OncoMatch/Clinical Trials/NCT04222413
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Is NCT04222413 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies Metarrestin for advanced solid tumors.
Treatment: Metarrestin — Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs. Objective: To find a safe dose of metarrestin and to see if this dose shrinks tumors. Eligibility: Adults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options. Design: Participants will be screened with: * blood tests * physical exam * documentation of disease confirmation or tumor biopsy * electrocardiogram to evaluate the heart * review of their medicines and their ability to do their normal activities Participants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary. Participants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body. Adult participants may have tumor biopsies. Participants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Pancreatic Cancer
Breast Carcinoma
Colorectal Cancer
Disease stage
Metastatic disease required
Demographics
Prior therapy
Must have received: systemic chemotherapy
progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)
Lab requirements
Blood counts
ANC >= 1.0 x 10^9/L; transfusion-independent platelet count >= 100 x 10^9/L; Hgb >= 9 g/dL (patients who have received <= 2 PRBC transfusions within 48 hours are eligible)
Kidney function
Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl): < 1.5x institution upper limit of normal OR >= 45 mL/min/1.73 m^2 for participant with creatinine levels >= 1.5 X institutional ULN
Liver function
total bilirubin <= 1.5 x ULN (<= 2.0 x ULN in case of prior diagnosis of Gilbert syndrome); AST <= 3xULN; ALT <= 3 xULN
Cardiac function
ECHO <= 53%; LVEF <45%; severe valvular heart disease; atrial fibrillation with ventricular rate >100 bpm at rest; QTcF >= 480 msec (adults) or >= 460 msec (pediatric 12 to <18 years); previous moderate or severe impairment of left ventricular systolic function
Adequate hematological function...Adequate coagulation...Adequate hepatic function...Adequate renal function...cardiomyopathy diagnosed within 6 months prior to treatment initiation including but not limited to the following: hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, abnormal ejection fraction (ECHO <= 53%), previous moderate or severe impairment of left ventricular systolic function (LVEF <45%), severe valvular heart disease, atrial fibrillation with a ventricular rate >100 bpm on EKG at rest, Fridericia's corrected QT interval (QTcF) >= 480 msec (adults) or >= 460 msec (pediatric subjects, aged 12 to <18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Kansas · Fairway, Kansas
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04222413 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic chemotherapy.
Is there an age limit?
Yes. Patients must be 120 years or younger and at least 12 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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