Condition: Myelodysplastic Syndrome · Acute Myeloid Leukemia · Sponsor: Seagen, a wholly owned subsidiary of Pfizer
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.
This description comes directly from the study's public registry record.
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| University of Alabama at Birmingham | Birmingham, Alabama, United States | Active Not Recruiting |
| University of Alabama at Birmingham | Birmingham, Alabama, United States | Active Not Recruiting |
| Dept. of Medicine, UAB ONeal Comprehensive Cancer Center | Birmingham, Alabama, United States | Active Not Recruiting |
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Duarte, California, United States | Recruiting |
| IP Address: City of Hope Investigational Drug Services(IDS) | Duarte, California, United States | Recruiting |
| Ronald Reagan UCLA Medical Center | Los Angeles, California, United States | Recruiting |
| UCLA Hematology-Oncology Clinic | Los Angeles, California, United States | Recruiting |
| Colorado Blood Cancer Institute, Lab | Denver, Colorado, United States | Active Not Recruiting |
| Colorado Blood Cancer Institute | Denver, Colorado, United States | Active Not Recruiting |
| Presbyterian/St. Luke's Medical Center | Denver, Colorado, United States | Active Not Recruiting |
| The University of Kansas Cancer Center ,Investigational Drug Services | Fairway, Kansas, United States | Recruiting |
| The University of Kansas Clinical Research Center | Fairway, Kansas, United States | Recruiting |
+ 41 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04227847