Recruiting
Phase 1
Phase 2

KRT-232 & Acalabrutinib

Sponsor:

Kartos Therapeutics, Inc.

Code:

NCT04502394

Conditions

Diffuse Large B Cell Lymphoma

Chronic Lymphocytic Leukemia

Non Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KRT-232

acalabrutinib

Study Details

Brief 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)

Conditions

Diffuse Large B Cell Lymphoma

Chronic Lymphocytic Leukemia

Non Hodgkin Lymphoma

Study ID

NCT04502394

Start date

Feb 23, 2021

Status verified date

Aug, 2022

Completion date

Mar, 2024

Anticipated

Primary completion date

Oct, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

KRT-232

KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth

acalabrutinib

acalabrutinib is a BTK inhibitor anticancer drug taken by mouth

Primary outcome measure

  • Primary Objective Phase 1b:To determine the KRT-232 maximum tolerated dose/ maximum administered dose (MTD/MAD) and recommended Phase 2 Dose (RP2D) in combination with acalabrutinib in subjects with R/R DLBCL or R/R CLL [ Time Frame: 56 Days ]
  • Primary Objective Phase 2: Cohort 1: To determine the complete response (CR) [ Time Frame: 1 Year ]
  • Primary Objective Phase 2: Cohort 2: To determine the rate of CR/complete remission with incomplete hematologic recovery (CRi) rate in R/R CLL [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

John Mei

650-542-0136jmei@kartosthera.com

Michael Yee

650-839-7361myee@kartosthera.com

Locations

Goshen Center for Cancer Care

Recruiting

Goshen, Indiana, United States, 46526

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45221

The Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

Kartos Therapeutics, Inc.

Last update posted

Aug 4, 2022

Last verified

Aug, 2022

Keywords

  • navtemadlin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kartos Therapeutics, Inc. on 2022-08-04.