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A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Sponsor: Seagen, a wholly owned subsidiary of Pfizer
Summary
This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer. This study will have seven groups or "parts." * Part A will find out how much SEA-CD70 should be given to participants * Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with MDS. * Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with AML. * Part D will find out how much SEA-CD70 with azacitidine should be given to participants * Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML that has not been treated. * Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS/AML. * Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.
Official title: A Phase 1 Study of SEA-CD70 in Myeloid Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
178
Start Date
2020-08-07
Completion Date
2028-07-03
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
SEA-CD70
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle
azacitidine
75mg/m\^2 injected under the skin (SC; subcutaneous) or given into the vein (IV; intravenously) on Days 1 through 7 of each treatment cycle.
Venetoclax
400 mg /day PO, continuously; administered with ramping
Locations (54)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Dept. of Medicine, UAB ONeal Comprehensive Cancer Center
Birmingham, Alabama, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Hematology-Oncology Clinic
Los Angeles, California, United States
Colorado Blood Cancer Institute, Lab
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Presbyterian/St. Luke's Medical Center
Denver, Colorado, United States
The University of Kansas Cancer Center ,Investigational Drug Services
Fairway, Kansas, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, United States
University of Kansas Medical center Medical office building
Kansas City, Kansas, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
The University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Norton Hospitals, Inc
Louisville, Kentucky, United States
Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD
Louisville, Kentucky, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
Norton Women & Children's Hospital
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber/Mass General Brigham Cancer Care, Inc
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
The University of Kansas Cancer Center - Medical Oncology Clinic
Kansas City, Missouri, United States
The University of Kansas Cancer Center - Radiation Oncology Clinic
Kansas City, Missouri, United States
The University of Kansas Cancer Center -North
Kansas City, Missouri, United States
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
Columbia University Irving Medical Center
New York, New York, United States
CUIMC Research Pharmacy
New York, New York, United States
The New York and Presbyterian Hospital
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center/James Cancer Hospital
Columbus, Ohio, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Medical University of South Carolina- Ashley River Tower
Charleston, South Carolina, United States
Medical University of South Carolina- Investigational Drug Services
Charleston, South Carolina, United States
Medical University of South Carolina- University Hospital
Charleston, South Carolina, United States
Baylor Research Institute
Dallas, Texas, United States
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
Yamagata University Hospital
Yamagata, Japan
Pharmacy - UMC Utrecht t.a.v. Apotheek KGO
Utrecht, Netherlands
University Medical Center (UMC) Utrecht
Utrecht, Netherlands