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SGN-CD33A

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 9, 2018

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment116

FDA Designations

No designations recorded

Clinical trial landscape

SGN-CD33A · 1 trial · 2 indications

Phase 1 1
NCT02326584A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AMLAcute Myeloid Leukemia
COMPLETED116 Analytics
PHASE1COMPLETED
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
Through 1 month following last dose
Incidence of laboratory abnormalities
Through 1 month following last dose
Incidence of dose-limiting toxicity (DLT)
Through 1 month following last dose

Secondary Endpoints

Complete remission (CR) rate at the end of induction
Through 1 month following last dose
Leukemia-free survival
Up to approximately 3 years
Overall survival
Up to approximately 3 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Induction with SGN-CD33AEXPERIMENTAL7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A
Consolidation with SGN-CD33AEXPERIMENTALHigh dose cytarabine for consolidation + SGN-CD33A (28-day cycles)
SGN-CD33A MaintenanceEXPERIMENTALSGN-CD33A Monotherapy (42-day cycles)
Induction and Consolidation with SGN-CD33AEXPERIMENTAL7+3 (standard dose cytarabine for induction and daunorubicin) + SGN-CD33A and High dose cytarabine for consolidation + SGN-CD33A

Interventions

NameTypeDescription
Standard dose cytarabine for inductionDRUG100 mg/m2/day Days 1-7
SGN-CD33ADRUGGiven intravenously Day 1 or Days 1 and 4 of each cycle
DaunorubicinDRUG60 mg/m2/day Days 1-3
High dose cytarabine for consolidationDRUG3g/m2 on Days 1, 3, and 5 of each cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * All subtypes of Acute Myeloid leukemia (except for acute promyelocytic leukemia) * Eastern Cooperative Oncology Group status of 0 or 1 * Adequate baseline renal and hepatic function * Central venous access * Part specific requirements: eligible to receive induction; achieved C...

Countries:United States
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Frequently asked questions about SGN-CD33A

What is SGN-CD33A used for?

SGN-CD33A is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia (AML), also known as Acute Myelogenous Leukemia. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes SGN-CD33A?

SGN-CD33A is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Acute Myeloid Leukemia.

What phase is SGN-CD33A in?

SGN-CD33A is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its safety and potential efficacy in patients with Acute Myeloid Leukemia.

What clinical trials is SGN-CD33A in?

SGN-CD33A has been studied in one clinical trial, identified as NCT02326584, titled "A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML." This Phase 1 trial enrolled 116 participants in the United States and has been completed.

Is SGN-CD33A the same as vadastuximab talirine?

SGN-CD33A is also known as vadastuximab talirine. The drug is being developed by Pfizer for the treatment of Acute Myeloid Leukemia. It is an investigational agent that has been evaluated in a Phase 1 clinical trial.