NCT07303660

A Phase 1b Study of Lonitoclax + Azacitidine in Acute Myeloid Leukemia Patients

A Phase 1b Study of Lonitoclax + Azacitidine (Aza) in Acute Myeloid Leukemia (AML) Patients

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Lomond Therapeutics Holdings, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory Acute Myeloid Leukemia patients.

Detailed description

It is an open-label Phase 1b clinical study of Lonitoclax + Aza in relapsed/refractory AML patients. The study is an open-label, with 2 parts. The phase 1b dose escalation portion would include relapsed/refractory patients, as well as in the expansion group. Once the phase 1b dose and schedule of Lonitoclax + Aza is defined in the 3 + 3 design with biologically effective dose assessment, an amendment will be filed with the Regulatory Authorities and expansion cohort of 30 relapsed and refractory AML patients would be enrolled at two different doses (15 patients per dose) to determine the RP2D; the first dosing will be at the presumed potential phase 2 dose combination and the second dosing will be below this.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	ZE50-0134	Oral capsules BID
DRUG	Azacitidine Days 1-7	75 mg/m2 daily, days 1-7
DRUG	ZE 50-0134	Oral capsules QD

Timeline

• Start date: 2026-01-10
• Primary completion: 2026-09-01
• Completion: 2027-11-01
• First posted: 2025-12-26
• Last updated: 2025-12-26

Regulatory

• FDA-regulated drug study