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

Part of paid clinical trials in Goshen, Indiana.

Sponsor
Kartos Therapeutics, Inc.
Study ID
NCT04502394
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • KRT-232 — DRUG
    KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth
  • acalabrutinib — DRUG
    acalabrutinib is a BTK inhibitor anticancer drug taken by mouth

Study Details

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)

Key Dates

First listed
Aug 6, 2020
Start date
Feb 23, 2021
Status verified
Aug 2022
Primary completion
Oct 31, 2022
Completion
Mar 31, 2024

Study Design

Enrollment
84 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Goshen Center for Cancer CareGoshenIndiana46526-
University of CincinnatiCincinnatiOhio45221-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
UT Southwestern Medical CenterDallasTexas75390-

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Goshen Center for Cancer Care· Goshen, INUniversity of Cincinnati· Cincinnati, OHThe Ohio State University Comprehensive Cancer Center· Columbus, OHUT Southwestern Medical Center· Dallas, TX

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