Mantra-2: Milademetan in advanced/metastatic solid tumors incl. sarcomas


Agents: Milademetan
Phase II
Status Recruiting
Sponsor Rain Oncology


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This is a phase II basket study that evaluates the safety and efficacy of milademetan in patients with advanced or metastatic solid tumors with specific mutations (wild-type (WT) TP53 or MDM2) after standard-of-care therapy.


WHO is the trial for?

  • Patients with advanced/metastatic tumors incl. sarcomas
  • Tumors must exhibit specific mutations: Either wild-type p53 or a MDM2 gene amplification
  • Patients must have received prior standard-of-care therapy
  • Overall health of the patient must be good (ECOG performance status of 0 or 1)

WHAT is the key question that this trial is attempting to answer?

This study aims to investigate a drug called Milademetan. The trial tries to assess the safetey and efficacy of milademetan in advanced/solid tumors that show certain kinds of genetic mutations such as wild-type p53 and MDM2 gene amplification.

WHY patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease. The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

This study is open for recruitment.

WHERE is the trial available?

The trial is currently open in the US, but is planned to be rolled out in other countries as well.

For further information please check here.

STUDY DESIGN: What does the study look like?

This study has only one arm. That means that all participating patients will receive milademetan. It is given orally and in a 28-day cylce. Patients will take the drug on days 1-3 and 15-17 in a dosage of 260mg/day.

Treatment will continue unless a patient’s disease worsens, there are unacceptable adverse events (side effects), or a patient decides to leave the trial.

HOW do I get more information?

Patient organizations supporting sarcoma and/or GIST patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations serving GIST and/or sarcoma patients. If there are no such organization in your country, please email us for more information:


Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.