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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-09

Study Completion Date

2028-02-29

Brief Summary

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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

Detailed Description

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Conditions

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Hematologic Malignancies Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy Dose Escalation

Group Type EXPERIMENTAL

KQB198

Intervention Type DRUG

Oral KQB198

Combo Therapy Dose Escalation

Group Type EXPERIMENTAL

KQB198

Intervention Type DRUG

Oral KQB198

Dasatinib

Intervention Type DRUG

Oral dasatinib

Combo Therapy Dose Expansion - RP2D

Group Type EXPERIMENTAL

KQB198

Intervention Type DRUG

Oral KQB198

Dasatinib

Intervention Type DRUG

Oral dasatinib

Combo Therapy Dose Expansion - RP2D-1

Group Type EXPERIMENTAL

KQB198

Intervention Type DRUG

Oral KQB198

Dasatinib

Intervention Type DRUG

Oral dasatinib

Monotherapy Dose Expansion - RP2D

Group Type EXPERIMENTAL

KQB198

Intervention Type DRUG

Oral KQB198

Monotherapy Dose Expansion - RP2D -1

Group Type EXPERIMENTAL

KQB198

Intervention Type DRUG

Oral KQB198

Interventions

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KQB198

Oral KQB198

Intervention Type DRUG

Dasatinib

Oral dasatinib

Intervention Type DRUG

Eligibility Criteria

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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 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, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
* History of interstitial lung disease
* Cardiac abnormalities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kumquat Biosciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, San Francisco (UCSF)

San Francisco, California, United States

Site Status RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Oncology Hematology Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

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

Nashville, Tennessee, United States

Site Status RECRUITING

Texas Oncology Austin Central

Austin, Texas, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status RECRUITING

CHRU de Tours - Hopital Bretonneau

Tours, Centre-Val de Loire, France

Site Status RECRUITING

AP-HM - Hopital de la Timone

Marseille, , France

Site Status RECRUITING

Medizinische Hochschule Hannover (MHH)

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Universitaetsklinikum Jena

Jena, Thuringia, Germany

Site Status RECRUITING

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

Bologna, Bologna, Italy

Site Status RECRUITING

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

Rome, Lazio, Italy

Site Status RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, Italy

Site Status RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, Milan, Lombardy, Italy

Site Status RECRUITING

Stichting Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Aidport Sp. z o.o.

Poznan, Greater Poland Voivodeship, Poland

Site Status RECRUITING

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

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Pratia Onkologia Katowice

Katowice, Silesian Voivodeship, Poland

Site Status RECRUITING

Hospital Regional Universitario de Malaga

Málaga, Andalusia, Spain

Site Status RECRUITING

Institut Catala d'Oncologia - L'Hospitalet

L'Hospitalet de Llobregat, Catalonia, Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, Spain

Site Status RECRUITING

Hammersmith Hospital

London, Greater London, United Kingdom

Site Status RECRUITING

Nottingham University Hospitals

Nottingham, Nottinghamshire, United Kingdom

Site Status RECRUITING

Countries

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United States France Germany Italy Netherlands Poland Spain United Kingdom

Central Contacts

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Kumquat Clinical Development

Role: CONTACT

858-214-2700

Facility Contacts

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Jacklyn Sanchez Alvarez

Role: primary

Chris McKenney

Role: primary

Jordan Belliamy

Role: primary

Carmen Mitteer

Role: primary

313-576-9774

Erin Murphy

Role: primary

(919) 668-1608

Doug Hart

Role: primary

5137512273

Yesenia Romero Herazo

Role: primary

(615) 982-4331

Ashford Proctor

Role: primary

Cody Belgarde

Role: primary

Liliana Payne

Role: primary

Marie Allet

Role: primary

Julie Bianco

Role: primary

Gabriele Samson

Role: primary

+49 511 532-9321

Esther Machalett

Role: primary

Vanessa Bagnis

Role: primary

Rosaria Sola

Role: primary

Viola Chiavetta

Role: primary

+39 0264447597

Laura Willemse

Role: primary

Agnieszka Lesiak

Role: primary

+48 601246936

Malgorzata Rybczynska

Role: primary

+48797336387

Aleksadra Zaglewska

Role: primary

Agata Szkliniarz

Role: primary

+ 48 506 422 824

Sarai Garcia

Role: primary

Ariadna Lopez Coll

Role: primary

+34 932607068

Marina Melendez Mulio

Role: primary

(+34) 917792878

Raquel Gil

Role: primary

Other Identifiers

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KQB198-102

Identifier Type: -

Identifier Source: org_study_id

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