This study is in progress, not accepting new patients

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

a study on Hematologic Malignancy Hematologic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

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

Official 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

Keywords

Hematologic Malignancies, Adult, CML, dasatinib, Hematologic Neoplasms, KQB198

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • University of California, San Francisco (UCSF)
    San Francisco California 94143 United States
  • Colorado Blood Cancer Institute
    Denver Colorado 80218 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kumquat Biosciences Inc.
ID
NCT06645886
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 13 people participating
Last Updated