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SEA-CD70

Phase 1

Myelodysplastic Syndrome | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jul 22, 2026

Success Probability
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment178
FDA Designations
No designations recorded
Clinical trial landscape

SEA-CD70 · 1 trial · 2 indications

Phase 1 1
NCT04227847A Safety Study of SEA-CD70 in Patients With Myeloid MalignanciesMyelodysplastic Syndrome
RECRUITING178 Analytics
PHASE1RECRUITING
A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies
Myelodysplastic SyndromeUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs)
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
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)
Though end of DLT evaluation period; up to approximately 4 weeks

To be summarized using descriptive statistics.

Secondary Endpoints
AUC - Area under the plasma concentration-time curve
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Tmax - Time to maximum concentration attained
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Cmax - Maximum observed plasma concentration
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part AEXPERIMENTALSEA-CD70 dose escalation cohort in relapsed/refractory (HMA-failure) MDS
Part BEXPERIMENTALSEA-CD70 expansion cohort in relapsed/refractory (HMA-failure) MDS
Part CEXPERIMENTALSEA-CD70 expansion cohort in relapsed/refractory AML
Part DEXPERIMENTALSEA-CD70 + azacitidine dose-finding/dose optimization cohorts in relapsed/refractory MDS or MDS/AML, and previously untreated higher-risk MDS or MDS/AML
Part EEXPERIMENTALSEA-CD70 + azacitidine expansion cohort in previously untreated higher-risk MDS or MDS/AML
Part FEXPERIMENTALSEA-CD70 + azacitidine expansion cohort in relapsed/refractory MDS or MDS/AML
Part GEXPERIMENTALSEA-CD70 + azacitidine +venetoclax dose-finding/dose optimization in previously untreated and unfit for induction therapy AML
Interventions
NameTypeDescription
SEA-CD70DRUGGiven into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle
azacitidineDRUG75mg/m\^2 injected under the skin (SC; subcutaneous) or given into the vein (IV; intravenously) on Days 1 through 7 of each treatment cycle.
VenetoclaxDRUG400 mg /day PO, continuously; administered with ramping
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites53

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 * ...

Countries:United StatesJapanNetherlands
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Recent Changes (Last 90 Days)
LOWJul 22, 2026NCT04227847lastUpdatePostDate: changed
LOWJul 22, 2026NCT04227847lastUpdatePostDate: changed
LOWMay 26, 2026NCT04227847primaryCompletionDate: changed
LOWMay 24, 2026NCT04227847studyFirstPostDate: changed