OncoMatch/Clinical Trials/NCT04222413
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Is NCT04222413 recruiting? Yes, currently enrolling (May 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
Cancer type
Tumor Agnostic
Pancreatic Cancer
Breast Carcinoma
Colorectal Cancer
Disease stage
Metastatic disease required
Prior therapy
Must have received: systemic chemotherapy
progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)
Cannot have received: alkylating agent (cyclophosphamide, chlorambucil, melphalan, ifosfamide)
chemotherapy regimen containing an alkylating antineoplastic agent (cyclophosphamide, chlorambucil, melphalan, or ifosfamide)...within 28 days
Cannot have received: alkylating-like agent (platinum-based chemotherapeutic drugs, platinum analogues)
alkylating-like (platinum-based chemotherapeutic drugs, platinum analogues)...within 28 days
Cannot have received: non-classical alkylating agent (dacarbazine, temozolomide)
non-classical alkylating agent (dacarbazine, temozolomide) within 28 days
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 < 1.5x institution ULN OR CrCl/eGFR >= 45 mL/min/1.73 m^2 for participant with creatinine >= 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
QTcF < 480 msec (adults) or < 460 msec (pediatric subjects, aged 12 to <18 years); LVEF >= 45%; ECHO > 53%; no severe valvular heart disease; no atrial fibrillation with ventricular rate >100 bpm at rest
Adequate hematological function...Adequate coagulation...Adequate hepatic function...Adequate renal function...cardiac exclusion criteria
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
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