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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05538130 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).
Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have:
All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.
Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a Monotherapy Dose Escalation | Experimental | Participants will receive PF-07799544 |
|
| Phase 1b Combination Dose Escalation | Experimental | Participants will receive PF-07799544 and PF-07799933 |
|
| Phase 1b Combination Dose Expansion | Experimental | Participants will receive PF-07799544 and PF-07799933 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07799544 | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs) | 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) |
| Phase 1a monotherapy and Phase 1b combination dose escalation: 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 28 days after last dose of study medication |
| Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities | Laboratory abnormalities as characterized by type, frequency, severity, and timing. | Baseline to 28 days after last dose of study treatment |
| Phase 1a monotherapy and Phase 1b combination dose escalation: 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 28 days after last dose of study treatment |
| Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities | 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 |
| Phase 1b Dose Expansion: Overall response rate (ORR) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a monotherapy and Phase 1b combination dose escalation: ORR | ORR as assessed using the RECIST version 1.1. | Baseline to 2 years |
| Phase 1b Dose Expansion: Number of participants with treatment-emergent adverse events (AEs) |
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Phase 1b Inclusion Criteria:
Phase 1b Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic of UAB Hospital | Recruiting | Birmingham | Alabama | 35233 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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|
| PF-07799933 | Drug | Tablet |
|
|
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors |
| Baseline to 2 years |
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
| Baseline to 2 years |
| Phase 1b Dose Expansion: 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 |
| Phase 1b Dose Expansion: 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 |
| Phase 1b Dose Expansion: Duration of Response (Overall and in CNS) | Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors | Baseline to 2 years |
| Phase 1b Dose Expansion: Intracranial response | Intracranial response by RECIST version 1.1 (for brain metastases) | Baseline to 2 years |
| Phase 1b Dose Expansion: Progression Free Survival (PFS) | Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors | Baseline to 2 years |
| PK Parameters: Maximum Observed Concentration (Cmax) | Single dose and multiple dose PK will be calculated as data permits | Baseline to 2 years |
| PK Parameters: Maximum Plasma Concentration (Tmax) | Single dose and multiple dose PK will be calculated as data permits | Baseline to 2 years |
| PK Parameters: Area Under Curve (AUC) | Single dose and multiple dose PK will be calculated as data permits | Baseline to 2 years |
| PK Parameters: terminal elimination half-life (t½) | Singe dose and multiple dose PK will be calculated as data permits | Baseline to 2 years |
| PK Parameters: Apparent Oral Clearance (CL/F) | Singe dose and multiple dose PK will be calculated as data permits | Baseline to 2 years |
| PK Parameters: Apparent Volume of Distribution (Vz/F) | Singe dose and multiple dose PK will be calculated as data permits | Baseline to 2 years |
| The University of Alabama at Birmingham |
| Recruiting |
| Birmingham |
| Alabama |
| 35249 |
| United States |
| University of Alabama at Birmingham - Phase I Clinical Trials Unit | Recruiting | Birmingham | Alabama | 35249 | United States |
| Highlands Oncology Group, PA | Recruiting | Fayetteville | Arkansas | 72703 | United States |
| Highlands Oncology Group, PA | Recruiting | Rogers | Arkansas | 72758 | United States |
| Highlands Oncology Group, PA | Recruiting | Springdale | Arkansas | 72762 | United States |
| The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate | Recruiting | Los Angeles | California | 90025 | United States |
| Keck Hospital of USC | Not yet recruiting | Los Angeles | California | 90033 | United States |
| Los Angeles General Medical Center | Not yet recruiting | Los Angeles | California | 90033 | United States |
| USC/Norris Comprehensive Cancer Center | Not yet recruiting | Los Angeles | California | 90033 | United States |
| Keck Medical Center of USC Pasadena | Not yet recruiting | Pasadena | California | 91105 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting | San Francisco | California | 94143 | United States |
| UCSF Helen Diller Medical Center at Parnassus Heights | Recruiting | San Francisco | California | 94143 | United States |
| UCSF Medical Center, Investigational Pharmacy | Recruiting | San Francisco | California | 94158 | United States |
| The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only) | Recruiting | Santa Monica | California | 90404 | United States |
| Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center | Recruiting | Tampa | Florida | 33612 | United States |
