drugset / Trial / NCT05355701

A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.

NCT05355701

Phase 1 Recruiting 267 enrolled Pfizer
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors. This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "BRAF" and available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine: * People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day. * People with colorectal cancer may also receive cetuximab or cetuximab and mFOLFOX6 (Chemotherapy regimen). Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV). Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Timeline

Start
2022-07-05
Primary completion
2028-04-23
Completion
2029-10-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Binimetinib Small molecule Oral
Subject CLATURAFENIB Small molecule Oral
Subject Cetuximab Monoclonal antibody Intravenous
Subject Leucovorin Small molecule Intravenous
Subject Midazolam Small molecule
Subject Oxaliplatin Small molecule Intravenous
Subject fluorouracil Small molecule Intravenous