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

Launched by KUMQUAT BIOSCIENCES INC. · Oct 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called KQB198 for adults with advanced blood cancers, known as hematologic malignancies. The main goals are to find out how safe KQB198 is, what the best dose is, and whether it can help shrink tumors either on its own or when combined with other cancer drugs. Participants in the trial will take KQB198 daily and will need to visit the clinic about eight times in the first two months, with less frequent visits afterward.

To be eligible for this trial, participants should have enough healthy organ function and specific types of chronic myeloid leukemia (CML) that have not responded well to previous treatments. Certain health conditions, like severe lung or heart issues, or prior treatments similar to KQB198, may prevent someone from joining. This trial is currently recruiting participants, and it's important for those interested to discuss their individual health conditions with their doctor to see if they qualify.

Gender

ALL

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