Actively Recruiting

Phase 1
Age: 16Years +
All Genders
ID05538130

A Phase 1a/b Open-Label Study of PF-07799544 Alone and with PF-07799933 in Adults with BRAF-Mutant Melanoma and Other Advanced Solid Tumors

Led by Pfizer · Updated on 2026-06-05

124

Participants Needed

83

Research Sites

98 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effects of the study medicine PF-07799544, alone or combined with another medicine called PF-07799933, as a potential treatment for adults with advanced solid tumors that have a BRAF V600 mutation. This clinical trial includes two parts: Phase 1a testing PF-07799544 alone and Phase 1b testing PF-07799544 together with PF-07799933. Phase 1a is closed for enrollment, and Phase 1b focuses on participants with metastatic or recurrent solid tumors, excluding colorectal cancer, who have received prior cancer treatments. In this study, all participants receive both PF-07799544 and PF-07799933 as oral tablets taken twice daily at home. Treatment continues until the cancer stops responding, unacceptable side effects occur, or up to two years, with the option to continue beyond two years. The trial is designed to observe the experiences of participants using these medicines to assess safety and treatment effects. Participants will be monitored through regular assessments including evaluations of side effects, laboratory tests, vital signs, and physical exams from the start of treatment until 28 days after stopping the study drugs. The main measure is to track dose-limiting toxicities within the first 21 days of treatment cycles and overall response rate up to two years. Additional monitoring includes treatment-emergent adverse events, changes in lab results and vital signs, and pharmacokinetics to understand how the drugs behave in the body.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of advanced or metastatic solid tumor excluding colorectal cancer
  • Measurable disease by RECIST version 1.1
  • Evidence of a BRAF V600 mutation in the tumor
  • Prior therapy received as required per tumor cohort
  • Adequate organ function according to study protocol
Not Eligible

You will not qualify if you...

  • Active malignancy other than the study tumor within the past 3 years
  • Presence of leptomeningeal disease
  • History or current evidence of retinal vein occlusion or retinal degenerative disease
  • Neuromuscular disorder with elevated creatine kinase
  • Active gastrointestinal disease as defined by study protocol
  • History of interstitial lung disease as defined by study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Repeated 21-day cycles until disease progression or discontinuation

Participants receive study medicine PF-07799544 alone or in combination with PF-07799933 as part of dose escalation and expansion.

Visits every cycle for treatment and safety assessments

Follow-up

Duration - Up to 2 years

Participants are monitored for efficacy and safety outcomes after treatment ends, including response and adverse events up to 2 years.

Periodic visits during follow-up for assessments

Trial Site Locations

Total: 83 locations

1

The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

The University of Alabama at Birmingham

Birmingham, Alabama, United States, 35249

Actively Recruiting

3

University of Alabama at Birmingham - Phase I Clinical Trials Unit

Birmingham, Alabama, United States, 35249

Actively Recruiting

4

Highlands Oncology Group, PA

Fayetteville, Arkansas, United States, 72703

Actively Recruiting

5

Highlands Oncology Group, PA

Rogers, Arkansas, United States, 72758

Actively Recruiting

6

Highlands Oncology Group, PA

Springdale, Arkansas, United States, 72762

Actively Recruiting

7

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

Los Angeles, California, United States, 90025

Actively Recruiting

8

Keck Hospital of USC

Los Angeles, California, United States, 90033

Not Yet Recruiting

9

Los Angeles General Medical Center

Los Angeles, California, United States, 90033

Not Yet Recruiting

10

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Not Yet Recruiting

11

Keck Medical Center of USC Pasadena

Pasadena, California, United States, 91105

Not Yet Recruiting

12

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States, 94143

Actively Recruiting

13

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, United States, 94143

Actively Recruiting

14

UCSF Medical Center, Investigational Pharmacy

San Francisco, California, United States, 94158

Actively Recruiting

15

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

Santa Monica, California, United States, 90404

Actively Recruiting

16

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

Tampa, Florida, United States, 33612

Actively Recruiting

17

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

18

Moffitt McKinley Hospital

Tampa, Florida, United States, 33612

Actively Recruiting

19

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

Not Yet Recruiting

20

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

21

Ophthalmic Consultants of Boston Inc (OCB)

Boston, Massachusetts, United States, 02114

Actively Recruiting

22

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

23

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

24

Mass General Waltham

Waltham, Massachusetts, United States, 02451

Actively Recruiting

25

Brigitte Harris Cancer Pavilion

Detroit, Michigan, United States, 48202

Actively Recruiting

26

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

27

HealthPartners Frauenshuh Cancer Center

Saint Louis Park, Minnesota, United States, 55426

Not Yet Recruiting

28

Methodist Hospital Inpatient Pharmacy

Saint Louis Park, Minnesota, United States, 55426

Not Yet Recruiting

29

HealthPartners Cancer Center at regions Hospital

Saint Paul, Minnesota, United States, 55101

Not Yet Recruiting

30

Regions Hospital Pharmacy

Saint Paul, Minnesota, United States, 55101

Not Yet Recruiting

31

MSK Basking Ridge.

