Trial Outcomes & Findings for MW151 and Whole-brain Radiotherapy in Patients With Intracranial Metastases (NCT NCT05417282)
NCT ID: NCT05417282
Last Updated: 2026-08-31
Results Overview
To assess the safety and tolerability of oral administration of MW151 in adult patients with brain metastases.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
28 days
Results posted on
2026-08-31
Participant Flow
The study was initiated on July 1, 2022, and the last follow-up visit was completed on June 11, 2025.
A total of 27 subjects were screened, and 24 subjects were enrolled. One enrolled subject refused treatment; therefore, 23 subjects received open-label MW151 and were included in the Safety Population. Male (10 mg MW151/day) and female (20 mg MW151/day) 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.
Participant milestones
| Measure |
Part A, Open-label Sentinel Cohort + Part B, Open-label Main Cohort
In Part A, the sentinel cohort, 10 participants received MW151 for safety and tolerability evaluation. In Part B, the main cohort, 13 participants received MW151 for safety and tolerability evaluation. All 23 treated subjects were analyzed as a single cohort.
Male subjects received MW151 10 mg once daily, whereas female subjects received MW151 10 mg twice daily. These dosing regimens were selected to provide appropriate MW151 exposure by sex and were implemented within the same open-label treatment cohort.
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.
The study was a feasibility trial designed primarily to evaluate safety, tolerability, and exploratory neurocognitive outcomes, and it was not powered to compare outcomes between male and female subjects or between dose levels. In addition, all treated subjects received active MW151, there was no placebo or untreated comparator group, and the overall Safety Population was small. Therefore, separating subjects by sex/dose would have produced very small subgroups with limited interpretability.
Accordingly, all subjects who received MW151 were analyzed as a single Safety Population. Sex-specific dosing is described in the dosing section, and sex is summarized as a baseline demographic characteristic, but safety and efficacy summaries are presented for the combined treated population.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Part A, Open-label Sentinel Cohort + Part B, Open-label Main Cohort
In Part A, the sentinel cohort, 10 participants received MW151 for safety and tolerability evaluation. In Part B, the main cohort, 13 participants received MW151 for safety and tolerability evaluation. All 23 treated subjects were analyzed as a single cohort.
Male subjects received MW151 10 mg once daily, whereas female subjects received MW151 10 mg twice daily. These dosing regimens were selected to provide appropriate MW151 exposure by sex and were implemented within the same open-label treatment cohort.
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.
The study was a feasibility trial designed primarily to evaluate safety, tolerability, and exploratory neurocognitive outcomes, and it was not powered to compare outcomes between male and female subjects or between dose levels. In addition, all treated subjects received active MW151, there was no placebo or untreated comparator group, and the overall Safety Population was small. Therefore, separating subjects by sex/dose would have produced very small subgroups with limited interpretability.
Accordingly, all subjects who received MW151 were analyzed as a single Safety Population. Sex-specific dosing is described in the dosing section, and sex is summarized as a baseline demographic characteristic, but safety and efficacy summaries are presented for the combined treated population.
|
|---|---|
|
Overall Study
Death
|
9
|
|
Overall Study
Disease progression and hospice transfer
|
2
|
|
Overall Study
Sponsor decision due to trial termination
|
3
|
Baseline Characteristics
MW151 and Whole-brain Radiotherapy in Patients With Intracranial Metastases
Baseline characteristics by cohort
| Measure |
Part A, Open-label Sentinel Cohort + Part B, Open-label Main Cohort
n=23 Participants
In Part A, the sentinel cohort, 10 participants received MW151 for safety and tolerability evaluation. In Part B, the main cohort, 13 participants received MW151 for safety and tolerability evaluation. All 23 treated subjects were analyzed as a single cohort.
Male and female subjects were combined for analysis because the sex-specific MW151 doses were protocol-defined regimens within the same open-label treatment cohort, not separate treatment arms. The study was a small feasibility trial designed to evaluate overall safety, tolerability, and exploratory neurocognitive outcomes and was not powered for sex- or dose-based comparisons. Because all treated subjects received MW151 and no comparator group was included, all treated subjects were analyzed as a single Safety Population.
|
|---|---|
|
Age, Continuous
|
59.65 year
STANDARD_DEVIATION 13.07 • n=14 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: A total of 27 subjects were screened, and 24 subjects were enrolled. One enrolled subject refused treatment; therefore, 23 subjects received open-label MW151 and were included in the Safety Population. Because both study cohorts received MW151 and there was no comparator group, all treated subjects were analyzed as a single cohort.
To assess the safety and tolerability of oral administration of MW151 in adult patients with brain metastases.
