About this trial
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
Qualifiers
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
Disqualifiers
Previous exposure to CD70-targeted agents
Prior allogeneic hematopoietic stem cell transplant, for any condition
Central nervous system leukemia
History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura
Trial design
Treatments tested in this trial
- SEA-CD70
- azacitidine
- Venetoclax
Treatment groups
7
Treatment groupsSee each treatment group below.