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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538130
• Other study ID #: C4901001
• Status: Recruiting
• Phase: Phase 1
• 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
• 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)

Related Conditions & MeSH terms

• Brain Neoplasms
• Colorectal Cancer
• Glioma
• Malignant Neoplasms
• Melanoma
• Neoplasms
• Non-Small Cell Lung Cancer
• Thyroid Cancer

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

External Links

•   To obtain contact information for a study center near you, click here.