Clinical trial NCT05538130: A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Melanoma
Glioma
Thyroid Cancer
Non-Small Cell Lung Cancer
Malignant Neoplasms
Brain Neoplasms
Colorectal Cancer
Keywords: Proto-Oncogene Proteins B-raf
Brain neoplasms
Melanoma
Carcinoma, Non-Small-Cell Lung
Neoplasm by Histologic Type
CRC
MAPK
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-09-13
Enrollment: 124
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 criteria: 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)

Primary outcomes:
measure: Number of participants with dose limiting toxicities (DLTs) Phase 1a monotherapy and Phase 1b combination therapy dose escalation
timeFrame: Cycle 1 (21 days)
measure: Overall response rate (ORR) (phase 1b expansion)
timeFrame: Baseline to 2 years
measure: Number of participants with treatment-emergent adverse events (AEs) (phase 1a and 1b dose escalation phases)
timeFrame: Baseline to 28 days after last dose of study medication
measure: Number of participants with clinically significant change from baseline in laboratory abnormalities (phase 1a and phase 1b dose escalation phase)
timeFrame: Baseline to 28 days after last dose of study treatment
measure: Number of participants with clinically significant change from baseline in vital sign abnormalities (phase 1a and phase 1b dose escalation phase)
timeFrame: Baseline to 28 days after last dose of study treatment
measure: Number of participants with clinically significant change from baseline in physical exam abnormalities (phase 1a and phase 1b dose escalation phase)
timeFrame: Baseline to 28 days after last dose of study treatment
Secondary outcomes:
measure: Number of participants with treatment-emergent adverse events (AEs)
timeFrame: Baseline to 2 years
measure: Number of participants with clinically significant change from baseline in laboratory abnormalities
timeFrame: Baseline to 2 years
measure: Number of participants with clinically significant change from baseline in vital sign abnormalities
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Single dose, maximum observed concentration (Cmax)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Single dose, time to maximum plasma concentration (Tmax)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Single dose, terminal elimination half life (t½)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Single dose, apparent oral clearance (CL/F)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Single dose, apparent volume of distribution (Vz/F)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Multiple dose, maximum observed concentration (Cmax)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Multiple dose, time to maximum plasma concentration (Tmax)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCτ)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Multiple dose, terminal elimination half life (t½)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Multiple dose, apparent oral clearance (CL/F)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799544, Multiple dose, apparent volume of distribution (Vz/F)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Single dose, maximum observed concentration (Cmax)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Single dose, time to maximum plasma concentration (Tmax)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Single dose, terminal elimination half life (t½)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Single dose, apparent oral clearance (CL/F)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Single dose, apparent volume of distribution (Vz/F)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Multiple dose, maximum observed concentration (Cmax)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Multiple dose, time to maximum plasma concentration (Tmax)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCτ)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Multiple dose, terminal elimination half life (t½)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Multiple dose, apparent oral clearance (CL/F)
timeFrame: Baseline to 2 years
measure: PK parameters of PF-07799933, Multiple dose, apparent volume of distribution (Vz/F)
timeFrame: Baseline to 2 years
measure: ORR (phase 1a and phase 1b dose escalation)
timeFrame: Baseline to 2 years
measure: Duration of response overall and in CNS
timeFrame: Baseline to 2 years
measure: Intracranial response (phase 1b Part 2)
timeFrame: Baseline to 2 years
measure: PFS
timeFrame: Baseline to 2 years
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group, PA
state: Arkansas
city: Tampa
country: United States
facility: Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt McKinley Hospital
state: Florida
city: Detroit
country: United States
facility: Brigitte Harris Cancer Pavilion
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Basking Ridge
country: United States
facility: MSK Basking Ridge.
state: New Jersey
city: Middletown
country: United States
facility: MSK Monmouth.
state: New Jersey
city: Montvale
country: United States
facility: MSK Bergen.
state: New Jersey
city: Brewster
country: United States
facility: Optum Medical Care, PC
state: New York
city: Commack
country: United States
facility: MSK Commack.
state: New York
city: Harrison
country: United States
facility: MSK Westchester.
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center 53rd street.
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center - Neurological Institute of New York
state: New York
city: New York
country: United States
facility: CUIMC Research Pharmacy
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center - Main Campus
state: New York
city: Richmond Hill
country: United States
facility: Brooklyn Radiation Oncology, PC
state: New York
city: Uniondale
country: United States
facility: MSK Nassau.
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Nashville
country: United States
facility: Sarah Cannon Research Institute- Pharmacy
state: Tennessee
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Quebec City
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
state: Quebec
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
state: Hadarom
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
state: Hamerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: Hamerkaz
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: