KQB198-102 = KQB198 in Participants with Advanced Hematologic Malignancies [Europe, USA]

What is the purpose of the study

The goal of this study is to learn if KQB198 works to treat advanced hematologic malignancies in adults. It will also assess the safety of KQB198. The main questions it aims to answer are:

• What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs?
• Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor?
• What happens to KQB198 in the body?

What will happen during the study

Study participants will:

• take KQB198 daily, alone or in combination with dasatinib
• visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that

Key inclusion criteria

This study includes patients of all sexes who:

• are 18 years or older
• have adequate organ function

Part 1 and Part 2, Cohort B – participants who:

• have been diagnosed with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
• have been previously treated with at least 2 different tyrosine kinase inhibitors (TKIs) and are relapsed from or intolerant to those TKIs
• are ineligible for alternative therapeutic options likely to produce clinical benefit as determined by the investigator.

Part 2, Cohort A – participants who:

• have Ph+ CML in chronic phase who are on dasatinib prior to study entry and have a warning or failure to dasatinib as determined by the investigator per ELN 2020 guidelines

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

• have CML in accelerated or blast phase
• have received therapy with a similar mechanism of action to the study drug, KQB198
• have a history of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
• have a history of interstitial lung disease
• have abnormalities of the heart

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by of the U. S. National Institutes of Health.

Study centers / principal investigators

France

AP-HM – Hopital de la Timone
Marseille, France, 13005

CHRU de Tours – Hopital Bretonneau
Tours, Centre-Val de Loire, 37044

Germany

Medizinische Hochschule Hannover (MHH)
Hanover, 30625

Universitaetsklinikum Jena
Jena, 07747

Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna – Policlinico di Sant Orsola
Bologna, 40138

Fondazione Policlinico Universitario A. Gemelli IRCCS – Universita Cattolica del Sacro Cuore
Rome, 00168

ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162

Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano
Milan, Milan, 20122

Netherlands

Stichting Radboud Universitair Medisch Centrum
Nijmegen, 6525

Poland

Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
Gdansk, 80-214

Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, 80-952

Pratia Onkologia Katowice
Katowice, 40-519

Aidport Sp. z o.o.
Poznan, 60-185

Spain

Institut Catala d’Oncologia – L’Hospitalet
L’Hospitalet de Llobregat, Catalonia, Spain, 08908

Hospital Universitario 12 de Octubre
Madrid, 28041

Hospital Universitario La Paz
Madrid, 28046

Hospital Regional Universitario de Malaga
Málaga, 29010

United Kingdom

Hammersmith Hospital
London, W12 0HS

Nottingham University Hospitals
Nottingham, NG5 1PB

United States

California

University of California, San Francisco (UCSF)
San Francisco, California, 94143

Colorado

Colorado Blood Cancer Institute
Denver, Colorado, 80218

Florida

Moffitt Cancer Center
Tampa, Florida, 33612

Michigan

Karmanos Cancer Institute
Detroit, Micigan, 48201

North Carolina

Duke University Medical Center
Durham, North Carolina, 27710

Ohio

Oncology Hematology Cincinnati
Cincinnati, Ohio, 45236

Tennessee

SCRI – Transplant and Cellular Therapy Operations
Nashville, Tennessee, 37203

Texas

Texas Oncology Austin Central
Austin, Texas, 78731

MD Anderson Cancer Center
Houston, Texas, 77030

Virginia

Virginia Cancer Specialists
Fairfax, Virginia, 22031