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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years and Over
Gender All
More Inclusion & Exclusion Criteria

This study is seeking participants who meet the following eligibility criteria:

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05355701
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, Israel, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma, Non-Small-Cell Lung Cancer, Thyroid Cancer, Glioma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Monotherapy dose escalation (Part 1)

Participants will receive PF-07799933

Experimental: Combination dose escalation (Part 2)

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

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

Participants will receive PF-07799933

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

Participants will receive PF-07799933

Interventions

Drug: - PF-07799933

Tablet

Drug: - binimetinib

Tablet

Biological: - cetuximab

Injection for intravenous use

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Highlands Oncology Group, Fayetteville 4110486, Arkansas 4099753

Status

Recruiting

Address

Highlands Oncology Group

Fayetteville 4110486, Arkansas 4099753, 72703

Highlands Oncology Group, Rogers 4128894, Arkansas 4099753

Status

Recruiting

Address

Highlands Oncology Group

Rogers 4128894, Arkansas 4099753, 72758

Highlands Oncology Group, Springdale 4132093, Arkansas 4099753

Status

Recruiting

Address

Highlands Oncology Group

Springdale 4132093, Arkansas 4099753, 72762

Aurora 5412347, Colorado 5417618

Status

Recruiting

Address

Clinical and Translational Research Center (CTRC)

Aurora 5412347, Colorado 5417618, 80045

UCHealth Sue Anschutz-Rodgers Eye Center, Aurora 5412347, Colorado 5417618

Status

Recruiting

Address

UCHealth Sue Anschutz-Rodgers Eye Center

Aurora 5412347, Colorado 5417618, 80045

Aurora 5412347, Colorado 5417618

Status

Recruiting

Address

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora 5412347, Colorado 5417618, 80045

Aurora 5412347, Colorado 5417618

Status

Recruiting

Address

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora 5412347, Colorado 5417618, 80045

Aurora 5412347, Colorado 5417618

Status

Recruiting

Address

University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

Aurora 5412347, Colorado 5417618, 80045

Miami 4164138, Florida 4155751

Status

Recruiting

Address

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami 4164138, Florida 4155751, 33136

Brigham and Women's Hospital, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Brigham and Women's Hospital

Boston 4930956, Massachusetts 6254926, 02115

Dana-Farber Cancer Institute, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston 4930956, Massachusetts 6254926, 02215

DFCI Chestnut Hill, Newton 4945283, Massachusetts 6254926

Status

Recruiting

Address

DFCI Chestnut Hill

Newton 4945283, Massachusetts 6254926, 02459

Brigitte Harris Cancer Pavilion, Detroit 4990729, Michigan 5001836

Status

Recruiting

Address

Brigitte Harris Cancer Pavilion

Detroit 4990729, Michigan 5001836, 48202

Henry Ford Hospital, Detroit 4990729, Michigan 5001836

Status

Recruiting

Address

Henry Ford Hospital

Detroit 4990729, Michigan 5001836, 48202

Henry Ford Medical Center - Columbus, Novi 5004062, Michigan 5001836

Status

Recruiting

Address

Henry Ford Medical Center - Columbus

Novi 5004062, Michigan 5001836, 48377

MSK Monmouth, Middletown 5101170, New Jersey 5101760

Status

Recruiting

Address

MSK Monmouth

Middletown 5101170, New Jersey 5101760, 07748

MSK David H. Koch Center for Cancer Care, New York 5128581, New York 5128638

Status

Recruiting

Address

MSK David H. Koch Center for Cancer Care

New York 5128581, New York 5128638, 10021

New York 5128581, New York 5128638

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center 53rd street

New York 5128581, New York 5128638, 10022

Memorial Sloan Kettering Cancer Center, New York 5128581, New York 5128638

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York 5128581, New York 5128638, 10065

Cleveland 5150529, Ohio 5165418

Status

Recruiting

Address

Cleveland Clinic Taussig Cancer Center Investigational Pharmacy

Cleveland 5150529, Ohio 5165418, 44106

Cleveland Clinic, Cleveland 5150529, Ohio 5165418

Status

Recruiting

Address

Cleveland Clinic

Cleveland 5150529, Ohio 5165418, 44195

Providence Cancer Institute Franz Clinic, Portland 5746545, Oregon 5744337

Status

Recruiting

Address

Providence Cancer Institute Franz Clinic

Portland 5746545, Oregon 5744337, 97213

Providence Portland Medical Center, Portland 5746545, Oregon 5744337

Status

Recruiting

Address

Providence Portland Medical Center

Portland 5746545, Oregon 5744337, 97213

Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Sarah Cannon Research Institute - Pharmacy

Nashville 4644585, Tennessee 4662168, 37203

SCRI Oncology Partners, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

SCRI Oncology Partners

Nashville 4644585, Tennessee 4662168, 37203

TriStar Bone Marrow Transplant, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

TriStar Bone Marrow Transplant

Nashville 4644585, Tennessee 4662168, 37203

Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

TriStar Centennial Medical Center - Cell Processing Lab

Nashville 4644585, Tennessee 4662168, 37203

TriStar Centennial Medical center, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

TriStar Centennial Medical center

Nashville 4644585, Tennessee 4662168, 37203

START San Antonio, San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

START San Antonio

San Antonio 4726206, Texas 4736286, 78229

International Sites

Cross Cancer Institute, Edmonton 5946768, Alberta 5883102, Canada

Status

Not yet recruiting

Address

Cross Cancer Institute

Edmonton 5946768, Alberta 5883102, T6G 1Z2

The Ottawa Hospital - General Campus, Ottawa 6094817, Ontario 6093943, Canada

Status

Recruiting

Address

The Ottawa Hospital - General Campus

Ottawa 6094817, Ontario 6093943, K1H 8L6

Princess Margaret Cancer Centre, Toronto 6167865, Ontario 6093943, Canada

Status

Recruiting

Address

Princess Margaret Cancer Centre

Toronto 6167865, Ontario 6093943, M5G 2M9

Jewish General Hospital, Montreal 6077243, Quebec 6115047, Canada

Status

Recruiting

Address

Jewish General Hospital

Montreal 6077243, Quebec 6115047, H3T 1E2

McGill University Health Centre, Montreal 6077243, Quebec 6115047, Canada

Status

Recruiting

Address

McGill University Health Centre

Montreal 6077243, Quebec 6115047, H4A 3J1

Sheba Medical Center, Ramat Gan, Central District 294904, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, Central District 294904, 5265601

Sourasky Medical Center, Tel Aviv, Central District 294904, Israel

Status

Not yet recruiting

Address

Sourasky Medical Center

Tel Aviv, Central District 294904, 6423906

Hadassah Medical Center, Jerusalem 281184, Jerusalem 293198, Israel

Status

Recruiting

Address

Hadassah Medical Center

Jerusalem 281184, Jerusalem 293198, 9112001

Rambam Health Care Campus, Haifa 294801, Ḥeifā, Israel

Status

Recruiting

Address

Rambam Health Care Campus

Haifa 294801, Ḥeifā, 3109601

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