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
Who is this study for? Adult patients with Diffuse Large B Cell Lymphoma or Chronic Lymphocytic Leukemia
What treatments are being studied? KRT-232
Status: Recruiting
Location: See all (42) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Indiana
Goshen Center for Cancer Care
RECRUITING
Goshen
Ohio
University of Cincinnati
RECRUITING
Cincinnati
The Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Eastern Health - Box Hill Hospital
RECRUITING
Box Hill
Barwon Health
RECRUITING
Geelong
Royal Perth Hospital
RECRUITING
Perth
Belgium
Antwerp University Hospital (UZA)
RECRUITING
Edegem
Jessa Ziekenhuis
RECRUITING
Hasselt
University Hospital (UZ) Leuven
RECRUITING
Leuven
France
CHU de Nantes - Hôtel-Dieu
RECRUITING
Nantes
Centre Henri Becquerel
RECRUITING
Rouen
CHRU de Tours - Hôpital Bretonneau
RECRUITING
Tours
Italy
Centro Riferimento Oncologico - Aviano
RECRUITING
Aviano
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
RECRUITING
Meldola
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Centro Ricerche Cliniche di Verona s.r.l.
RECRUITING
Verona
Poland
Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
RECRUITING
Gdansk
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
RECRUITING
Gdansk
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii
RECRUITING
Gliwice
Pratia MCM Krakow
RECRUITING
Krakow
Szpital Uniwersytecki Krakow - Oddzial Kliniczny Hematologii
RECRUITING
Krakow
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
RECRUITING
Wroclaw
Portugal
Hospital de Braga
RECRUITING
Braga
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
RECRUITING
Lisbon
Champalimaud Cancer Center
RECRUITING
Lisbon
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
RECRUITING
Porto
Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
RECRUITING
Vila Nova De Gaia
Republic of Korea
National Cancer Center
RECRUITING
Goyang
Gachon University Gil Medical Center
RECRUITING
Incheon
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Seoul St. Mary's Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Switzerland
Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
United Kingdom
St James's University Hospital
RECRUITING
Leeds
King's College Hospital
RECRUITING
London
Royal Marsden Foundation Trust
RECRUITING
London
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Contact Information
Primary
John Mei
jmei@kartosthera.com
650-542-0136
Backup
Michael Yee
myee@kartosthera.com
650-839-7361
Time Frame
Start Date: 2021-02-23
Estimated Completion Date: 2024-03
Participants
Target number of participants: 84
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Kartos Therapeutics, Inc.