A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors

NCT ID: NCT05538130

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

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2028-10-11

Brief Summary

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The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) administered as a single agent and in combination with other study medications in people with solid tumors. This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799544. PF-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this could change to once daily or another frequency). Depending on the part of the study, participants may also receive another study medicine.

* In the first part of the study, people with melanoma or other solid tumors may also receive encorafenib. Encorafenib comes as a capsule and is taken once per day.
* In the second part of the study, people with melanoma or other cancers with abnormalities in a gene called "BRAF" will receive PF-07799544 with other study medicines (for example, PF-07799933).

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 Glioma Thyroid Cancer Non-Small Cell Lung Cancer Malignant Neoplasms Brain Neoplasms Colorectal Cancer

Keywords

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Proto-Oncogene Proteins B-raf Brain neoplasms Melanoma Carcinoma, Non-Small-Cell Lung Neoplasm by Histologic Type CRC MAPK

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 (Phase 1a)

Participants will receive PF-07799544

Group Type EXPERIMENTAL

PF-07799544

Intervention Type DRUG

Tablet

encorafenib

Intervention Type DRUG

Capsule

Phase 1b Substudy B Combination Dose Escalation

Participants will receive PF-07799544 and PF-07799933

Group Type EXPERIMENTAL

PF-07799544

Intervention Type DRUG

Tablet

PF-07799933

Intervention Type DRUG

Tablet

Phase 1b Substudy B Combination Dose Expansion

Participants will receive PF-07799544 and PF-07799933

Group Type EXPERIMENTAL

PF-07799544

Intervention Type DRUG

Tablet

PF-07799933

Intervention Type DRUG

Tablet

Phase 1b Substudy C Combination Dose Expansion

Participants will receive PF-07799544 and PF-07799933

Group Type EXPERIMENTAL

PF-07799544

Intervention Type DRUG

Tablet

PF-07799933

Intervention Type DRUG

Tablet

Interventions

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PF-07799544

Tablet

Intervention Type DRUG

PF-07799933

Tablet

Intervention Type DRUG

encorafenib

Capsule

Intervention Type DRUG

Other Intervention Names

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ARRY-134 ARRY-440 BRAFTOVI

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation
* Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation
* For Substudy B, histological or cytological diagnosis of advanced/metastatic melanoma
* For Substudy C, unresectable or adv/metastatic solid tumor progressed on, or with demonstrated intolerance to SOC, excluding melanoma,
* For Substudy B and C, measurable disease by RECIST version 1.1
* For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II/III alteration in tumor tissue and/or blood
* For Substudy C, evidence of a BRAF founder alteration (non-V600 Class II/III BRAF alteration)

Exclusion Criteria

* Brain metastasis larger than 4 cm
* 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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The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, United States

Site Status NOT_YET_RECRUITING

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status NOT_YET_RECRUITING

University of Alabama at Birmingham - Phase I Clinical Trials Unit

Birmingham, Alabama, United States

Site Status NOT_YET_RECRUITING

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status NOT_YET_RECRUITING

Highlands Oncology Group

Fayetteville, Arkansas, United States

Site Status RECRUITING

Highlands Oncology Group

Rogers, Arkansas, United States

Site Status RECRUITING

Highlands Oncology Group, PA

Springdale, Arkansas, United States

Site Status RECRUITING

The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status NOT_YET_RECRUITING

UCSF Medical Center, Investigational Pharmacy

San Francisco, California, United States

Site Status NOT_YET_RECRUITING

The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)

Santa Monica, California, United States

Site Status NOT_YET_RECRUITING

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Moffitt McKinley Hospital

Tampa, 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

Dana-Farber Cancer Institute

Boston, 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

HealthPartners Frauenshuh Cancer Center

Saint Louis Park, Minnesota, United States

Site Status NOT_YET_RECRUITING

Methodist Hospital Inpatient Pharmacy

Saint Louis Park, Minnesota, United States

Site Status NOT_YET_RECRUITING

HealthPartners Cancer Center at regions Hospital

Saint Paul, Minnesota, United States

Site Status NOT_YET_RECRUITING

Regions Hospital Pharmacy

Saint Paul, Minnesota, United States

Site Status NOT_YET_RECRUITING

MSK Basking Ridge.

Basking Ridge, New Jersey, United States

Site Status RECRUITING

MSK Monmouth.

Middletown, New Jersey, United States

Site Status RECRUITING

MSK Bergen.

Montvale, New Jersey, United States

Site Status RECRUITING

Optum Medical Care, PC

Brewster, New York, United States

Site Status NOT_YET_RECRUITING

MSK Commack.

Commack, New York, United States

Site Status RECRUITING

MSK Westchester.

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center 53rd street.

New York, New York, United States

Site Status RECRUITING

Columbia University Irving Medical Center

New York, New York, United States

Site Status RECRUITING

Columbia University Medical Center - Neurological Institute of New York

New York, New York, United States

Site Status RECRUITING

CUIMC Research Pharmacy

New York, New York, United States

Site Status RECRUITING

The Trustees of Columbia University

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, United States

Site Status RECRUITING

Brooklyn Radiation Oncology, PC

Richmond Hill, New York, United States

Site Status NOT_YET_RECRUITING

MSK Nassau.

Uniondale, New York, United States

Site Status RECRUITING

Clinical Research Alliance

Westbury, New York, United States

Site Status NOT_YET_RECRUITING

Cleveland Clinic Taussig Cancer Center Investigational Pharmacy

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Taussig Cancer Center

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

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Sarah Cannon Research Institute- Pharmacy

Nashville, Tennessee, United States

Site Status RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status RECRUITING

University of Washington Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status RECRUITING

Centro de Oncologia - CEON+ - Unidade São Caetano do Sul

São Caetano do Sul, São Paulo, Brazil

Site Status NOT_YET_RECRUITING

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status RECRUITING

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Site Status RECRUITING

Sunnybrook Research Institute

Toronto, 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

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Site Status RECRUITING

Rabin Medical Center

Petah Tikva, Central District, Israel

Site Status RECRUITING

Sheba Medical Center

Ramat Gan, Central District, Israel

Site Status RECRUITING

Hadassah Medical Center

Jerusalem, Jerusalem, Israel

Site Status NOT_YET_RECRUITING

Soroka Medical Center

Beersheba, Southern District, Israel

Site Status RECRUITING

Sourasky Medical Center

Tel Aviv, TELL ABĪB, Israel

Site Status RECRUITING

Countries

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United States Australia Brazil 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=C4901001

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

Other Identifiers

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C4901001

Identifier Type: -

Identifier Source: org_study_id