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NCT04227847
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Conditions: Myelodysplastic Syndrome, Acute Myeloid Leukemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 178
Sponsor: Seagen, a wholly owned subsidiary of Pfizer
Location: University of Alabama at Birmingham Birmingham Alabama
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.
Eligibility Criteria
Part A Inclusion Criteria
* Participants with cytologically/histologically confirmed MDS (2016 World Health Organization (WHO) classification) with
* Measurable disease per WHO MDS with excess blasts criteria
* MDS that is relapsed or refractory and must not have other therapeutic options
* Treatment failure after prior hypomethylating agent (HMA) therapy for MDS
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Part B Inclusion Criteria
* Participants with cytologically/histologically confirmed MDS (WHO classification) with:
* Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria
* MDS that is relapsed or refractory and must not have other therapeutic options
* Treatment failure after prior HMA therapy for MDS
* ECOG Performance Status of 0-2
Part C Inclusion Criteria
* Participants with relapsed or refractory AML (ICC 2022) (except for acute promyelocytic leukemia \[APL\]):
* Who have received either 2 or 3 previous regimens
* Who have received 1 previous regimen to treat active disease and have at least one of the following:
* Age \> 60 and ≤75 years.
* Primary resistant AML or secondary AML
* First CR duration \
Source: ClinicalTrials.gov (NCT04227847). StuddyBuddy aggregates publicly available trial information.