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 ADVANCED SOLID TUMORS

Status: Recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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)

Locations
United States
Alabama
The Kirklin Clinic of UAB Hospital
NOT_YET_RECRUITING
Birmingham
The University of Alabama at Birmingham
NOT_YET_RECRUITING
Birmingham
University of Alabama at Birmingham - Phase I Clinical Trials Unit
NOT_YET_RECRUITING
Birmingham
Arkansas
Highlands Oncology Group
RECRUITING
Fayetteville
Highlands Oncology Group
RECRUITING
Rogers
Highlands Oncology Group, PA
RECRUITING
Springdale
California
The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate
NOT_YET_RECRUITING
Los Angeles
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
NOT_YET_RECRUITING
Santa Monica
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
RECRUITING
Tampa
Moffitt McKinley Hospital
RECRUITING
Tampa
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Michigan
Brigitte Harris Cancer Pavilion
RECRUITING
Detroit
Henry Ford Hospital
RECRUITING
Detroit
Minnesota
HealthPartners Frauenshuh Cancer Center
NOT_YET_RECRUITING
Saint Louis Park
Methodist Hospital Inpatient Pharmacy
NOT_YET_RECRUITING
Saint Louis Park
HealthPartners Cancer Center at regions Hospital
NOT_YET_RECRUITING
Saint Paul
Regions Hospital Pharmacy
NOT_YET_RECRUITING
Saint Paul
New Jersey
MSK Basking Ridge.
RECRUITING
Basking Ridge
MSK Monmouth.
RECRUITING
Middletown
MSK Bergen.
RECRUITING
Montvale
New York
Optum Medical Care, PC
NOT_YET_RECRUITING
Brewster
MSK Commack.
RECRUITING
Commack
MSK Westchester.
RECRUITING
Harrison
Columbia University Irving Medical Center
RECRUITING
New York
Columbia University Medical Center - Neurological Institute of New York
RECRUITING
New York
CUIMC Research Pharmacy
RECRUITING
New York
Memorial Sloan Kettering Cancer Center - Main Campus
RECRUITING
New York
Memorial Sloan Kettering Cancer Center 53rd street.
RECRUITING
New York
Brooklyn Radiation Oncology, PC
NOT_YET_RECRUITING
Richmond Hill
MSK Nassau.
RECRUITING
Uniondale
Clinical Research Alliance
NOT_YET_RECRUITING
Westbury
Ohio
Cleveland Clinic Taussig Cancer Center
RECRUITING
Cleveland
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
RECRUITING
Cleveland
Oregon
Providence Cancer Institute Franz Clinic
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Tennessee
Sarah Cannon Research Institute- Pharmacy
RECRUITING
Nashville
SCRI Oncology Partners
RECRUITING
Nashville
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
University of Washington Medical Center
RECRUITING
Seattle
Other Locations
Australia
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Royal Melbourne Hospital
RECRUITING
Parkville
Canada
Cross Cancer Institute
RECRUITING
Edmonton
Jewish General Hospital
RECRUITING
Montreal
McGill University Health Centre
RECRUITING
Montreal
The Ottawa Hospital - General Campus
RECRUITING
Ottawa
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
RECRUITING
Québec
Princess Margaret Cancer Centre
RECRUITING
Toronto
Sunnybrook Research Institute
RECRUITING
Toronto
Israel
Soroka Medical Center
RECRUITING
Beersheba
Hadassah Medical Center
NOT_YET_RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Sourasky Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-11-30
Estimated Completion Date: 2028-10-11
Participants
Target number of participants: 124
Treatments
Experimental: Monotherapy Dose Escalation (Phase 1a)
Participants will receive PF-07799544
Experimental: Phase 1b Substudy B Combination Dose Escalation
Participants will receive PF-07799544 and PF-07799933
Experimental: Phase 1b Substudy B Combination Dose Expansion
Participants will receive PF-07799544 and PF-07799933
Experimental: Phase 1b Substudy C Combination Dose Expansion
Participants will receive PF-07799544 and PF-07799933
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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