KQB198 for Blood Cancers

Recruiting at 22 trial locations

Overseen By Kumquat Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kumquat Biosciences Inc.

Must be taking: Dasatinib

Disqualifiers: CML accelerated, Intestinal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 months

122 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, if you are in Part 2, Cohort A, you must be on dasatinib before joining the study.

Eligibility Criteria

This trial is for adults with advanced blood cancers. Participants will take KQB198 daily, alone or in combination with another anti-cancer drug, Dasatinib. They must visit the clinic frequently for monitoring.

Inclusion Criteria

My organs are working well.

I have chronic phase CML, have been treated with dasatinib, and it's not working well.

I have CML in chronic phase, tried at least 2 TKIs, and can't use other treatments.

Exclusion Criteria

My leukemia is in an advanced stage.

I have a history of lung scarring or fibrosis.

I have not been treated with drugs similar to KQB198 before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take KQB198 daily, alone or in combination with another anti-cancer drug

6 months

8 visits in the first 8 weeks, then once every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Long-term follow-up

Participants are monitored for long-term safety and efficacy outcomes

Up to 30 months

Treatment Details

Interventions

• KQB198

Trial Overview The study tests the safety and effectiveness of a new treatment, KQB198, both as a standalone therapy and combined with Dasatinib. It aims to find the safe dose and measure tumor response to these treatments.

Participant Groups

Group I: Monotherapy Dose Expansion - RP2D -1 Experimental Treatment 1 Intervention

Group II: Monotherapy Dose Expansion - RP2D Experimental Treatment 1 Intervention

Group III: Monotherapy Dose Escalation Experimental Treatment 1 Intervention

Group IV: Combo Therapy Dose Expansion - RP2D-1 Experimental Treatment 2 Interventions

Group V: Combo Therapy Dose Expansion - RP2D Experimental Treatment 2 Interventions

Group VI: Combo Therapy Dose Escalation Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Kumquat Biosciences Inc.

Lead Sponsor

Trials

3

Recruited

350+