Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL

Purpose

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy)

Conditions

  • Diffuse Large B Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Non Hodgkin Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Cohort 1: Confirmed diagnosis of TP53wt DLBCL (WHO); R/R DLBCL after at least 2 prior lines of treatment or 1 prior for patients who are ineligible for stem cell transplant - Cohort 2: Confirmed diagnosis of TP53wt CLL (iwCLL); R/R CLL after at least 1 prior line of treatment - ECOG 0 to 2 - Adequate hematologic, hepatic, and renal functions.

Exclusion Criteria

  • Prior treatment with any MDM2 inhibitor - Prior treatment with any BTK inhibitor

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
An Open-label, Phase 1b/2 Study of KRT-232 in combination with acalabrutinib in Subjects with B-cell Non-Hodgkin Lymphoma
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 (R/R DLBCL) 		KRT-232 will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle. Acalabrutinib at 100 mg twice a day (BID) continuously starting on Day 1 in a 28-day cycle.
  • Drug: KRT-232
    KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth
  • Drug: acalabrutinib
    acalabrutinib is a BTK inhibitor anticancer drug taken by mouth
    Other names:
    • ACP-196
Experimental
Cohort 2 (R/R CLL) 		KRT-232 will be administered orally, once daily (QD), on days 1-7 in a 28-day cycle. Acalabrutinib at 100 mg twice a day (BID) continuously starting on Day 1 in a 28-day cycle.
  • Drug: KRT-232
    KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth
  • Drug: acalabrutinib
    acalabrutinib is a BTK inhibitor anticancer drug taken by mouth
    Other names:
    • ACP-196

Recruiting Locations

Goshen Center for Cancer Care
Goshen, Indiana 46526

University of Cincinnati
Cincinnati, Ohio 45221

The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210

UT Southwestern Medical Center
Dallas, Texas 75390

More Details

Status
Recruiting
Sponsor
Kartos Therapeutics, Inc.

Study Contact

John Mei
650-542-0136
jmei@kartosthera.com