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A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Trial Status: active
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.
Inclusion 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 <6 months
- Adverse-risk per European Leukemia Network genetic risk stratification
- Age 18-75 years
- ECOG performance status of 0-2
Parts D and F Inclusion Criteria
- Participants with diagnosis of MDS or MDS/AML (ICC 2022 criteria)
- Disease which has relapsed, failed to respond after minimum of 6 cycles, or
progressed following an HMA in the immediately preceding line of therapy.
- Eligible for continued therapy with azacitidine
- ECOG Performance Status 0-2
Parts D and E Inclusion Criteria
- Participants with diagnosis of MDS or MDS/AML (ICC 2022 criteria), previously
untreated.
- Participants with higher-risk per IPSS-M MDS and MDS/AML
- ECOG Performance Status 0-2
Part G Inclusion Criteria
- Participants with diagnosis of AML (ICC 2022 criteria), previously untreated and
ineligible for standard induction chemotherapy.
- Age ≥18 years.
- ECOG Performance Status of 0-2.
Exclusion Criteria (All Parts)
- 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
- Parts D, F and G only: Prior oral HMA or oral HMA-combinations
- Part G: conditions that preclude enteral route of administration; concomitant use of
strong/moderate CYP3A inducers; history of myeloproliferative neoplasm
Additional locations may be listed on ClinicalTrials.gov for NCT04227847.
