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Metarrestin / Metastatic Pancreatic Cancer / Pediatric Solid Tumor · Phase 1 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 registration for metarrestin (ML-246), a candidate anti-metastatic agent, in adults and adolescents with advanced or metastatic solid tumors. The study is currently recruiting and has not yet reported results; the registered primary outcomes are maximum tolerated dose and objective response rate at MTD.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Advanced Solid Tumors, Metastatic Pancreatic Cancer, Pediatric Solid Tumor, Advanced Breast Cancer, Malignant Peripheral Nerve Sheath Tumor, Colorectal Neoplas…; age from 12 Years; to 120 Years. Intervention: 1/Arm 1; 2/Arm 2. n = 116. 2 sites: United States.
This is a Phase 1 registration for metarrestin (ML-246), a candidate anti-metastatic agent, in adults and adolescents with advanced or metastatic solid tumors. The study is currently recruiting and has not yet reported results; the registered primary outcomes are maximum tolerated dose and objective response rate at MTD.
Registry record contains no outcome data or safety results; study is ongoing. No efficacy comparator or control arm described; primary focus is dose-finding and tolerability.
No clinical impact can be determined from this registry entry alone, as no results have been reported. Clinicians should await publication of Phase 1 safety, tolerability, and preliminary efficacy data before considering metarrestin for clinical use.
Phase 1 trial registration with no results reported; describes planned conduct and safety/dose-finding objectives in an early-stage oncology study.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be determined from this registry entry alone, as no results have been reported. Clinicians should await publication of Phase 1 safety, tolerability, and preliminary efficacy data before considering metarrestin for clinical use.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04222413). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 116 participants (ESTIMATED). Conditions: Advanced Solid Tumors, Metastatic Pancreatic Cancer, Pediatric Solid Tumor, Advanced Breast Cancer, Malignant Peripheral Nerve Sheath Tumor, Colorectal Neoplasms. Interventions: DRUG: Metarrestin. Primary outcome measures: To identify the maximum tolerated dose (MTD) of metarrestin in subjects with metastatic solid tumors , 28 days; To determine the Objective Response Rate (ORR) according to Evaluation Criteria (RECIST 1.1) in patients treated with metarrestin at the MTD , every 2 months. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.