NCT04222413

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

Recruiting now Phase 1 Last updated 8 April 2026

What this trial tests

Phase 1 trial testing Metarrestin in Advanced Solid Tumors in 116 participants. Currently enrolling.

Timeline

27 October 2020

Primary endpoint
31 December 2027

31 December 2028

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	116
Start date	27 October 2020
Primary completion	31 December 2027
Estimated completion	31 December 2028
Sites	2 locations across United States

Drugs / interventions tested

• Metarrestin — full drug profile →

Conditions studied

• Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
• Metastatic Pancreatic Cancer — all drugs for Metastatic Pancreatic Cancer →
• Pediatric Solid Tumor — all drugs for Pediatric Solid Tumor →
• Advanced Breast Cancer — all drugs for Advanced Breast Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 12 to 120, any sex, with Advanced Solid Tumors or Metastatic Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging strategies for treating metastasis.
   Esposito M, Ganesan S, Kang Y. · · 2021 · cited 119× · PMID 33899000 · DOI 10.1038/s43018-021-00181-0
2. Targeting Ribosome Biogenesis in Cancer: Lessons Learned and Way Forward.
   Zisi A, Bartek J, Lindström MS. · · 2022 · cited 67× · PMID 35565259 · DOI 10.3390/cancers14092126
3. The impact of ribosome biogenesis in cancer: from proliferation to metastasis.
   Hwang SP, Denicourt C. · · 2024 · cited 43× · PMID 38633862 · DOI 10.1093/narcan/zcae017
4. New Model Systems and the Development of Targeted Therapies for the Treatment of Neurofibromatosis Type 1-Associated Malignant Peripheral Nerve Sheath Tumors.
   Williams KB, Largaespada DA. · · 2020 · cited 29× · PMID 32353955 · DOI 10.3390/genes11050477
5. Diagnosis and Treatment of Peripheral and Cranial Nerve Tumors with Expert Recommendations: An EUropean Network for RAre CANcers (EURACAN) Initiative.
   Pellerino A, Verdijk RM, Nichelli L, Andratschke NH, et al · · 2023 · cited 20× · PMID 37046591 · DOI 10.3390/cancers15071930
6. Discovery and Optimization of Pyrrolopyrimidine Derivatives as Selective Disruptors of the Perinucleolar Compartment, a Marker of Tumor Progression toward Metastasis.
   Frankowski KJ, Patnaik S, Wang C, Southall N, et al · · 2022 · cited 14× · PMID 35696646 · DOI 10.1021/acs.jmedchem.2c00204
7. Crossing boundaries of light microscopy resolution discerns novel assemblies in the nucleolus.
   Correll CC, Rudloff U, Schmit JD, Ball DA, et al · · 2024 · cited 13× · PMID 38758429 · DOI 10.1007/s00418-024-02297-7
8. Small Molecule with Big Impact: Metarrestin Targets the Perinucleolar Compartment in Cancer Metastasis.
   Kashyap VK, Sharma BP, Pandey D, Singh AK, et al · · 2024 · cited 2× · PMID 39768145 · DOI 10.3390/cells13242053