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

NCT ID: NCT05355701

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2028-09-28

Brief Summary

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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 (called binimetinib) 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. 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.

Detailed Description

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Conditions

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Melanoma Non-Small-Cell Lung Cancer Thyroid Cancer Glioma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy dose escalation (Part 1)

Participants will receive PF-07799933

Group Type EXPERIMENTAL

PF-07799933

Intervention Type DRUG

Tablet

Combination dose escalation (Part 2)

Participants will receive PF-07799933 in combination with binimetinib or cetuximab

Group Type EXPERIMENTAL

PF-07799933

Intervention Type DRUG

Tablet

binimetinib

Intervention Type DRUG

Tablet

cetuximab

Intervention Type BIOLOGICAL

Injection for intravenous use

Dose expansion (Part 3) - Tumor and mutation specific Cohort 1

Participants will receive PF-07799933

Group Type EXPERIMENTAL

PF-07799933

Intervention Type DRUG

Tablet

Dose expansion (Part 3) - Tumor and mutation specific Cohort 2

Participants will receive PF-07799933

Group Type EXPERIMENTAL

PF-07799933

Intervention Type DRUG

Tablet

binimetinib

Intervention Type DRUG

Tablet

Interventions

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PF-07799933

Tablet

Intervention Type DRUG

binimetinib

Tablet

Intervention Type DRUG

cetuximab

Injection for intravenous use

Intervention Type BIOLOGICAL

Other Intervention Names

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ARRY-440 Mektovi, PF-06811462, MEK162 Erbitux

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of advanced/metastatic solid tumor including primary brain tumor.
* Qualifying BRAF alteration (V600 or non-V600 Class II/Class III BRAF alteration), in tumor tissue and/or blood (ie circulating tumor deoxyribonucleic acid \[DNA\], or ctDNA).
* Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1 and Part 2).
* Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies

Exclusion Criteria

* Brain metastasis larger than 4 cm
* Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
* For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Highlands Oncology Group

Fayetteville, Arkansas, United States

Site Status RECRUITING

Highlands Oncology Group

Rogers, Arkansas, United States

Site Status RECRUITING

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status RECRUITING

Clinical and Translational Research Center (CTRC)

Aurora, Colorado, United States

Site Status RECRUITING

UCHealth Sue Anschutz-Rodgers Eye Center

Aurora, Colorado, United States

Site Status RECRUITING

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States

Site Status RECRUITING

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, United States

Site Status RECRUITING

University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

Aurora, Colorado, United States

Site Status RECRUITING

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, United States

Site Status RECRUITING

University of Miami Sylvester Comprehensive Cancer Center-The Griffin Research Building

Miami, Florida, United States

Site Status RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

DFCI Chestnut Hill

Newton, Massachusetts, United States

Site Status RECRUITING

Brigitte Harris Cancer Pavilion

Detroit, Michigan, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Henry Ford Medical Center - Columbus

Novi, Michigan, United States

Site Status RECRUITING

CT Scan and Echo Only: Henry Ford Medical Center-Plymouth

Plymouth, Michigan, United States

Site Status RECRUITING

MSK Monmouth

Middletown, New Jersey, United States

Site Status RECRUITING

MSK David H. Koch Center for Cancer Care

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center 53rd street

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Cleveland Clinic Taussig Cancer Center Investigational Pharmacy

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

Site Status RECRUITING

Providence Portland Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Sarah Cannon Research Institute - Pharmacy

Nashville, Tennessee, United States

Site Status RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

Tennesse Oncology, PLLC

Nashville, Tennessee, United States

Site Status RECRUITING

TriStar Bone Marrow Transplant

Nashville, Tennessee, United States

Site Status RECRUITING

TriStar Centennial Medical Center - Cell Processing Lab

Nashville, Tennessee, United States

Site Status RECRUITING

TriStar Centennial Medical center

Nashville, Tennessee, United States

Site Status RECRUITING

START San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status NOT_YET_RECRUITING

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Site Status RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Sheba Medical Center

Ramat Gan, Central District, Israel

Site Status RECRUITING

Sourasky Medical Center

Tel Aviv, Central District, Israel

Site Status NOT_YET_RECRUITING

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Site Status RECRUITING

Rambam Health Care Campus

Haifa, Ḥeifā, Israel

Site Status RECRUITING

Countries

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United States Canada Israel

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

Phone: 1-800-718-1021

Email: [email protected]

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4761001

To obtain contact information for a study center near you, click here.

Other Identifiers

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BRAF Class 2

Identifier Type: OTHER

Identifier Source: secondary_id

C4761001

Identifier Type: -

Identifier Source: org_study_id