RecruitingPhase 1NCT05355701

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

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

Sponsor

Pfizer

Enrollment

267 participants

Start Date

Jul 5, 2022

Study Type

INTERVENTIONAL

Conditions

Melanoma

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.

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new targeted drug called PF-07799933, which is designed to block an abnormal protein (BRAF) that drives the growth of certain cancers. It is open to people with advanced solid tumors — including brain tumors — that have a BRAF gene mutation. **You may be eligible if...** - You have advanced or metastatic solid cancer, including primary brain tumors, with a confirmed BRAF gene mutation (V600 or certain non-V600 types) - Your cancer has progressed during or after your last treatment and there are no satisfactory alternatives - Certain cancer types (like melanoma or colorectal cancer) may require specific prior therapies based on the study cohort **You may NOT be eligible if...** - You have a brain metastasis larger than 4 cm - You are currently on other systemic anti-cancer therapy - You have a history of retinal vein occlusion or retinal degenerative disease - You have a neuromuscular disorder that causes elevated muscle enzyme levels (creatine kinase) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPF-07799933

Tablet

DRUGbinimetinib

Tablet

BIOLOGICALcetuximab

Injection for intravenous use

DRUGmidazolam

syrup

DRUGfluorouracil

Injection for intravenous use

DRUGleucovorin

Injection for intravenous use

DRUGoxaliplatin

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)