A Phase I Study of PF-07284892 in People with Advanced Solid Tumors

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Full Title

A Phase 1, Open-Label, Multi-Center, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Anti-Tumor Activity of PF-07284892 (ARRY-558) as a Single Agent and in Combination Therapy in Participants with Advanced Solid Tumors

Purpose

The purpose of study is to find the highest dose of the investigational drug PF-07284892 that can be given alone and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib in patients with advanced solid tumors containing certain genetic mutations. All medications in this study are taken orally (by mouth) except for cetuximab, which is given intravenously (by vein).

PF-07284892 is designed to block a protein called SHP2. Researchers think that blocking SHP2 may slow or stop cancer growth and/or make the cancer more likely to respond to other anticancer treatments

Eligibility

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

  • Patients must have advanced non-small cell lung cancer with an ALK or ROS gene fusion/rearrangement/translocation; colorectal cancer with a BRAF V600E mutation; or any advanced solid tumor with RAS, NF1, or BRAF class 3 mutations.
  • Patients’ cancers must continue to grow despite prior treatment that was completed at least two weeks before receiving the study therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alexander Drilon at 646-608-3758.

Protocol

21-182

Phase

I

Investigator

Co-Investigators