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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05538130
Other study ID # C4901001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 30, 2022
Est. completion date September 28, 2028

Study information

Verified date May 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 124
Est. completion date September 28, 2028
Est. primary completion date March 28, 2027
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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)

Study Design


Intervention

Drug:
PF-07799544
Tablet
PF-07799933
Tablet
encorafenib
Capsule

Locations

Country Name City State
Canada Cross Cancer Institute Edmonton Alberta
Canada Jewish General Hospital Montreal Quebec
Canada McGill University Health Centre Montréal Quebec
Canada The Ottawa Hospital - General Campus Ottawa Ontario
Canada Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus Quebec City Quebec
Canada Princess Margaret Cancer Centre Toronto Ontario
Canada Sunnybrook Research Institute Toronto Ontario
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Cleveland Clinic Taussig Cancer Center Investigational Pharmacy Cleveland Ohio
United States Brigitte Harris Cancer Pavilion Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Highlands Oncology Group Fayetteville Arkansas
United States Highlands Oncology Group, PA Fayetteville Arkansas
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Columbia University Irving Medical Center New York New York
United States CUIMC Research Pharmacy New York New York
United States Providence Cancer Institute Franz Clinic Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Highlands Oncology Group Rogers Arkansas
United States Highlands Oncology Group, PA Rogers Arkansas
United States Fred Hutchinson Cancer Center Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Highlands Oncology Springdale Arkansas
United States Highlands Oncology Group Springdale Arkansas
United States Highlands Oncology Group, PA Springdale Arkansas
United States Florida Eye Center at Florida Medical Clinic Tampa Florida
United States Moffitt Cancer Center Tampa Florida
United States Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center Tampa Florida
United States Moffitt McKinley Hospital Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with dose limiting toxicities (DLTs) Phase 1a monotherapy and Phase 1b combination therapy dose escalation 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)
Primary Overall response rate (ORR) (phase 1b expansion) Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Baseline to 2 years
Primary Number of participants with treatment-emergent adverse events (AEs) (phase 1a and 1b dose escalation phases) AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy Baseline to 28 days after last dose of study medication
Primary Number of participants with clinically significant change from baseline in laboratory abnormalities (phase 1a and phase 1b dose escalation phase) Laboratory abnormalities as characterized by type, frequency, severity, and timing. Baseline to 28 days after last dose of study treatment
Primary Number of participants with clinically significant change from baseline in vital sign abnormalities (phase 1a and phase 1b dose escalation phase) Vital sign abnormalities as characterized by type, frequency, severity, and timing. Baseline to 28 days after last dose of study treatment
Primary Number of participants with clinically significant change from baseline in physical exam abnormalities (phase 1a and phase 1b dose escalation phase) 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
Secondary Number of participants with treatment-emergent adverse events (AEs) AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy Baseline to 2 years
Secondary Number of participants with clinically significant change from baseline in laboratory abnormalities Laboratory abnormalities as characterized by type, frequency, severity, and timing. Baseline to 2 years
Secondary Number of participants with clinically significant change from baseline in vital sign abnormalities Vital sign abnormalities as characterized by type, frequency, severity, and timing. Baseline to 2 years
Secondary PK parameters of PF-07799544, Single dose, maximum observed concentration (Cmax) PK parameters of PF-07799544, Single dose, Cmax Baseline to 2 years