Outcome measures
| Measure |
Safety Population
n=23 Participants
All participants who received at least one dose of MW151
|
|---|---|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Participants with any TEAE leading to death
|
9 Participants
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Participants with any TEAE leading to study drug discontinuation
|
1 Participants
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Participants with any serious adverse event (SAE)
|
15 Participants
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Participants with any treatment-related TEAE
|
7 Participants
|
|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Participants with any Grade >=3 TEAE
|
16 Participants
|
SECONDARY outcome
Timeframe: 6 monthsTo determine if the addition of MW151 to WBRT standard of care treatment will show a trend towards reduction in cognitive deterioration in patients with brain metastases from solid tumors, as measured by standardized NCF tests.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsTo evaluate intracranial progression-free survival and overall survival following the addition of MW151 to WBRT standard of care treatment for patients with brain metastases.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsTo determine if the addition of MW151 to WBRT will have an impact on plasma levels of proinflammatory cytokines (PIC).
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: 6 monthsTo correlate the difference between brain age over time with neurocognitive function following whole-brain radiotherapy plus MW151 using SBDL (Surface-Based Deep Learning) brain age prediction.
Outcome measures
Outcome data not reported
Adverse Events
Safety Population
Serious events: 15 serious events
Other events: 23 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Safety Population
n=23 participants at risk
All participants who received at least one dose of MW151.
Male and female subjects were combined for analysis because the sex-specific MW151 doses were protocol-defined regimens within the same open-label treatment cohort, not separate treatment arms. The study was a small feasibility trial designed to evaluate overall safety, tolerability, and exploratory neurocognitive outcomes and was not powered for sex- or dose-based comparisons. Because all treated subjects received MW151 and no comparator group was included, all treated subjects were analyzed as a single Safety Population.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Endocrine disorders
Adrenal insufficiency
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
8.7%
2/23 • Number of events 2 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Psychiatric disorders
Confusional state
|
8.7%
2/23 • Number of events 2 • From enrollment until end of follow-up, up to 24 weeks
|
|
Infections and infestations
COVID-19
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Psychiatric disorders
Delirium
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Encephalopathy
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Metabolism and nutrition disorders
Failure to thrive
|
8.7%
2/23 • Number of events 2 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.7%
2/23 • Number of events 2 • From enrollment until end of follow-up, up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Loss of consciousness
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Malignant airway obstruction
|
4.3%
1/23 • Number of events 3 • From enrollment until end of follow-up, up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
8.7%
2/23 • Number of events 2 • From enrollment until end of follow-up, up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Gastrointestinal disorders
Oesophageal compression
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.7%
2/23 • Number of events 2 • From enrollment until end of follow-up, up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
General disorders and administration site conditions
Pyrexia
|
8.7%
2/23 • Number of events 2 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Seizure
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
General disorders and administration site conditions
Systemic inflammatory response syndrome
|
4.3%
1/23 • Number of events 1 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Toxic encephalopathy
|
8.7%
2/23 • Number of events 2 • From enrollment until end of follow-up, up to 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • Number of events 2 • From enrollment until end of follow-up, up to 24 weeks
|
Other adverse events
| Measure |
Safety Population
n=23 participants at risk
All participants who received at least one dose of MW151.
Male and female subjects were combined for analysis because the sex-specific MW151 doses were protocol-defined regimens within the same open-label treatment cohort, not separate treatment arms. The study was a small feasibility trial designed to evaluate overall safety, tolerability, and exploratory neurocognitive outcomes and was not powered for sex- or dose-based comparisons. Because all treated subjects received MW151 and no comparator group was included, all treated subjects were analyzed as a single Safety Population.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
17.4%
4/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Aphasia
|
17.4%
4/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Balance disorder
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Dizziness
|
21.7%
5/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Dysgeusia
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Headache
|
43.5%
10/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Hemiparesis
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Nervous system disorders
Seizure
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Psychiatric disorders
Agitation
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Psychiatric disorders
Confusional state
|
17.4%
4/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Psychiatric disorders
Depression
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.4%
4/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.5%
10/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Vascular disorders
Hypertension
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Endocrine disorders
Adrenal insufficiency
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Endocrine disorders
Androgen deficiency
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Endocrine disorders
Hypothyroidism
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Eye disorders
Vision blurred
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
47.8%
11/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
34.8%
8/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
General disorders
Asthenia
|
17.4%
4/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
General disorders
Chest discomfort
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
General disorders
Fatigue
|
69.6%
16/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
General disorders
Gait disturbance
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
General disorders
Oedema peripheral
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Immune system disorders
Drug hypersensitivity
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Infections and infestations
Candida infection
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Infections and infestations
Sepsis
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
17.4%
4/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
21.7%
5/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Investigations
Blood testosterone decreased
|
21.7%
5/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Investigations
Blood triglycerides increased
|
17.4%
4/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Investigations
Lymphocyte count decreased
|
17.4%
4/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Metabolism and nutrition disorders
Failure to thrive
|
8.7%
2/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.4%
4/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.0%
3/23 • From enrollment until end of follow-up, up to 24 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
21.7%
5/23 • From enrollment until end of follow-up, up to 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60