A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS ASINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTSIN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Contact:

NCT Number:

Protocol:

AAAU5536

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

The purpose of this study is to learn about the safety (the impact of the study drug on your body) and the effects of study drug PF-07799544 for specific types of cancer on the body and to find the best dose for treating certain cancers. For BRAF (B-raf proto-oncogene serine/threonine kinase) mutated solid tumors, PF-07799544 may be combined with encorafenib, also known as BRAFTOVI® (an FDA approved cancer medication). The study drug PF-07799544 is an investigational drug because it is not FDA approved for use in this country. The study drug encorafenib is approved in this country and is available by prescription for approved indications, however is is considered investigational in this study because it is not being used according to its FDA approved label. Different doses of the study drug, PF-07799544, will be given to several study participants. The first several study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until side effects occur that require the dose to be lowered.

Are you Eligible? (Inclusion Criteria)

  • Must be 18 years old or older. - Must be willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. - Your brain metastasis/primary brain tumor does not require immediate local intervention (surgery, radiosurgery) in the opinion of the investigator. - Must not have active inflammatory gastrointestinal disease, history of inflammatory bowel disease, chronic diarrhea, previous gastric resection or lap band surgery or inability to swallow and retain study treatment.

Specialty Area(s)

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032