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Uproleselan

Phase 1

Relapsed/Refractory AML | Small molecule | Oncology |Apollomics Inc.|Last Updated: Jun 27, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Uproleselan · 1 trial · 1 indication

Phase 1 1
NCT04839341Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML PatientsRelapsed/Refractory AML
COMPLETED12 Analytics
PHASE1COMPLETED
Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML Patients
Relapsed/Refractory AMLUnlock trial analytics

Study Endpoints

Primary Endpoints

Peak plasma concentration (Tmax)
14 days

To assess the pharmacokinetic profile in patients with relapsed/refractory AML.

Peak plasma concentration (Cmax)
14 days

To assess the pharmacokinetic profile in patients with relapsed/refractory AML.

Area under the plasma concentration-time curve from time zero to 12 hours (AUC0-12)
14 days

To assess the pharmacokinetic profile in patients with relapsed/refractory AML.

The area under the plasma concentration-time curve (AUC0-t) from time zero to the last measurable time point
14 days

To assess the pharmacokinetic profile in patients with relapsed/refractory AML.

The Incidence of Adverse Events
Up to 10 months

Number of participants with an AE.

The tolerance of participants with relapsed/refractory AML.
Up to 10 months

Number of participants could tolerate the Uproleselan combined with chemotherapy.

Secondary Endpoints

OS
Up to 3 years
Remission rate (rate of CR, CR/CRi and CR/CRh)
Up to 60 days
CTCAE grade 3 and 4 oral mucositis
Up to 254 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A Phase I, open-labeled multicenter studyEXPERIMENTALUproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC)

Interventions

NameTypeDescription
UproleselanDRUGA rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. ≥18 years and ≤60 years in age 2. AML (including secondary AML) diagnosed as per WHO standards (2008). 3. For refractory AML, only cytarabine/daunorubicin(or Idarubicin) as can be applied repeatedly(maximal twice) as induction, no other chemotherapy are allowed to be applied ...

Countries:China
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Frequently asked questions about Uproleselan

What is Uproleselan used for?

Uproleselan is an investigational small molecule being studied for the treatment of relapsed or refractory acute myeloid leukemia (AML). It is administered in combination with chemotherapy. As of now, it is in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing Uproleselan?

Uproleselan is being developed by Apollomics Inc., a biopharmaceutical company. Apollomics is publicly traded on the Nasdaq under the ticker symbol APLM. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of Uproleselan in patients with relapsed or refractory AML.

What phase is Uproleselan in?

Uproleselan is currently in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug's pharmacokinetics and safety when combined with chemotherapy in Chinese patients with relapsed or refractory AML. The drug remains investigational and is not yet approved for any use.

What clinical trials is Uproleselan in?

Uproleselan has one completed Phase 1 clinical trial registered under NCT04839341. This study evaluated the pharmacokinetics and safety of Uproleselan combined with chemotherapy in 12 Chinese patients with relapsed or refractory AML. The trial was uncontrolled and not blinded.

How does Uproleselan work?

Uproleselan is a small molecule designed to target E-selectin, a cell adhesion molecule that helps leukemia cells survive in the bone marrow. By blocking E-selectin, Uproleselan may make leukemia cells more vulnerable to chemotherapy. This mechanism is being investigated in the context of relapsed or refractory AML.