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HMA

Phase 1

Acute Myelogenous Leukemia | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: Jan 5, 2018

HMA development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2013

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment195

FDA Designations

No designations recorded

HMA clinical trials

HMA · 1 trial · 3 indications

Phase 1 1
NCT01902329A Safety Study of SGN-CD33A in AML PatientsAcute Myelogenous Leukemia
COMPLETED195 Analytics
PHASE1COMPLETED
A Safety Study of SGN-CD33A in AML Patients
Acute Myelogenous 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

Secondary Endpoints

Blood concentrations of SGN-CD33A and metabolites
Through 3 weeks after dosing
Incidence of antitherapeutic antibodies
Through 1 month following last dose
Rate of complete remission
Up to 3 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SGN-CD33A + HMAEXPERIMENTALSGN-CD33A with hypomethylating agent
SGN-CD33A MonotherapyEXPERIMENTALSGN-CD33A

Interventions

NameTypeDescription
HMADRUGazacitidine 75 mg/m2 for 7 days or decitabine 20mg/m2 for 5 days
SGN-CD33ADRUGGiven intravenously on Day 1 or Days 1 and 4 every 3 weeks (SGN-CD33A Monotherapy) or given intravenously on the final HMA dosing day every 4 weeks (SGN-CD33A+HMA)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Acute myeloid leukemia, positive for CD33 * Eastern Cooperative Oncology Group status of 0 or 1 * Adequate baseline renal and hepatic function * Central venous access * Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation ...

Countries:United States
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Frequently asked questions about HMA

What is HMA?

HMA is an investigational small molecule developed by Pfizer, Inc. for acute myelogenous leukemia (AML), a cancer of the blood and bone marrow. It is in Phase 1 clinical development and has been studied in a completed safety trial. HMA is a biomarker-selected therapy, meaning treatment is directed at patients whose disease expresses a specific marker.

What is HMA used for in acute myelogenous leukemia?

HMA is being developed for the treatment of acute myelogenous leukemia, also called acute myeloid leukemia or AML. The clinical program has also included patients with acute promyelocytic leukemia. It is an investigational agent in Phase 1 development and is not an established treatment option for AML.

Who makes HMA?

HMA is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating HMA in acute myelogenous leukemia. The drug is a small molecule in Phase 1 development.

What phase is HMA in?

HMA is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 program in acute myelogenous leukemia has been completed, and no trials of HMA are currently listed as active.

What clinical trials is HMA in?

HMA has been evaluated in one completed Phase 1 trial, NCT01902329, titled A Safety Study of SGN-CD33A in AML Patients. The trial enrolled 195 participants aged 18 years and older in the United States and included patients with acute myelogenous leukemia, acute myeloid leukemia, and acute promyelocytic leukemia. It was a controlled study without randomization or double blinding.

Is HMA biomarker selected?

Yes. HMA is a biomarker-selected therapy, meaning its development targets patients whose disease carries a specific biological marker rather than an unselected AML population. This approach is intended to focus treatment on patients most likely to respond. HMA remains an investigational small molecule in Phase 1 development for acute myelogenous leukemia.