An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma or Relapsed/Refractory Chronic Lymphocytic Leukemia

Kartos Therapeutics, Inc.

Summary

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)

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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

Interventions

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

Locations (45)

Goshen Center for Cancer Care
Goshen, Indiana
University of Cincinnati
Cincinnati, Ohio
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio
UT Southwestern Medical Center
Dallas, Texas
Royal Adelaide Hospital
Adelaide
Eastern Health - Box Hill Hospital
Box Hill