive Dysfunction, Cognitive Disorder
Treatment MW151
Clinical Study IdentifierNCT05417282
SponsorImmunoChem Therapeutics, LLC
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

A subject will be eligible for inclusion in the study only if all of the following criteria are met
All patients must be willing to and have the capacity to give written informed consent and have signed and dated the informed consent form in accordance with ICH and GCP guidelines
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
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)
Brain metastases must be visible on contrast-enhanced MRI
Patients who had undergone radiosurgery or surgical resection and are planning adjuvant HA-WBRT do not have to have visible disease but do need a baseline MRI
Karnofsky performance status 70-100%
Serum creatinine ≤ 3 mg/dL and creatinine clearance ≥ 30 mL/min as determined by Cockcroft-Gault
Negative urine pregnancy test within 14 days of Day 1 for Women of Childbearing Potential
Women of childbearing potential and men with female partners of childbearing potential must have no plans for further conception and must practice adequate contraception

Exclusion Criteria

A subject will not be eligible for inclusion in the study if any of the following
criteria are met
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 or placebo 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 HA-WBRT
Concurrent immunotherapy is permitted
Prior whole-brain radiotherapy
Use of chronic short-acting benzodiazepine
Use of NSAIDS or steroids within 3 days prior to dosing
Any reason or opinion of the investigator that would prevent the subject from participation in the study
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