NCT06708897

A Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Select Low-grad Lymphomas

Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Select Low-grade Lymphomas

• Status: 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 chronic lymphocytic leukemia, small lymphocytic lymphoma, and select low-grad lymphomas.

Detailed description

A Phase 1, Open-label, Dose Escalation and Dose Expansion, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Select Low-grad Lymphomas. The study is an open-label, with 2 parts. Part 1 will utilize a 3+3 design. Eligible patients will be sequentially enrolled into each of 5 planned dose level cohorts. The purpose of Part 1 dose escalation is to determine the maximum tolerated dose of ZE50-0134. IPart 2 is a dose expansion of ZE50-0134 and will include two distinct doses who are venetoclax naïve treated at either the Biologically Effective Dose or Maximum Tolerated Dose and one dose lower. The purpose of Part 2 is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ZE50-0134 in subjects with CLL/SLL.

Conditions

• CLL / SLL
• CLL (Chronic Lymphocytic Leukemia)
• SLL (Small Lymphocytic Lymphoma)

Interventions

Type	Name	Description
DRUG	ZE 50-0134	oral capsules QD

Timeline

• Start date: 2025-04-08
• Primary completion: 2026-03-01
• Completion: 2028-04-01
• First posted: 2024-11-27
• Last updated: 2025-12-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study