Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Select Low-grade Lymphomas
Lomond Therapeutics Holdings, Inc.
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.
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-…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men and women aged ≥18 years. 2. Disease as defined below: Part 1: Patients with symptomatic CLL or SLL (defined by iwCLL) without del(17p)/TP53 must have received ≥2 prior therapies that have included a BTKi and venetoclax (or declined this) or Patients with progressive low-grade lymphoma that includes marginal zone lymphoma, lymphoplasmacytic lymphoma (including Waldenstrom's macroglobulinemia) who have received at least 2 therapies including a BTKi and CD20 antibody-based therapy. Part 2: Patients with symptomatic CLL or SLL (defined by iwCLL) must have recei…
Interventions
- DrugZE 50-0134
oral capsules QD
Locations (4)
- Norton Cancer Institute, St. Matthews CampusLouisville, Kentucky
- University of North Carolina at Chapel HillChapel Hill, North Carolina
- University of CincinnatiCincinnati, Ohio
- The Ohio State UniversityColumbus, Ohio