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

June 9, 2026 updated by: Pfizer

A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS

The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).

Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have:

  • a solid tumor which is metastatic or recurrent (excluding colorectal cancer)
  • tumor with the mutation (abnormal gene) called "BRAF V600"
  • received required prior treatment for cancer per cohort assigned.

All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.

Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • Royal Melbourne Hospital
  • Brazil
      • São Caetano do Sul, Brazil, 09541-270
        • Recruiting
        • Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
      • São Paulo, Brazil, 04014-002
        • Recruiting
        • IBCC - Núcleo de Pesquisa e Ensino
    • Santa Catarina
      • Lages, Santa Catarina, Brazil, 88501001
        • Recruiting
        • ANIMI - Unidade de Tratamento Oncologico
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute
      • Edmonton, Alberta, Canada, T6G 2C8
        • Recruiting
        • Alberta Health Services and The Governors of The University of Alberta
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre
      • Québec, Quebec, Canada, G1J 1Z4
        • Recruiting
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
  • Israel
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
      • Ramat Gan, Central District, Israel, 5265601
        • Recruiting
        • Sheba Medical Center
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9112001
        • Not yet recruiting
        • Hadassah Medical Center
    • Southern District
      • Beersheba, Southern District, Israel, 8410101
        • Recruiting
        • Soroka Medical Center
    • TELL ABĪB
      • Tel Aviv, TELL ABĪB, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • The University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • The Kirklin Clinic of UAB Hospital
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • University of Alabama at Birmingham - Phase I Clinical Trials Unit
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Highlands Oncology Group, PA
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Highlands Oncology Group, PA
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group, PA
    • California
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • Keck Hospital of USC
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • Los Angeles General Medical Center
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate
      • Pasadena, California, United States, 91105
        • Not yet recruiting
        • Keck Medical Center of USC Pasadena
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Helen Diller Medical Center at Parnassus Heights
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Helen Diller Family Comprehensive Cancer Center
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Medical Center, Investigational Pharmacy
      • Santa Monica, California, United States, 90404
        • Recruiting
        • The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt McKinley Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Not yet recruiting
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Ophthalmic Consultants of Boston Inc (OCB)
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • Mass General Waltham
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Brigitte Harris Cancer Pavilion
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Not yet recruiting
        • HealthPartners Frauenshuh Cancer Center
      • Saint Louis Park, Minnesota, United States, 55426
        • Not yet recruiting
        • Methodist Hospital Inpatient Pharmacy
      • Saint Paul, Minnesota, United States, 55101
        • Not yet recruiting
        • HealthPartners Cancer Center at regions Hospital
      • Saint Paul, Minnesota, United States, 55101
        • Not yet recruiting
        • Regions Hospital Pharmacy
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • MSK Basking Ridge.
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • MSK Monmouth.
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • MSK Bergen.
    • New York
      • Brewster, New York, United States, 10509
        • Not yet recruiting
        • Optum Medical Care, PC
      • Commack, New York, United States, 11725
        • Recruiting
        • MSK Commack.
      • Harrison, New York, United States, 10604
        • Recruiting
        • MSK Westchester.
      • Mount Kisco, New York, United States, 10549
        • Not yet recruiting
        • Optum Medical Care, PC
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
      • New York, New York, United States, 10016
        • Recruiting
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center - Main Campus
      • New York, New York, United States, 10022
        • Recruiting
        • Memorial Sloan Kettering Cancer Center 53rd street.
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center (Tisch Hospital)
      • New York, New York, United States, 10016
        • Recruiting
        • Laura & Isaac Perlmutter Cancer Center - NYU ACC
      • New York, New York, United States, 10032
        • Recruiting
        • CUIMC Research Pharmacy
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center - Neurological Institute of New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Faculty Group Practice
      • Uniondale, New York, United States, 11553
        • Recruiting
        • MSK Nassau.
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Institute Franz Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Not yet recruiting
        • UPMC Hillman Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, United States, 53718
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Phase 1b Inclusion Criteria:

  • Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer)
  • Measurable disease by RECIST version 1.1
  • Evidence of a BRAF V600 mutation
  • Prior therapy per tumor cohort
  • Adequate organ function per protocol

Phase 1b Exclusion Criteria:

  • Other active malignancy within 3 years
  • Presence of leptomeningeal disease
  • History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease
  • Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
  • Active gastrointestinal disease as defined per protocol
  • History of interstitial lung disease as defined per protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1a Monotherapy Dose Escalation
Participants will receive PF-07799544
Drug: PF-07799544
Tablet
Other Names:
  • ARRY-134
Experimental: Phase 1b Combination Dose Escalation
Participants will receive PF-07799544 and PF-07799933
Drug: PF-07799933
Tablet
Other Names:
  • ARRY-440
Drug: PF-07799544
Tablet
Other Names:
  • ARRY-134
Experimental: Phase 1b Combination Dose Expansion
Participants will receive PF-07799544 and PF-07799933
Drug: PF-07799933
Tablet
Other Names:
  • ARRY-440
Drug: PF-07799544
Tablet
Other Names:
  • ARRY-134

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs)
Time Frame: Cycle 1 (21 days)
DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation)
Cycle 1 (21 days)
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs)
Time Frame: Baseline to 28 days after last dose of study medication
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Baseline to 28 days after last dose of study medication
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities
Time Frame: Baseline to 28 days after last dose of study treatment
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 28 days after last dose of study treatment
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalities
Time Frame: Baseline to 28 days after last dose of study treatment
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 28 days after last dose of study treatment
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities
Time Frame: Baseline to 28 days after last dose of study treatment
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Baseline to 28 days after last dose of study treatment
Phase 1b Dose Expansion: Overall response rate (ORR)
Time Frame: Baseline to 2 years
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
Baseline to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1a monotherapy and Phase 1b combination dose escalation: ORR
Time Frame: Baseline to 2 years
ORR as assessed using the RECIST version 1.1.
Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with treatment-emergent adverse events (AEs)
Time Frame: Baseline to 2 years
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in vital sign abnormalities
Time Frame: Baseline to 2 years
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in laboratory abnormalities
Time Frame: Baseline to 2 years
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 2 years
Phase 1b Dose Expansion: Duration of Response (Overall and in CNS)
Time Frame: Baseline to 2 years
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
Baseline to 2 years
Phase 1b Dose Expansion: Intracranial response
Time Frame: Baseline to 2 years
Intracranial response by RECIST version 1.1 (for brain metastases)
Baseline to 2 years
Phase 1b Dose Expansion: Progression Free Survival (PFS)
Time Frame: Baseline to 2 years
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
Baseline to 2 years
PK Parameters: Maximum Observed Concentration (Cmax)
Time Frame: Baseline to 2 years
Single dose and multiple dose PK will be calculated as data permits
Baseline to 2 years
PK Parameters: Maximum Plasma Concentration (Tmax)
Time Frame: Baseline to 2 years
Single dose and multiple dose PK will be calculated as data permits
Baseline to 2 years
PK Parameters: Area Under Curve (AUC)
Time Frame: Baseline to 2 years
Single dose and multiple dose PK will be calculated as data permits
Baseline to 2 years
PK Parameters: terminal elimination half-life (t½)
Time Frame: Baseline to 2 years
Singe dose and multiple dose PK will be calculated as data permits
Baseline to 2 years
PK Parameters: Apparent Oral Clearance (CL/F)
Time Frame: Baseline to 2 years
Singe dose and multiple dose PK will be calculated as data permits
Baseline to 2 years
PK Parameters: Apparent Volume of Distribution (Vz/F)
Time Frame: Baseline to 2 years
Singe dose and multiple dose PK will be calculated as data permits
Baseline to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Estimated)

August 2, 2027

Study Completion (Estimated)

June 18, 2029

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4901001
  • NCT05538130 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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