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

NCT06645886 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: KQB198-102
• Study Type: interventional
• Target: 13
• Locations: 8 countries
• Sites: 29

Brief 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

Conditions

Hematologic Malignancies; Adult

Keywords

CML; dasatinib

Outcome Measures

Primary Outcomes (3)

• Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)

  Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 28 days after last dose of study treatment.

  28 Days

• Recommended Phase 2 Dose (RP2D) (Part 1)

  Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.

  Up to 30 months

• Efficacy of study treatment and optimal biologic dose, as measured by molecular response (MR) per European Leukemia Network (ELN) 2020 Guidelines (Part 2).

  Molecular response is the percentage of BCR-ABL fusion protein found in blood. Calculation of molecular response in Part 2 Cohort A will be the proportion of subjects that experience molecular response 4 (MR4) during the time period from 1st dose of study treatment until 6 months of study treatment. Calculation of molecular response in part 2 cohort B will be the proportion of subjects that experience molecular response 3 (MR3) during the time period from 1st dose of study treatment until 6 months of study treatment.

  Up to 6 Months

Secondary Outcomes (7)

• Efficacy of Study Treatment

  Up to 30 months

• Efficacy of Study Treatment

  Up to 30 Months

• Efficacy of Study Treatment

  Up to 30 months

• Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 2)

  28 Days After Last Dose

• Concentration-Time Curve (AUC)

  Up to 30 months

Study Arms (6)

Monotherapy Dose Escalation

EXPERIMENTAL

Drug: KQB198

Combo Therapy Dose Escalation

EXPERIMENTAL

Drug: KQB198; Drug: Dasatinib

Combo Therapy Dose Expansion - RP2D

EXPERIMENTAL

Drug: KQB198; Drug: Dasatinib

Combo Therapy Dose Expansion - RP2D-1

EXPERIMENTAL

Drug: KQB198; Drug: Dasatinib

Monotherapy Dose Expansion - RP2D

EXPERIMENTAL

Drug: KQB198

Monotherapy Dose Expansion - RP2D -1

EXPERIMENTAL

Drug: KQB198

Interventions

KQB198 DRUG

Oral KQB198

Combo Therapy Dose Escalation; Combo Therapy Dose Expansion - RP2D; Combo Therapy Dose Expansion - RP2D-1; Monotherapy Dose Escalation; Monotherapy Dose Expansion - RP2D; Monotherapy Dose Expansion - RP2D -1

Dasatinib DRUG

Oral dasatinib

Combo Therapy Dose Escalation; Combo Therapy Dose Expansion - RP2D; Combo Therapy Dose Expansion - RP2D-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Kumquat Biosciences Inc.: lead

Study Sites (29)

University of California, San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oncology Hematology Cincinnati

Cincinnati, Ohio, 45236, United States

Location

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

Nashville, Tennessee, 37203, United States

Location

Texas Oncology Austin Central

Austin, Texas, 78731, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

CHRU de Tours - Hopital Bretonneau

Tours, Centre-Val de Loire, 37044, France

Location

AP-HM - Hopital de la Timone

Marseille, 13005, France

Location

Medizinische Hochschule Hannover (MHH)

Hanover, Lower Saxony, 30625, Germany

Location

Universitaetsklinikum Jena

Jena, Thuringia, 07747, Germany

Location

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

Bologna, Bologna, 40138, Italy

Location

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

Rome, Lazio, 00168, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, 20162, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, Milan, Lombardy, 20122, Italy

Location

Stichting Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, 6525, Netherlands

Location

Aidport Sp. z o.o.

Poznan, Greater Poland Voivodeship, 60-185, Poland

Location

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

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

Gdansk, Pomeranian Voivodeship, 80-952, Poland

Location

Pratia Onkologia Katowice

Katowice, Silesian Voivodeship, 40-519, Poland

Location

Hospital Regional Universitario de Malaga

Málaga, Andalusia, 29010, Spain

Location

Institut Catala d'Oncologia - L'Hospitalet

L'Hospitalet de Llobregat, Catalonia, 08908, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hammersmith Hospital

London, Greater London, W12 0HS, United Kingdom

Location

Nottingham University Hospitals

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 17, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

NL (1); DE (2); PL (4); ES (4); US (10); FR (2); GB (2); IT (4)