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

RECRUITING

NCT05355701

PHASE1

Sponsor: Pfizer

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.

Official title: A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

267

Start Date

2022-07-05

Completion Date

2030-05-06

Last Updated

2026-03-27

Healthy Volunteers

No

Conditions

Melanoma Non-Small-Cell Lung Cancer Thyroid Cancer Glioma Advanced Colorectal Cancer (Part 1)

Interventions

DRUG

PF-07799933

Tablet

DRUG

binimetinib

Tablet

BIOLOGICAL

cetuximab

Injection for intravenous use

DRUG

midazolam

syrup

DRUG

fluorouracil

Injection for intravenous use

DRUG

leucovorin

Injection for intravenous use

DRUG

oxaliplatin

Injection for intravenous use

Locations (41)

Highlands Oncology Group

Fayetteville, Arkansas, United States

Highlands Oncology Group

Rogers, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Clinical and Translational Research Center (CTRC)