Secondary PK parameters of PF-07799544, Single dose, time to maximum plasma concentration (Tmax) PK parameters of PF-07799544, Single dose, Tmax Baseline to 2 years
Secondary 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) PK parameters of PF-07799544, Single dose, AUClast Baseline to 2 years
Secondary PK parameters of PF-07799544, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) PK parameters of PF-07799544, Single dose, AUCinf Baseline to 2 years
Secondary PK parameters of PF-07799544, Single dose, terminal elimination half life (t½) PK parameters of PF-07799544, Single dose, t½ Baseline to 2 years
Secondary PK parameters of PF-07799544, Single dose, apparent oral clearance (CL/F) PK parameters of PF-07799544, Single dose, CL/F Baseline to 2 years
Secondary PK parameters of PF-07799544, Single dose, apparent volume of distribution (Vz/F) PK parameters of PF-07799544, Single dose, Vz/F Baseline to 2 years
Secondary PK parameters of PF-07799544, Multiple dose, maximum observed concentration (Cmax) PK parameters of PF-07799544, Multiple dose, Cmax Baseline to 2 years
Secondary PK parameters of PF-07799544, Multiple dose, time to maximum plasma concentration (Tmax) PK parameters of PF-07799544, Multiple dose, Tmax Baseline to 2 years
Secondary PK parameters of PF-07799544, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCt) PK parameters of PF-07799544, Multiple dose, AUCt Baseline to 2 years
Secondary PK parameters of PF-07799544, Multiple dose, terminal elimination half life (t½) PK parameters of PF-07799544, Multiple dose, t½ Baseline to 2 years
Secondary PK parameters of PF-07799544, Multiple dose, apparent oral clearance (CL/F) PK parameters of PF-07799544, Multiple dose, CL/F Baseline to 2 years
Secondary PK parameters of PF-07799544, Multiple dose, apparent volume of distribution (Vz/F) PK parameters of PF-07799544, Multiple dose, Vz/F Baseline to 2 years
Secondary PK parameters of PF-07799933, Single dose, maximum observed concentration (Cmax) PK parameters of PF-07799933, Single dose, Cmax Baseline to 2 years
Secondary PK parameters of PF-07799933, Single dose, time to maximum plasma concentration (Tmax) PK parameters of PF-07799933, Single dose, Tmax Baseline to 2 years
Secondary 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) PK parameters of PF-07799933, Single dose, AUClast Baseline to 2 years
Secondary PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) PK parameters of PF-07799933, Single dose, AUCinf Baseline to 2 years
Secondary PK parameters of PF-07799933, Single dose, terminal elimination half life (t½) PK parameters of PF-07799933, Single dose, t½ Baseline to 2 years
Secondary PK parameters of PF-07799933, Single dose, apparent oral clearance (CL/F) PK parameters of PF-07799933, Single dose, CL/F Baseline to 2 years
Secondary PK parameters of PF-07799933, Single dose, apparent volume of distribution (Vz/F) PK parameters of PF-07799933, Single dose, Vz/F Baseline to 2 years
Secondary PK parameters of PF-07799933, Multiple dose, maximum observed concentration (Cmax) PK parameters of PF-07799933, Multiple dose, Cmax Baseline to 2 years
Secondary PK parameters of PF-07799933, Multiple dose, time to maximum plasma concentration (Tmax) PK parameters of PF-07799933, Multiple dose, Tmax Baseline to 2 years
Secondary PK parameters of PF-07799933, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCt) PK parameters of PF-07799933, Multiple dose, AUCt Baseline to 2 years
Secondary PK parameters of PF-07799933, Multiple dose, terminal elimination half life (t½) PK parameters of PF-07799933, Multiple dose, t½ Baseline to 2 years
Secondary PK parameters of PF-07799933, Multiple dose, apparent oral clearance (CL/F) PK parameters of PF-07799933, Multiple dose, CL/F Baseline to 2 years
Secondary PK parameters of PF-07799933, Multiple dose, apparent volume of distribution (Vz/F) PK parameters of PF-07799933, Multiple dose, Vz/F Baseline to 2 years
Secondary ORR (phase 1a and phase 1b dose escalation) ORR as assessed using the RECIST version 1.1. Baseline to 2 years
Secondary Duration of response overall and in CNS Baseline to 2 years
Secondary Intracranial response (phase 1b Part 2) Intracranial response by RECIST version 1.1 (for brain metastases) Baseline to 2 years
Secondary PFS Baseline to 2 years
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