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| Moffitt McKinley Hospital | Recruiting | Tampa | Florida | 33612 | United States |
| Ochsner Clinic Foundation | Not yet recruiting | New Orleans | Louisiana | 70121 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Ophthalmic Consultants of Boston Inc (OCB) | Recruiting | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Mass General Waltham | Recruiting | Waltham | Massachusetts | 02451 | United States |
| Brigitte Harris Cancer Pavilion | Recruiting | Detroit | Michigan | 48202 | United States |
| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
| HealthPartners Frauenshuh Cancer Center | Not yet recruiting | Saint Louis Park | Minnesota | 55426 | United States |
| Methodist Hospital Inpatient Pharmacy | Not yet recruiting | Saint Louis Park | Minnesota | 55426 | United States |
| HealthPartners Cancer Center at regions Hospital | Not yet recruiting | Saint Paul | Minnesota | 55101 | United States |
| Regions Hospital Pharmacy | Not yet recruiting | Saint Paul | Minnesota | 55101 | United States |
| MSK Basking Ridge. | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
| MSK Monmouth. | Recruiting | Middletown | New Jersey | 07748 | United States |
| MSK Bergen. | Recruiting | Montvale | New Jersey | 07645 | United States |
| Optum Medical Care, PC | Not yet recruiting | Brewster | New York | 10509 | United States |
| MSK Commack. | Recruiting | Commack | New York | 11725 | United States |
| MSK Westchester. | Recruiting | Harrison | New York | 10604 | United States |
| Optum Medical Care, PC | Not yet recruiting | Mount Kisco | New York | 10549 | United States |
| Laura & Isaac Perlmutter Cancer Center - NYU ACC | Recruiting | New York | New York | 10016 | United States |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
| NYU Langone Faculty Group Practice | Recruiting | New York | New York | 10016 | United States |
| NYU Langone Medical Center (Tisch Hospital) | Recruiting | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center 53rd street. | Recruiting | New York | New York | 10022 | United States |
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
| Columbia University Medical Center - Neurological Institute of New York | Recruiting | New York | New York | 10032 | United States |
| CUIMC Research Pharmacy | Recruiting | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center - Main Campus | Recruiting | New York | New York | 10065 | United States |
| MSK Nassau. | Recruiting | Uniondale | New York | 11553 | United States |
| Cleveland Clinic Taussig Cancer Center Investigational Pharmacy | Recruiting | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Taussig Cancer Center | Recruiting | Cleveland | Ohio | 44195 | United States |
| Providence Cancer Institute Franz Clinic | Recruiting | Portland | Oregon | 97213 | United States |
| Providence Portland Medical Center | Recruiting | Portland | Oregon | 97213 | United States |
| UPMC Hillman Cancer Center | Not yet recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Recruiting | Seattle | Washington | 98195 | United States |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center | Recruiting | Madison | Wisconsin | 53718 | United States |
| University of Wisconsin Carbone Cancer Center - University Hospital | Recruiting | Madison | Wisconsin | 53792 | United States |
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
| Royal Melbourne Hospital | Recruiting | Parkville | Victoria | 3050 | Australia |
| Hospital Nossa Senhora da Conceição | Recruiting | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| ANIMI - Unidade de Tratamento Oncologico | Recruiting | Lages | Santa Catarina | 88501001 | Brazil |
| Centro de Oncologia - CEON+ - Unidade São Caetano do Sul | Recruiting | São Caetano do Sul | 09541-270 | Brazil |
| IBCC - Núcleo de Pesquisa e Ensino | Recruiting | São Paulo | 04014-002 | Brazil |
| Cross Cancer Institute | Recruiting | Edmonton | Alberta | T6G 1Z2 | Canada |
| Alberta Health Services and The Governors of The University of Alberta | Recruiting | Edmonton | Alberta | T6G 2C8 | Canada |
| The Ottawa Hospital - General Campus | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Research Institute | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus | Recruiting | Québec | Quebec | G1J 1Z4 | Canada |
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
| Rabin Medical Center | Recruiting | Petah Tikva | Central District | 4941492 | Israel |
| Sheba Medical Center | Recruiting | Ramat Gan | Central District | 5265601 | Israel |
| Hadassah Medical Center | Not yet recruiting | Jerusalem | Jerusalem | 9112001 | Israel |
| Soroka Medical Center | Recruiting | Beersheba | Southern District | 8410101 | Israel |
| Sourasky Medical Center | Recruiting | Tel Aviv | TELL ABĪB | 6423906 | Israel |
| National Cancer Center Hospital East | Recruiting | Kashiwa | Chiba | 277-8577 | Japan |
| Kansai Medical University Hospital | Recruiting | Hirakata | Osaka | 573-1191 | Japan |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D005910 | Glioma |
| D013964 | Thyroid Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D009375 | Neoplasms, Glandular and Epithelial |
| D004701 | Endocrine Gland Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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