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Trial Title:
A Study to Investigate the Safety and Efficacy of KQB198 As Monotherapy and in Combination in Participants with Advanced Hematologic Malignancies
NCT ID:
NCT06645886
Condition:
Hematologic Malignancies
Adult
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Dasatinib
Conditions: Keywords:
CML
dasatinib
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KQB198
Description:
Oral KQB198
Arm group label:
Combo Therapy Dose Escalation
Arm group label:
Combo Therapy Dose Expansion - RP2D
Arm group label:
Combo Therapy Dose Expansion - RP2D-1
Arm group label:
Monotherapy Dose Escalation
Arm group label:
Monotherapy Dose Expansion - RP2D
Arm group label:
Monotherapy Dose Expansion - RP2D -1
Intervention type:
Drug
Intervention name:
Dasatinib
Description:
Oral dasatinib
Arm group label:
Combo Therapy Dose Escalation
Arm group label:
Combo Therapy Dose Expansion - RP2D
Arm group label:
Combo Therapy Dose Expansion - RP2D-1
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI - Transplant and Cellular Therapy Operations
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Start date:
October 2024
Completion date:
February 2028
Lead sponsor:
Agency:
Kumquat Biosciences Inc.
Agency class:
Industry
Source:
Kumquat Biosciences Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06645886
