NCT04139434

Dose-Escalation Study of Oral Administration of LP-108 as Monotherapy and in Combination With Azacitidine in Patients With Relapsed or Refractory MDS, CMML, or AML

A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination With Azacitidine in Subjects With Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Newave Pharmaceutical Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination with Azacitidine in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

Detailed description

The primary objectives are to assess the safety and tolerability profile, determine the maximum tolerated dose (MTD), and/or the recommended Phase 2 dose (RP2D) of LP-108 administered daily as a single agent dosed orally and in combination with azacitidine at 75 mg/m2 in adult subjects with relapsed/refractory MDS/CMML/AML; to characterize the pharmacokinetics (PK) profile of LP-108 as monotherapy and in combination with azacitidine in adult subjects with relapsed/refractory MDS/CMML/AML. Secondary objectives are to evaluate preliminary efficacy regarding the effect of LP-108 (monotherapy or combination therapy) on ORR for AML, MDS, CMML, PFS, DOR, and OS

Conditions

• AML/MDS
• CMML
• Relapse
• Refractory Acute Lymphoblastic Leukemia
• Relapse Leukemia
• Relapsed Adult AML

Interventions

Type	Name	Description
DRUG	LP-108	For the dose escalation phase, LP-108 will be given once daily at the following dose levels: 100 mg QD, 200 mg QD, 400 mg QD, 600 mg QD, 800 mg QD, 1000 mg QD.
DRUG	LP-108 and azacitidine	For the dose escalation phase, LP-108 will be given once daily at the following dose levels: 100 mg QD, 200 mg QD, 400 mg QD, 600 mg QD, 800 mg QD, 1000 mg QD, with azacitidine at the standard dose of 75 mg/m2 on Day 1 - Day 7 of each 28-day cycle (weekly schedule) or on Days 1-5, 8, 9 of each 28-day cycle (5-2-2 schedule), according to institutional guidelines.

Timeline

• Start date: 2020-07-06
• Primary completion: 2025-12-19
• Completion: 2025-12-19
• First posted: 2019-10-25
• Last updated: 2026-01-23

Locations

7 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study