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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Lomond Therapeutics Holdings, Inc.
Study ID
NCT06708897
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ZE 50-0134 — DRUG
    oral capsules QD

Study Details

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.

Key Dates

First listed
Nov 27, 2024
Start date
Apr 8, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2026
Completion
Apr 30, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Incidence of AEs and SAEs [ Time Frame: Up to 24 cycles, 4 weeks each ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Norton Cancer Institute, St. Matthews CampusLouisvilleKentucky40207-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
University of CincinnatiCincinnatiOhio45221-
The Ohio State UniversityColumbusOhio43210-

Find similar trials in Louisville, KY

By research site
Norton Cancer Institute, St. Matthews Campus· Louisville, KYUniversity of North Carolina at Chapel Hill· Chapel Hill, NCUniversity of Cincinnati· Cincinnati, OHThe Ohio State University· Columbus, OH

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