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A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
Trial Status: active
The purpose of this clinical trial is to learn the safety and effects of the study
medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults
with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a
single agent (Phase 1a) and PF-07799544 in combination with another study medicine called
PF-07799933 (Phase 1b).
Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are
seeking participants who have:
- a solid tumor which is metastatic or recurrent (excluding colorectal cancer)
- tumor with the mutation (abnormal gene) called "BRAF V600"
- received required prior treatment for cancer per cohort assigned.
All participants in this study will receive both study medicines. Both study medicines
are tablets that are taken by mouth at home twice a day.
Participants will receive study medicines until their cancer is no longer responding,
unacceptable side effects, or 2 years. Participants may continue to receive study therapy
beyond 2 years. We will examine the experiences of people receiving the study medicines.
This will help us determine if the study medicines are safe and effective.
Inclusion Criteria
Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer)
Measurable disease by RECIST version 1.1
Evidence of a BRAF V600 mutation
Prior therapy per tumor cohort
Adequate organ function per protocol Phase 1b
Exclusion Criteria
Other active malignancy within 3 years
Presence of leptomeningeal disease
History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease
Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
Active gastrointestinal disease as defined per protocol
History of interstitial lung disease as defined per protocol
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05538130.
