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
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
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