A Phase IB/II Study of RMC-4630 plus Cobimetinib in Adults with Genetically Altered Recurrent or Persistent Solid Tumors

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Full Title

A Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 with Cobimetinib in Adult Participants with Relapsed/Refractory Solid Tumors and a Phase 1b Study of RMC-4630 with Osimertinib in Participants with Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Purpose

The purpose of this study is to find the highest dose of the investigational drug RMC-4630 that can be given in combination with cobimetinib in patients with solid tumors that have come back or continued to grow despite prior therapy and contain certain genetic changes. RMC-4630 inhibits a protein called SHP-2. Cobimetinib inhibits the MEK protein. These drugs interrupt different steps in the communication pathway that tells cancer cells to grow and divide.

Patients in this study have tumors containing a genetic change that can promote the growth of cancer by activating these same steps in the communication pathway. Some cancers may not respond well to either drug when given alone. Researchers think that combining cobimetinib with RMC-4630 will work better. Both medications are 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 metastatic cancer that contains a certain mutation in the KRAS, NF1, or BRAF genes. Examples of these tumors include non-small cell lung cancer and colorectal cancer.
  • At least 4 weeks must pass between the completion of prior therapies and receipt of the study treatment.
  • 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. Kathryn Arbour at 646-497-9163.

Protocol

20-321

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators