A Phase IA Study of M3814 Combined with Radiotherapy in Patients with Advanced Solid Tumors

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Full Title

An Open-Label, Phase Ia/Ib Trial of the DNA-PK Inhibitor MSC2490484A in Combination with Radiotherapy in Patients with Advanced Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug M3814 that can be given safely in combination with radiation therapy in patients with advanced solid tumors or cancer metastases in the head, neck, or chest that cannot be treated with surgery or with other anticancer treatments alone. Researchers think that M3814 plus radiation therapy may be more effective than radiotherapy alone or radiotherapy plus chemotherapy.

Most cancer treatments work by damaging the DNA (genetic information) in cancer cells. This damage can hinder the cell’s ability to repair itself, which causes damaged cancer cells to die. An enzyme called DNA-PK, part of the mechanism that helps repair DNA damage, can prevent or delay the beneficial effects of anticancer therapies.

DNA damage caused by a cancer treatment such as radiotherapy can trigger the production of high levels of DNA-PK. M3814 is designed to block DNA-PK and prevent damaged cancer cells from repairing themselves, enhancing the effectiveness of treatment. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have an advanced solid tumor in the head/neck or chest (including lymphoma) and be candidates for radiation therapy.
  • At least 4 weeks must have passed between the completion of prior chemotherapy, immunotherapy, hormonal therapy, or biologic therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Nancy Lee at 212-639-3341.

Protocol

20-057

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators