Clinical trial NCT06645886: A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hematologic Malignancies
Adult
Keywords: CML
dasatinib
Lead sponsor: Kumquat Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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


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

Primary outcomes:
measure: Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
timeFrame: 28 Days
measure: Recommended Phase 2 Dose (RP2D) (Part 1)
timeFrame: Up to 30 months
measure: Efficacy of study treatment and optimal biologic dose, as measured by molecular response (MR) per European Leukemia Network (ELN) 2020 Guidelines (Part 2).
timeFrame: Up to 6 Months
Secondary outcomes:
measure: Efficacy of Study Treatment
timeFrame: Up to 30 months
measure: Efficacy of Study Treatment
timeFrame: Up to 30 Months
measure: Efficacy of Study Treatment
timeFrame: Up to 30 months
measure: Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 2)
timeFrame: 28 Days After Last Dose
measure: Concentration-Time Curve (AUC)
timeFrame: Up to 30 months
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Up to 30 months
measure: Time to Maximum Plasma Concentration (tmax)
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Cincinnati
state: Ohio
city: Nashville
country: United States
facility: Sarah Cannon Research Institute (SCRI) - Transplant and Cellular Therapy Operations
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology Austin Central
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Tours
country: France
facility: CHRU de Tours - Hopital Bretonneau
state: Centre-Val de Loire
city: Marseille
country: France
facility: AP-HM - Hopital de la Timone
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
state: Thuringia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
state: Lazio
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
city: Gdańsk
country: Poland
facility: Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
state: Pomeranian Voivodeship
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
state: Silesian Voivodeship
city: Poznań
country: Poland
facility: Aidport Sp. z o.o.
state: Wielkopolskie
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
state: Andalusia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Community of Madrid
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
state: Community of Madrid
Study officials:
References: