A Phase IA/IB Study of Different Doses of BI 907828 Combined with BI 754091 and BI 754111 in People with Advanced Solid Tumors

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A Phase Ia/Ib, Open Label, Dose-escalation Study of the Combination of BI 907828 with BI 754091 and BI 754111, Followed by Expansion Cohorts, in Patients with Advanced Solid Tumors

Purpose

In the phase IA part of this study, researchers want to find the best dose of the investigational drug BI 907828 that can be given in combination with BI 754091 and BI 754111 in patients with advanced solid tumors. In the phase IB part, they will assess the safety and effectiveness of this dose in combination with the other two drugs in patients with advanced non-small cell lung cancer, melanoma, soft-tissue sarcoma, and liver cancer.

BI 907828 is designed to block the protein MDM2, which can cause some cancer cells to stop functioning and die. BI 754091 and BI754111 are antibodies (proteins) designed to bind to and block receptors found on the surface of cancer cells that play a role in cancer growth.

Researchers think that giving these three drugs together may be more effective than giving them alone. BI 907828 is taken orally (by mouth) and BI 754091 and BI 754111 are given intravenously (by vein).

Eligibility

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

  • Patients in the phase IA portion of the study must have inoperable or metastatic cancer that cannot be cured using standard therapies.
  • Patients in the phase IB portion must have advanced non-small cell lung cancer, melanoma, liposarcoma or other soft-tissue sarcoma, or liver cancer that continues to grow despite standard treatments and does not contain TP53 mutations.
  • Patients should recover from the serious side effects of previous therapies.
  • 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. David Hyman at 646-888-4544.

Protocol

19-325

Phase

I

Investigator

Co-Investigators