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Monoclonal Antibodies

KQB198 for Blood Cancers

Phase 1

Recruiting

Research Sponsored by Kumquat Biosciences Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 1 and Part 2, Cohort B Participants Only)

Be older than 18 years old

Must not have

CML in accelerated or blast phase

History of interstitial lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if KQB198 is effective in treating advanced blood cancers in adults and to determine its safety. It will investigate the proper dosage of KQB198 alone or combined with other cancer

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones may include nausea, fatigue, risk of infection due to immune system suppression, bleeding issues from low platelet counts, and potential liver toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My leukemia is in an advanced stage.

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I have a history of lung scarring or fibrosis.

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

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I have heart problems.

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I have a history of serious gut issues that could affect medication absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of study treatment and optimal biologic dose, as measured by molecular response (MR) per European Leukemia Network (ELN) 2020 Guidelines (Part 2).

Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)

Recommended Phase 2 Dose (RP2D) (Part 1)

Secondary study objectives

Efficacy of Study Treatment

Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 2)