Phase 1 Study of PF-07799544 Alone or with PF-07799933 in Adults With BRAF V600 Mutation Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and effects of PF-07799544 alone or combined with PF-07799933 as a potential treatment for adults with advanced solid tumors that have a BRAF V600 mutation. This phase 1ab open-label study is focused on patients with metastatic or recurrent solid tumors, excluding colorectal cancer. The trial includes two parts phase 1a studying PF-07799544 alone and phase 1b studying the combination of both drugs. Phase 1a enrollment is closed, while phase 1b is actively seeking participants. In this study, all participants receive both PF-07799544 and PF-07799933 as oral tablets taken at home twice daily. Treatment continues until cancer progression, unacceptable side effects, or a maximum of two years, with the option to extend therapy beyond two years. The study aims to understand patient experiences with these medicines and to determine their safety and effects. Participants will undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, lab abnormalities, vital signs, and physical exams from baseline through the treatment period and up to 28 days after the last dose. The primary outcome evaluates overall response rate during the two-year treatment. Additional pharmacokinetic data and long-term safety are also collected. The total participation duration may extend up to two years or longer if treatment continues.

A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors