Title
A Phase 1A/B Open-Label Master Study of PF-07799544 as a Single-Agent and in Combination With Other Targeted Agents in Participants With BRAF-Mutant Melanoma and Other Solid Tumors

Description
A Phase 1A/B Open-Label Master Study of PF-07799544 as a Single-Agent and in Combination With Other Targeted Agents in Participants With BRAF-Mutant Melanoma and Other Solid Tumors

Objective
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).

Treatment 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.

Key Eligibility Phase 1b 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

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

Applicable Disease Sites
Melanoma/Skin cancer

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital