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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

Frequently asked questions about SEA-CD70

What is SEA-CD40 used for?

SEA-CD40 is an investigational oncology drug being studied for the treatment of melanoma and myelodysplastic syndrome. It is in Phase 2 clinical development and is being developed by Pfizer, Inc. (NYSE: PFE).

What does SEA-CD40 target?

SEA-CD40 is a small molecule that targets CD40, a protein involved in immune system regulation. By modulating this target, it aims to enhance the body's immune response against cancer cells. The drug is being evaluated in combination with other drugs in certain cancers.

Who makes SEA-CD40?

SEA-CD40 is being developed by Pfizer, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical trials for oncology indications.

What phase is SEA-CD40 in?

SEA-CD40 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy in patients with certain types of cancer.

What clinical trials is SEA-CD40 in?

SEA-CD40 is being studied in two clinical trials. One is NCT04993677, a Phase 2 study of SEA-CD40 given with other drugs in cancers including melanoma and non-small-cell lung carcinoma. Another is NCT04227847, a Phase 1 study of SEA-CD70 in myeloid malignancies, which is also listed under the drug's alternative name.

Is SEA-CD40 the same as SEA-CD70?

Yes, SEA-CD40 is also known as SEA-CD70. The drug has been referred to by both names in clinical trial registrations. For example, the Phase 1 trial NCT04227847 is titled 'A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies' and is associated with this drug.