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

Kumquat Biosciences Inc.

Status and phase: Enrolling; Phase 1

Conditions: Adult; Hematologic Malignancies

Treatments: Drug: Dasatinib; Drug: KQB198

Study type: Interventional

Funder types: Industry

Identifiers

NCT06645886

KQB198-102

Details and patient eligibility

About

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

Enrollment: 122 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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122 participants in 6 patient groups

Monotherapy Dose Escalation

Experimental group

Treatment:

Drug: KQB198

Combo Therapy Dose Escalation

Experimental group

Treatment:

Drug: KQB198

Drug: Dasatinib

Combo Therapy Dose Expansion - RP2D

Experimental group

Treatment:

Drug: KQB198

Drug: Dasatinib

Combo Therapy Dose Expansion - RP2D-1

Experimental group

Treatment:

Drug: KQB198

Drug: Dasatinib

Monotherapy Dose Expansion - RP2D

Experimental group

Treatment:

Drug: KQB198

Monotherapy Dose Expansion - RP2D -1

Experimental group

Treatment:

Drug: KQB198