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
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Men and women aged ≥18 years.

⁃ 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 received ≥1 prior therapies that have included a BTKi and be venetoclax naive.

⁃ Prior to beginning part 2, an activation amendment will be submitted to the FDA that includes safety, pharmacokinetics, pharmacodynamics and early efficacy data from the Part 1 portion. At this time, we may also include cohorts of specific types of low-grade lymphoma as well. Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 7 days before the first dose of study drug:

∙ Absolute neutrophil count (ANC) \> 0.75 x 109/L. For subjects with documented bone marrow involvement ≥ 0.5 x 109/L

‣ Platelet count \> 50 x 109/L. For subjects with documented bone marrow involvement ≥ 30 x 109/L

‣ Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 3.0 x upper limit of normal (ULN)

‣ Total bilirubin ≤ 1.5 x ULN

‣ Creatinine or Cystatin C glomerular filtration rate (GFR) ≥60 mL/min. Estimated GFR (eGFR) according to the Modification of Diet in Renal Disease Study Group (MDRD) formula and expressed in mL/min. To convert mL/min/1.73 m2 to mL/min multiply by the individual's BSA calculated using an appropriate formula and divide by 1.73 Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less Negative serum or urine pregnancy test must be obtained within 7 days before the first dose of study drug in women of childbearing potential. Negative results must also be available before each cycle.

• Postmenopausal women, as defined below, are exempt from pregnancy testing:

• Age \>50 years with amenorrhea for at least 12 months or

• Age ≤50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (\>40 mIU/mL) OR

• Permanently sterilized women (e.g., hysterectomy, bilateral salpingectomy, or uterine ablation) Women and men of reproductive potential must agree to use highly effective contraception when sexually active. This applies for the period between signing of the informed consent and 90 days after the last administration of study drug. These methods should be documented in source documents. The investigator or a designated associate is requested to advise the subject on how to achieve highly effective birth control. Ability to understand and the willingness to sign a written informed consent. A signed informed consent (including consent for genetic biomarker

Locations
United States
Kentucky
Norton Cancer Institute, St. Matthews Campus
RECRUITING
Louisville
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Ohio
University of Cincinnati
RECRUITING
Cincinnati
The Ohio State University
RECRUITING
Columbus
Contact Information
Primary
Ekaterina Dokukina, PhD MD
kdokukina@eileanther.com
+38269728309
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2028-04
Participants
Target number of participants: 66
Treatments
Experimental: ZE50-0134 Dose Level -1
Optional and would only be performed Dose Level 1 is poorly tolerated
Experimental: ZE50-0134 Dose Level 1
Experimental: ZE50-0134 Dose Level 2
Experimental: ZE50-0134 Dose Level 3
Experimental: ZE50-0134 Dose Level 4
Experimental: ZE50-0134 Dose Level 5
Experimental: ZE50-0134 Selected dose 1
The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study
Experimental: ZE50-0134 Selected dose 2
The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study
Sponsors
Leads: Eilean Therapeutics

This content was sourced from clinicaltrials.gov