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Brief Title: Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
Official Title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Study ID: NCT04152018
Brief Summary: Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC - clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B) and dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 3 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
HonorHealth Research Institute, Scottsdale, Arizona, United States
Scottsdale Healthcare Hospitals DBA HonorHealth, Scottsdale, Arizona, United States
Virginia G. Piper Cancer Pharmacy, Scottsdale, Arizona, United States
HonorHealth Scottsdale Shea Medical Center, Scottsdale, Arizona, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
UCLA Hematology Oncology, Los Angeles, California, United States
UCLA Hematology/Oncology, Los Angeles, California, United States
UCLA Hematology/Oncology, Santa Monica, California, United States
Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
Siteman Cancer Center - West County, Creve Coeur, Missouri, United States
Siteman Cancer Center - North County, Florissant, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine Siteman Cancer Center, Saint Louis, Missouri, United States
Siteman Cancer Center - South County, Saint Louis, Missouri, United States
Siteman Cancer Center - North County, Saint Louis, Missouri, United States
Siteman Cancer Center - St. Peters, Saint Peters, Missouri, United States
Monter Cancer Center, Lake Success, New York, United States
R.J. Zuckerberg Cancer Center, Lake Success, New York, United States
Duke Univ. Medical Center/Duke Cancer Center, Durham, North Carolina, United States
Investigational Chemotherapy Service, Durham, North Carolina, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
NEXT Oncology, San Antonio, Texas, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
Liverpool Hospital, Liverpool, New South Wales, Australia
Southern Medical Day Care Centre, Wollongong, New South Wales, Australia
Asan Medical Center, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Onkologicky ustav sv. Alzbety, s.r.o., Bratislava, , Slovakia
Univerzitna nemocnica Bratislava, Bratislava, , Slovakia
Narodny ustav srdcovych a cievnych chorob, a.s., Bratislava, , Slovakia
MR Poprad s.r.o., Komárno, , Slovakia
KARDIO, s.r.o., Poprad, , Slovakia
POKO Poprad, s.r.o., Ambulancia klinickej onkologie, Poprad, , Slovakia
Nemocnica Poprad a.s., Poprad, , Slovakia
MR Poprad s.r.o., Poprad, , Slovakia
Nemocnica Poprad a.s., Poprad, , Slovakia
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR