RecruitingPhase 1NCT04222413

Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors

First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors


Sponsor

National Cancer Institute (NCI)

Enrollment

116 participants

Start Date

Oct 27, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called Metarrestin (ML-246) in patients with solid tumors or specific cancers (pancreatic, colorectal, or breast) that have spread and no longer respond to standard treatments. It is an early-phase safety and dosing study. **You may be eligible if...** - You are 12 or older - You have a confirmed solid cancer that has spread to at least one other organ and is not curable with surgery - Your cancer has progressed after at least one standard chemotherapy treatment - You are in reasonably good physical health - Your blood counts, clotting factors, and organ function meet study requirements **You may NOT be eligible if...** - You have rhabdomyosarcoma (a specific type of muscle cancer) - Your cancer has not been treated with any prior chemotherapy - You have significant ongoing toxicity from prior treatment - Your organ function (blood counts, liver, kidneys) does not meet minimum requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetarrestin

Phase IA: Loading dose on Day 1 of Cycle 1 for Dose Levels 1-7. Loading dose on Days 1 and 3 of Cycle 1 for Dose Levels 8-11. After the loading dose on Day 1 or Days 1 and 3 of Cycle 1, continue on Mondays-Wednesdays-Fridays of every following cycle. Phase IB: PO according to the dose and schedule estimated during Phase IA


Locations(2)

University of Kansas

Fairway, Kansas, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT04222413


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