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

Last updated: May 5, 2025
Sponsor: Kumquat Biosciences Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Hematologic Neoplasms

Neoplasms

Treatment

KQB198

Dasatinib

Clinical Study ID

NCT06645886
KQB198-102
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • 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, orother gastrointestinal conditions likely to alter absorption of study treatment orresult in inability to swallow

  • History of interstitial lung disease

  • Cardiac abnormalities

Study Design

Total Participants: 122
Treatment Group(s): 2
Primary Treatment: KQB198
Phase: 1
Study Start date:
December 09, 2024
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • CHRU de Tours - Hopital Bretonneau

    Tours, Centre-Val de Loire 37044
    France

    Active - Recruiting

  • AP-HM - Hopital de la Timone

    Marseille, 13005
    France

    Active - Recruiting

  • Universitaetsklinikum Jena

    Jena, Thuringia 07747
    Germany

    Active - Recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Roma, Lazio 00168
    Italy

    Active - Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola

    Bologna, 40138
    Italy

    Active - Recruiting

  • Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii

    Gdańsk, Pomeranian Voivodeship 80-214
    Poland

    Active - Recruiting

  • Pratia Onkologia Katowice

    Katowice, Silesian Voivodeship 40-519
    Poland

    Active - Recruiting

  • Aidport Sp. z o.o.

    Poznań, Wielkopolskie 60-185
    Poland

    Active - Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, Andalusia 29010
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Community of Madrid 28041
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, Community of Madrid 28046
    Spain

    Active - Recruiting

  • University of California, San Francisco (UCSF)

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Oncology Hematology Cincinnati

    Cincinnati, Ohio 45236
    United States

    Active - Recruiting

  • SCRI - Transplant and Cellular Therapy Operations

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute (SCRI) - Transplant and Cellular Therapy Operations

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Texas Oncology Austin Central

    Austin, Texas 78731
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.