A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies
NCT ID: NCT06645886
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
122 participants
INTERVENTIONAL
2024-12-09
2028-02-29
Brief Summary
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* 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?
Participants will:
* Take KQB198 daily, alone or in combination with another anti-cancer drug
* Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy Dose Escalation
KQB198
Oral KQB198
Combo Therapy Dose Escalation
KQB198
Oral KQB198
Dasatinib
Oral dasatinib
Combo Therapy Dose Expansion - RP2D
KQB198
Oral KQB198
Dasatinib
Oral dasatinib
Combo Therapy Dose Expansion - RP2D-1
KQB198
Oral KQB198
Dasatinib
Oral dasatinib
Monotherapy Dose Expansion - RP2D
KQB198
Oral KQB198
Monotherapy Dose Expansion - RP2D -1
KQB198
Oral KQB198
Interventions
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KQB198
Oral KQB198
Dasatinib
Oral dasatinib
Eligibility Criteria
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Inclusion Criteria
Part 1 and Part 2, Cohort B Participants Only:
• Ph+ CML in chronic phase who have been previously treated with at least 2 different tyrosine kinase inhibitors (TKIs) and are relapsed from or intolerant to those TKIs and ineligible for alternative therapeutic options likely to produce clinical benefit as determined by the investigator.
Part 2, Cohort A Participants Only:
• Participants with 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
Exclusion Criteria
* Prior therapy with a similar mechanism of action to KQB198
* 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
* History of interstitial lung disease
* Cardiac abnormalities
18 Years
ALL
No
Sponsors
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Kumquat Biosciences Inc.
INDUSTRY
Responsible Party
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Locations
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University of California, San Francisco (UCSF)
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Oncology Hematology Cincinnati
Cincinnati, Ohio, United States
Sarah Cannon Research Institute (SCRI) - Transplant and Cellular Therapy Operations
Nashville, Tennessee, United States
Texas Oncology Austin Central
Austin, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
CHRU de Tours - Hopital Bretonneau
Tours, Centre-Val de Loire, France
AP-HM - Hopital de la Timone
Marseille, , France
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Jena
Jena, Thuringia, Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
Bologna, Bologna, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, Lazio, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, Milan, Lombardy, Italy
Stichting Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, Netherlands
Aidport Sp. z o.o.
Poznan, Greater Poland Voivodeship, Poland
Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
Gdansk, Pomeranian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, Pomeranian Voivodeship, Poland
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, Poland
Hospital Regional Universitario de Malaga
Málaga, Andalusia, Spain
Institut Catala d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalonia, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hammersmith Hospital
London, Greater London, United Kingdom
Nottingham University Hospitals
Nottingham, Nottinghamshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KQB198-102
Identifier Type: -
Identifier Source: org_study_id
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