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

RECRUITINGPhase 1/2Sponsored by Kartos Therapeutics, Inc.
Actively Recruiting
PhasePhase 1/2
SponsorKartos Therapeutics, Inc.
Started2021-02-23
Est. completion2022-10
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites

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: 18 Years+Healthy volunteers accepted
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

Conditions4

CancerChronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaNon-hodgkin Lymphoma

Interventions2

Locations4 sites

Indiana

1 site
Goshen Center for Cancer Care
Goshen, Indiana, 46526

Ohio

2 sites
University of Cincinnati
Cincinnati, Ohio, 45221
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210

Texas

1 site
UT Southwestern Medical Center
Dallas, Texas, 75390

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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