Actively Recruiting

Phase 1
Age: 12Years - 120Years
All Genders
NCT04222413

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

Led by National Cancer Institute (NCI) · Updated on 2026-04-24

116

Participants Needed

2

Research Sites

426 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older with confirmed solid tumors
  • Adults with confirmed pancreatic, colorectal, or breast cancer
  • Children aged 12 to under 18 years with confirmed solid tumors other than rhabdomyosarcoma
  • Disease that has spread to at least one other organ or recurred after removal of the primary tumor
  • Measurable tumor lesions per RECIST 1.1 criteria
  • Tumor progression after at least one standard chemotherapy treatment or no standard therapy options available
  • Recovery from any prior treatment side effects to grade 1 or less
  • Karnofsky or Lansky performance status of 70% or higher
  • Adequate blood counts, liver, kidney, and coagulation function
  • Use of effective contraception during and up to 120 days after treatment for individuals with childbearing potential
  • Willingness to stop nursing if applicable
  • Weight of at least 35 kg
  • Ability to understand and sign informed consent
  • Lesions accessible for biopsy (for certain adult cohorts)
  • Ability to swallow oral capsules
Not Eligible

You will not qualify if you...

  • Recent anticancer treatments including surgery, radiation, or chemotherapy within specified timeframes before study start
  • Use of medications that strongly affect CYP3A4 enzyme and cannot be safely stopped
  • Recent cardiomyopathy or serious heart conditions
  • Abnormal heart function or rhythm that increases risk of arrhythmia
  • Positive for HIV, hepatitis B or C on antiviral drugs
  • History of other cancers within 3 years, except certain non-invasive types
  • Rapidly progressing disease preventing study participation
  • Brain metastases or central nervous system disorders increasing neurotoxicity risk
  • Active significant infections including tuberculosis
  • History of seizures or EEG findings indicating seizure risk
  • Other serious medical conditions impairing study participation
  • Prior gastric bypass or malabsorption conditions, feeding tube or parenteral nutrition use
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University of Kansas

Fairway, Kansas, United States, 66205

Actively Recruiting

2

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

M

Murielle Hogu

CONTACT

U

Udo Rudloff, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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