Study of PF-07248144 in Advanced or Metastatic Solid Tumors
Start Date
11/16/2020
Completion Date
8/10/2029
Summary
This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with other agents
Detailed Description
Study has two parts, Part 1 (dose escalation) and Part 2 (dose expansion). Part 1 is divided into Parts 1A, 1B, 1C, 1D and 1E and Part 2 is divided into Parts 2A, 2B, 2D and 2E. In Part 1A, single escalating doses of PF-07248144 alone will be administered to determine the maximum tolerable dose (MTD) and select the recommended dose for expansion (RDE). In Part 1B, 1C, 1D and 1E PF-07248144 will be administered in combination with either fulvestrant (Part 1B); palbociclib + letrozole (Part 1C) or PF-07220060+fulvestrant (Part 1D) or vepdegestrant (Part 1E). After the determination of the monotherapy RDE in Part 1A, PF-07248144 will be evaluated in a dose expansion cohort as a monotherapy in Part 2A. After determination of the combination RDE from Part 1B, PF-07248144 in combination with fulvestrant, PF-07248144 will be evaluated in a combination dose expansion with fulvestrant in Part 2B. In Part 1C, PF-07248144 in combination with letrozole + palbociclib will be evaluated for dose finding to determine the MTD and RDE for this combination. After determination of the triple combination RDE from Part 1D, PF-07248144 in combination with PF-07220060 + fulvestrant will be evaluated in a combination dose-expansion cohort, Part 2D. After determination of the combination RDE from Part 1E, PF-07248144 in combination with vepdegestrant will be evaluated in a combination dose-expansion cohort, Part 2E.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PF-07248144
Fulvestrant
Letrozole
Palbociclib
PF-07220060
PF-07850327, ARV-471, vepdegestrant
Conditions
Locations
HonorHealth
Scottsdale, Arizona 85258
United States
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
UCSF Medical Center at Mission Bay
San Francisco, California 94158
United States
Smilow Cancer Hospital at Yale - New Haven
New Haven, Connecticut 06510
United States
Yale-New Haven Hospital- Yale Cancer Center
New Haven, Connecticut 06510
United States
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut 06511
United States
Yale University
New Haven, Connecticut 06511
United States
Holy Cross Hospital
Fort Lauderdale, Florida 33308
United States
St. Elizabeth Healthcare
Edgewood, Kentucky 41017
United States
University Medical Center, lnc.:DBA University of Louisville Hospital
Louisville, Kentucky 40202
United States
University of Louisville
Louisville, Kentucky 40202
United States
UofL Health Brown Cancer Center
Louisville, Kentucky 40202
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
MD Anderson The Woodlands
Conroe, Texas 77384
United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas 77030
United States
U.T. MD Anderson Cancer Center
Houston, Texas 77030
United States
MD Anderson West Houston
Houston, Texas 77079
United States
MD Anderson League City
League City, Texas 77573
United States
NEXT Oncology
San Antonio, Texas 78229
United States
MD Anderson
Sugar Land, Texas 77478
United States
Swedish Cancer Institute
Seattle, Washington 98104
United States
Swedish Medical Center
Seattle, Washington 98122
United States
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Australia
Cancer Research South Australia
Adelaide, South Australia 5000
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
Royal Melbourne Hospital
Parkville, Victoria 3050
Australia
Western Health-Sunshine & Footscray Hospitals
St Albans, Victoria 3021
Australia
St. John of God Subiaco Hospital
Subiaco, Western Australia 6008
Australia
Beijing Cancer hospital
Beijing, Beijing Municipality 100142
China
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong 510060
China
Jilin Province Tumor Hospital
Changchun, Jilin 130000
China
Jilin Province Tumor Hospital
Changchun, Jilin 132000
China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi 710061
China
Aichi Cancer Center Hospital
Nagoya, Aichi-ken 464-8681
Japan
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
Kanagawa cancer center
Yokohama, Kanagawa 2418515
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Japan
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul] 03722
South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 06351
South Korea
Kyungpook National University Chilgok Hospital
Daegu, Taegu-kwangyǒkshi 41404
South Korea
Asan Medical Center
Seoul, 05505
South Korea