A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies

Running, not enrolling · Phase 1

Conditions studied: Hematologic Malignancies, Adult

In brief

The goal of this clinical trial is to learn if KQB198 works to treat advanced hematologic malignancies in adults. It will also learn about 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? 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

Key facts

Study ID

NCT06645886

Run by

Kumquat Biosciences Inc.

People needed

13

Starts

2024-12-09

Expected to finish

2027-03-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adequate organ function
• 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

You may not qualify if…

• CML in accelerated or blast phase
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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