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

NCT04502394 · tracked via the Priya Life Science UK tracker

Sponsor

Kartos Therapeutics, Inc.

Phase

Phase 1/2

Started

2021-02-23

Last updated

2022-08-04

Condition(s) studied

Diffuse Large B Cell LymphomaChronic Lymphocytic LeukemiaNon Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

KRT-232acalabrutinib

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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 — 56 Days
Endpoint/Outcome Measures: Dose-limiting toxicities will be used to establish the MTD/MAD of KRT-232 in combination with acalabrutinib. The Safety Review Committee will determine the RP2D based on safety data of the combination of KRT-232 and acalabrutinib.
Primary Objective Phase 2: Cohort 1: To determine the complete response (CR) — 1 Year
Endpoint/Outcome Measures: Cohort 1: The proportion of subjects with CR as assessed by investigators per the Lugano Classification.
Primary Objective Phase 2: Cohort 2: To determine the rate of CR/complete remission with incomplete hematologic recovery (CRi) rate in R/R CLL — 1 Year
Endpoint/Outcome Measures: Cohort 2: The proportion of subjects with CR/CRi as assessed by investigators per iwCLL Response Criteria.

Trial sites (45)

Facility	City	Region	Status
Goshen Center for Cancer Care	Goshen	Indiana	Recruiting
University of Cincinnati	Cincinnati	Ohio	Recruiting
The Ohio State University Comprehensive Cancer Center	Columbus	Ohio	Recruiting
UT Southwestern Medical Center	Dallas	Texas	Recruiting
Royal Adelaide Hospital	Adelaide	Australia	Recruiting
Eastern Health - Box Hill Hospital	Box Hill	Australia	Recruiting
Barwon Health	Geelong	Australia	Recruiting
Royal Perth Hospital	Perth	Australia	Recruiting
Antwerp University Hospital (UZA)	Edegem	Belgium	Recruiting
Jessa Ziekenhuis	Hasselt	Belgium	Recruiting
University Hospital (UZ) Leuven	Leuven	Belgium	Recruiting
Fakultni Nemocnice Hradec Kralove	Nový Hradec Králové	Czechia	Recruiting
Fakultni nemocnice Ostrava	Ostrava	Czechia	Recruiting
Vseobecna fakultni nemocnice v Praze	Prague	Czechia	Recruiting
CHU de Nantes - Hôtel-Dieu	Nantes	France	Recruiting
Centre Henri Becquerel	Rouen	France	Recruiting
CHRU de Tours - Hôpital Bretonneau	Tours	France	Recruiting
Centro Riferimento Oncologico - Aviano	Aviano	Italy	Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	Meldola	Italy	Recruiting
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy	Recruiting
IRCCS Ospedale San Raffaele	Milan	Italy	Recruiting
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy	Recruiting
Centro Ricerche Cliniche di Verona s.r.l.	Verona	Italy	Recruiting
Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii	Gdansk	Poland	Recruiting
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii	Gdansk	Poland	Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii	Gliwice	Poland	Recruiting
Pratia MCM Krakow	Krakow	Poland	Recruiting
Szpital Uniwersytecki Krakow - Oddzial Kliniczny Hematologii	Krakow	Poland	Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu	Wroclaw	Poland	Recruiting
Hospital de Braga	Braga	Portugal	Recruiting
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria	Lisbon	Portugal	Recruiting
Champalimaud Cancer Center	Lisbon	Portugal	Recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE	Porto	Portugal	Recruiting
Centro Hospitalar de Vila Nova de Gaia/Espinho EPE	Vila Nova de Gaia	Portugal	Recruiting
National Cancer Center	Goyang	South Korea	Recruiting
Gachon University Gil Medical Center	Incheon	South Korea	Recruiting
Samsung Medical Center	Seoul	South Korea	Recruiting
Seoul National University Hospital	Seoul	South Korea	Recruiting
Seoul St. Mary's Hospital	Seoul	South Korea	Recruiting
Severance Hospital, Yonsei University Health System	Seoul	South Korea	Recruiting

+ 5 more sites — see the full list on the official registry below.

On this site

📄 Calquence (acalabrutinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04502394 on ClinicalTrials.gov ↗ ← All trials in the UK