NCT04358393

A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS

A Phase Ib/II Study of APG-115 Alone or in Combination With Azacitidine in Patients With Relapse/Refractory AML, CMML or MDS

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two Part study in patients with relapsed/refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), or high risk myelodysplastic syndrome (MDS) that will initially evaluate the safety and tolerability of APG-115 as a single agent in Part 1, followed by a combination of APG-115 + 5-azacitidine (5-AZA) in Part 2.

Detailed description

Part 1: Dose escalation of APG-115 will use standard 3+3 design. APG-115 is administered orally once daily (QD) on Day 1-5 every 28-day cycle. The starting target dose is 100 mg (dose level; DL1) and will be increased in subsequent cohorts to 150 mg (DL2), 200 mg (DL3), and 250 mg (DL4), accordingly. Part 2: Dose escalation of APG-115 in combination with 5-AZA will use standard 3+3 design. 5-AZA is administered at 75 mg/m˄2/d subcutaneously daily on Day 1-7 every 28 days.

Conditions

• AML
• Acute Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• CMML
• Myelodysplastic Syndromes
• High-risk Myelodysplastic Syndrome
• MDS

Interventions

Type	Name	Description
DRUG	APG-115	APG-115 given once daily on day 1-5 of every 28 day cycle
DRUG	5-azacitidine	5-AZA is given at 75 mg/m˄2/d subcutaneously daily on Day 1-7 every 28 days

Timeline

• Start date: 2020-12-04
• Primary completion: 2024-12-30
• Completion: 2025-12-30
• First posted: 2020-04-24
• Last updated: 2024-02-01

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study