KQB198-102 = KQB198 in Participants with Advanced Hematologic Malignancies [USA]

Study title

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

Scientific title

A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of KQB198 As Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Hematologic Malignancies

Type of study

Phase

Phase 1

Current status

Recruiting

Other trial ID

ClinicalTrials.gov NCT06645886

What is the purpose of the study

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

What will happen during the study

Study participants will:

  • take KQB198 daily, alone or in combination with dasatinib
  • visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that

Key inclusion criteria

This study includes patients of all sexes who:

  • are 18 years or older
  • have adequate organ function

Part 1 and Part 2, Cohort B – participants who:

  • have been diagnosed with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
  • have been previously treated with at least 2 different tyrosine kinase inhibitors (TKIs) and are relapsed from or intolerant to those TKIs
  • are ineligible for alternative therapeutic options likely to produce clinical benefit as determined by the investigator.

Part 2, Cohort A – participants who:

  • have 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

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • have CML in accelerated or blast phase
  • have received therapy with a similar mechanism of action to the study drug, KQB198
  • have a 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
  • have a history of interstitial lung disease
  • have abnormalities of the heart

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

August 2027

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by of the U. S. National Institutes of Health.

Study sponsor

Kumquat Biosciences Inc.

Scientific lead / contact

Kumquat Clinical Development

Principal investigator

Study centers / principal investigators

United States

Colorado

Colorado Blood Cancer Institute
Denver, Colorado, 80218

Michigan

Karmanos Cancer Institute
Detroit, Micigan, 48201

Ohio

Oncology Hematology Cincinnati
Cincinnati, Ohio, 45236

Tennessee

SCRI – Transplant and Cellular Therapy Operations
Nashville, Tennessee, 37203

Texas

Texas Oncology Austin Central
Austin, Texas, 78731

MD Anderson Cancer Center
Houston, Texas, 77030

Virginia

Virginia Cancer Specialists
Fairfax, Virginia, 22031