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

32

MSK Monmouth.

Middletown, New Jersey, United States, 07748

Actively Recruiting

33

MSK Bergen.

Montvale, New Jersey, United States, 07645

Actively Recruiting

34

Optum Medical Care, PC

Brewster, New York, United States, 10509

Not Yet Recruiting

35

MSK Commack.

Commack, New York, United States, 11725

Actively Recruiting

36

MSK Westchester.

Harrison, New York, United States, 10604

Actively Recruiting

37

Optum Medical Care, PC

Mount Kisco, New York, United States, 10549

Not Yet Recruiting

38

Laura & Isaac Perlmutter Cancer Center - NYU ACC

New York, New York, United States, 10016

Actively Recruiting

39

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

40

NYU Langone Faculty Group Practice

New York, New York, United States, 10016

Actively Recruiting

41

NYU Langone Medical Center (Tisch Hospital)

New York, New York, United States, 10016

Actively Recruiting

42

Memorial Sloan Kettering Cancer Center 53rd street.

New York, New York, United States, 10022

Actively Recruiting

43

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

44

Columbia University Medical Center - Neurological Institute of New York

New York, New York, United States, 10032

Actively Recruiting

45

CUIMC Research Pharmacy

New York, New York, United States, 10032

Actively Recruiting

46

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, United States, 10065

Actively Recruiting

47

MSK Nassau.

Uniondale, New York, United States, 11553

Actively Recruiting

48

Cleveland Clinic Taussig Cancer Center Investigational Pharmacy

Cleveland, Ohio, United States, 44106

Actively Recruiting

49

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States, 44195

Actively Recruiting

50

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States, 97213

Actively Recruiting

51

Providence Portland Medical Center

Portland, Oregon, United States, 97213

Actively Recruiting

52

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Not Yet Recruiting

53

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Actively Recruiting

54

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

55

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Actively Recruiting

56

University of Washington Medical Center

Seattle, Washington, United States, 98195

Actively Recruiting

57

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States, 53718

Actively Recruiting

58

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States, 53792

Actively Recruiting

59

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Actively Recruiting

60

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Actively Recruiting

61

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Actively Recruiting

62

ANIMI - Unidade de Tratamento Oncologico

Lages, Santa Catarina, Brazil, 88501001

Actively Recruiting

63

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

São Caetano do Sul, São Paulo, Brazil, 09541-270

Actively Recruiting

64

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

São Caetano do Sul, São Paulo, Brazil

Actively Recruiting

65

IBCC - Núcleo de Pesquisa e Ensino

São Paulo, Brazil, 04014-002

Actively Recruiting

66

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Actively Recruiting

67

Alberta Health Services and The Governors of The University of Alberta

Edmonton, Alberta, Canada, T6G 2C8

Actively Recruiting

68

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

69

Sunnybrook Research Institute

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

70

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

71

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

72

McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

73

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

Québec, Quebec, Canada, G1J 1Z4

Actively Recruiting

74

Fujian Cancer Hospital

Fuzhou, Fujian, China, 350014

Not Yet Recruiting

75

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

76

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

77

Rabin Medical Center

Petah Tikva, Central District, Israel, 4941492

Actively Recruiting

78

Sheba Medical Center

Ramat Gan, Central District, Israel, 5265601

Actively Recruiting

79

Hadassah Medical Center

Jerusalem, Jerusalem, Israel, 9112001

Not Yet Recruiting

80

Soroka Medical Center

Beersheba, Southern District, Israel, 8410101

Actively Recruiting

81

Sourasky Medical Center

Tel Aviv, TELL ABĪB, Israel, 6423906

Actively Recruiting

82

National Cancer Center Hospital East

Kashiwa, Chiba, Japan, 277-8577

Actively Recruiting

83

Kansai Medical University Hospital

Hirakata, Osaka, Japan, 573-1191

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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