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NCT05355701 Clinical Trial

A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.

Melanoma Clinical Trial

Official title:
A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05355701
Other study ID # C4761001
Secondary ID BRAF Class 2
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 5, 2022
Est. completion date February 13, 2029

Study information
Verified date June 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 about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines (called binimetinib) in people with solid tumors. This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "BRAF" and available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine: - People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day. - People with colorectal cancer may also receive cetuximab. Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV). 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 156
Est. completion date February 13, 2029
Est. primary completion date August 13, 2027
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility This study is seeking participants who meet the following eligibility criteria: Inclusion Criteria: - Diagnosis of advanced/metastatic solid tumor including primary brain tumor. - Qualifying BRAF alteration (V600 or non-V600 Class II/Class III BRAF alteration), in tumor tissue and/or blood (ie circulating tumor deoxyribonucleic acid [DNA], or ctDNA). - Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1 and Part 2). - Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies Exclusion Criteria: - Brain metastasis larger than 4 cm - Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment. - For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PF-07799933
Tablet
• binimetinib
Tablet
Biological:
• cetuximab
Injection for intravenous use

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 Princess Margaret Cancer Centre Toronto Ontario
Israel Rambam Health Care Campus Haifa ?eifa
Israel Hadassah Medical Center Jerusalem Yerushalayim
Israel Rabin Medical Center Petah Tikva Hamerkaz
Israel Sheba Medical Center Ramat Gan Hamerkaz
Israel Sourasky Medical Center Tel Aviv Tell Abib
Israel Sourasky Medical Center Tel Aviv, Yaffo Hamerkaz
United States Clinical And Translational Research Center Aurora Colorado
United States Clinical and Translational Research Center (CTRC) Aurora Colorado
United States UCHealth Sue Anschutz-Rodgers Eye Center Aurora Colorado
United States University of Colorado Anschutz Medical Campus Aurora Colorado
United States University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) Aurora Colorado
United States University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) Aurora Colorado
United States University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) Aurora Colorado
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Cleveland Clinic Cleveland Ohio
United States Cleveland Clinic Taussig Cancer Center Investigational Pharmacy Cleveland Ohio
United States Cleveland Clinic Taussing 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 University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida
United States University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida
United States MSK Monmouth Middletown New Jersey
United States Sarah Cannon Research Institute - Pharmacy Nashville Tennessee
United States Tennessee Oncology PLLC Nashville Tennessee
United States Tennessee Oncology, PLLC Nashville Tennessee
United States TriStar Bone Marrow Transplant Nashville Tennessee
United States TriStar Centennial Medical center Nashville Tennessee
United States TriStar Centennial Medical Center - Cell Processing Lab Nashville Tennessee
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Cancer Center 53rd street New York New York
United States MSK David H. Koch Center for Cancer Care New York New York
United States DFCI Chestnut Hill Newton Massachusetts
United States Henry Ford Medical Center - Columbus Novi Michigan
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 South Texas Accelerated Research Therapeutics (START) San Antonio Texas
United States Highlands Oncology Group Springdale Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with dose limiting toxicities (DLTs) (Part 1 and Part 2) DLTs will be evaluated during the first cycle (21 days) as both a single agent or in combination with binimetinib or cetuximab Cycle 1 (21 days)
Primary Number of participants with treatment-emergent adverse events (AEs) (Part 1 and Part 2) 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 (Part 1 and Part 2) 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 (Part 1 and Part 2) Vital sign abnormalities as characterized by type, frequency, severity, and timing Baseline to 28 days after last dose of study treatment
Primary Dose interruptions due to AEs (Part 1 and Part 2) Incidence of dose interruptions due to AEs Baseline to 2 years
Primary Dose dose modifications due to AEs (Part 1 and Part 2) Incidence of dose modifications due to AEs Baseline to 2 years
Primary Discontinuations due to AEs (Part 1 and Part 2) Incidence of discontinuations due to AEs Baseline to 2 years
Primary MTD (Part 1 and Part 2) Maximum tolerated dose (MTD) Cycle 1 (21 days)
Primary RDE (Part 1 and Part 2) Recommended dose for expansion (RDE) Cycle 1 (21 days)
Primary Overall response rate (ORR) (Part 3) 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 clinically significant physical exam abnormalities (Part 1 and Part 2) 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 Part 1 and Part 2: ORR ORR as assessed using the RECIST version 1.1. Baseline to 2 years
Secondary Part 1/2/3: Intracranial response Intracranial response by RECIST version 1.1 (for brain metastases) & Response Assessment in Neuro-Oncology (RANO) - for primary brain tumors). Baseline to 2 years
Secondary Part 1 and Part 2: Duration of response Duration of response Baseline to 2 years
Secondary Part 3: 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 Part 3: 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 Part 3: 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 Part 3: Dose interruptions due to AEs Incidence of dose interruptions due to AEs Baseline to 2 years
Secondary Part 3: Dose dose modifications due to AEs Incidence of dose modifications due to AEs Baseline to 2 years
Secondary Part 3: Discontinuations due to AEs Incidence of discontinuations due to AEs Baseline to 2 years
Secondary Part 3: Time to event endpoints in each combination Time to event endpoints in each combination Baseline to 2 years
Secondary Part 3: Disease Control Rate (DCR) DCR Baseline to 2 years
Secondary Part 1/2/3: PK parameters of PF-07799933, Single dose, maximum observed concentration (Cmax) PK parameters of PF-07799933, Single dose, Cmax Baseline to 2 years
Secondary Part 1/2/3: 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 Part 1/2/3: 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 Part 1/2/3: PK parameters of PF-07799933, Single dose, area under plasma concentration-time curve over 24 hours (AUC24) PK parameters of PF-07799933, Single dose, AUC24 Baseline to 2 years
Secondary Part 1/2/3: PK parameters of PF-07799933, Single dose, area under plasma concentration-time curve over 48 hours (AUC48) PK parameters of PF-07799933, Single dose, AUC48 Baseline to 2 years
Secondary Part 1/2/3: 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 Part 1/2/3: 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 Part 1/2/3: 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 Part 1/2/3: 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 Part 1/2/3: PK parameters of PF-07799933, Multiple dose, maximum observed concentration (Cmax) PK parameters of PF-07799933, Multiple dose, Cmax Baseline to 2 years
Secondary Part 1/2/3: PK parameters of PF-07799933, Multiple dose, trough plasma or serum concentration (Ctrough) PK parameters of PF-07799933, Multiple dose, Ctrough Baseline to 2 years
Secondary Part 1/2/3: 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 Part 1/2/3: 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 Part 1/2/3: PK parameters of PF-07799933, Multiple dose, CL/F PK parameters of PF-07799933, Multiple dose, CL/F Baseline to 2 years
Secondary Part 1/2/3: PK parameters of PF-07799933, Multiple dose, average plasma concentration (Cav) PK parameters of PF-07799933, Multiple dose, Cav Baseline to 2 years
Secondary Part 1/2/3: PK parameters of PF-07799933, Multiple dose, peak-to-trough ratio (PTR) PK parameters of PF-07799933, Multiple dose, PTR Baseline to 2 years
Secondary Part 1/2/3: PK parameters of PF-07799933, Multiple dose, accumulation ratio (Rac) PK parameters of PF-07799933, Multiple dose, Rac (AUCt /AUCsd,t) Baseline to 2 years
Secondary Part 1/2/3: PK parameters of PF-07799933, Multiple dose, t1/2 PK parameters of PF-07799933, Multiple dose, t1/2 Baseline to 2 years
Secondary Part 1/2/3: PK parameters of PF-07799933, Multiple dose, Vz/F PK parameters of PF-07799933, Multiple dose, Vz/F Baseline to 2 years
Secondary Part 3: PK parameters of cytochrome P450 (CYP)3A4 probe substrate midazolam, Cmax PK parameters of CYP3A4 probe substrate midazolam, Cmax Baseline to 2 years
Secondary Part 3: PK parameters of CYP3A4 probe substrate midazolam, Tmax PK parameters of CYP3A4 probe substrate midazolam, Tmax Baseline to 2 years
Secondary Part 3: PK parameters of CYP3A4 probe substrate midazolam, AUClast PK parameters of CYP3A4 probe substrate midazolam, AUClast Baseline to 2 years
Secondary Part 3: PK parameters of CYP3A4 probe substrate midazolam, t½ PK parameters of CYP3A4 probe substrate midazolam, t½ Baseline to 2 years
Secondary Part 3: PK parameters of CYP3A4 probe substrate midazolam, AUCinf PK parameters of CYP3A4 probe substrate midazolam, AUCinf Baseline to 2 years
Secondary Part 3: PK parameters of CYP3A4 probe substrate midazolam, CL/F PK parameters of CYP3A4 probe substrate midazolam, CL/F Baseline to 2 years
Secondary Part 3: PK parameters of CYP3A4 probe substrate midazolam, Vz/F PK parameters of CYP3A4 probe substrate midazolam, Vz/F Baseline to 2 years
Secondary Part 3: TTR Time to response (TTR) Baseline to 2 years
Secondary Part 3: DOR Duration of response (DOR) Baseline to 2 years
Secondary Part 3: PFS Progression-free survival (PFS) Baseline to 2 years
Secondary Part 3: OS Overall survival (OS) Baseline to 2 years
Secondary Number of participants with clinically significant physical exam abnormalities (Part 3) Physical exam abnormalities as as graded by NCI CTCAE version 5.0 Baseline to 28 days after last dose of study medication
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