*Myelodysplastic Syndrome *Acute Myeloid Leukemia
Conditions
Interventions
*Drug: SEA-CD70
-Given into the vein (IV
intravenously) on Days 1 and 15 of each treatment cycle
*Drug: 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.
-Other Names:
#VIDAZA
*Drug: Venetoclax
-400 mg /day PO, continuously
administered with ramping
-Other Names:
#Venclexta
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
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 =18 years. *ECOG Performance Status of 0-2.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Number of participants with adverse events (AEs) [Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years] -Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. *Number of participants with laboratory abnormalities [Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years] -To be summarized using descriptive statistics. *Number of participants with a dose-limiting toxicity (DLT) at each dose level (Parts A and D only) [Time Frame: Though end of DLT evaluation period; up to approximately 4 weeks] -To be summarized using descriptive statistics. | — |
Secondary
| Measure | Time frame |
|---|---|
| *AUC - Area under the plasma concentration-time curve [Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years] -To be summarized using descriptive statistics. *Tmax - Time to maximum concentration attained [Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years] -To be summarized using descriptive statistics. *Cmax - Maximum observed plasma concentration [Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years] -To be summarized using descriptive statistics. *Ctrough - Minimum plasma concentration per dosing interval [Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years] -To be summarized using descriptive statistics. *T1/2 - Terminal elimination half-life [Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years] -To be summarized using descriptive statistics. *Incidence of antidrug antibodies (ADA) [Time Frame: Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years] -To be summarized using descriptive statistics. *Complete remission (CR) Rate and complete remission equivalent (CReq) rate [Time Frame: Up to approximately 4 years] -Proportion of participants with AML, MDS/AML or MDS who achieve CR or CReq *Complete remission with incomplete blood count recovery (CRi) rate [Time Frame: Up to approximately 4 years] -Proportion of participants with AML who achieve CRi *Complete remission with limited count recovery (CRL) rate for participants with MDS or MDS/AML [Time Frame: Up to approximately 4 years] -Proportion of participants with MDS or MDS/AML who achieve CRL *Complete remission with partial hematologic recovery (CRh) rate [Time Frame: Up to approximately 4 years] -Proportion of participants with AML, MDS/AML, or MDS who achieve CRh *Hematologic response (HI) rate [Time Frame: Up to approximately 4 years] -Proportion of participants with MDS or MDS/AML with | — |
Countries
Japan, Netherlands, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed