Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML Patients

• Status: Recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and tolerability of uproleselan(GMI-1271), a specific E-selectin antagonist, and characterize the pharmacokinetic (PK) profile of uproleselan, in combination with chemotherapy to treat Chinese relapsed/refractory AML patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apollomics Inc.
• Collaborator: Zhejiang CrownMab Biotech Co. Ltd

Criteria

Inclusion Key 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 Venatoclax /hypomethylation drug [HMA] can be used before and after chemotherapy.

1. For relapse AML, it must be the first or second relapse, and remain untreated.

2. Certain regimens (Venatoclax/HMA, Venetoclax/LDAC, HMA single agent) and FLT3 inhibitors, tyrosine kinase inhibitors, IDH1/IDH2 inhibitors or similar targeted inhibitors used alone are not considered cytotoxic chemotherapy are allowed.

4. ECOG performance status score is 0 to 2.

5. Stable hemodynamics and good organ function and good organ function.

Exclusion key Criteria:

1. Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML.

2. Active signs or symptoms of CNS involvement by malignancy.

3. Stem cell transplantation ≤4 months prior to dosing.

4. Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing.

5. Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.

6. Inadequate organ function.

7. Abnormal liver function.

8. Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.

9. Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).

10. Uncontrolled acute life-threatening bacterial, viral, or fungal infection.

11. Clinically significant cardiovascular disease.

12. Major surgery within 4 weeks of dosing.