A Phase 1 Study of PF-07799933 Alone or with Binimetinib or Cetuximab in People with Solid Tumors

Full Title

A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti Tumor Activity of PF-07799933 (ARRY-440) as a Single Agent and in Combination Therapy in Participants 16 Years and Older With Advanced Solid Tumors with BRAF Alterations

Purpose

The purpose of this study is to find the highest dose of the investigational drug PF-07799933 that can be given alone and in combination with binimetinib or cetuximab in people with advanced solid tumors that have continued to grow despite treatment and contain a mutation in the BRAF gene. A mutated BRAF gene makes a protein that sends signals to cancer cells to grow and divide. While some anti-cancer drugs only work for certain BRAF mutations, the investigational drug PF-07799933 may target all types of BRAF mutant proteins, blocking them from sending these signals and causing cancer cells to die.

PF-07799933 may work better when given in combination with the drugs binimetinib or cetuximab, depending on the cancer type and the type of BRAF gene mutation found in a person’s cancer cells. Binimetinib and cetuximab are targeted drugs that also block growth signals, so combining PF-07799933 with these drugs may more effectively stop the growth signals in cancer cells.

Participants in this study will receive PF-07799933 alone, PF-07799933 with binimetinib, or PF-07799933 with cetuximab. PF-07799933 and binimetinib are taken orally (by mouth) and cetuximab is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

• Participants must have an inoperable or metastatic solid tumor that has continued to grow despite prior treatment.
• Patients’ tumors must contain mutated BRAF.
• Patients must be able to walk and do routine activities for more than half of their normal waking hours.
• This study is for people age 16 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Rona Yaeger at 646-888-5109.