Clinical Trials in Italy / NCT06645886
Active, not recruiting
Phase 1
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies
NCT06645886 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Hematologic MalignanciesAdult
Investigational drug(s) / intervention(s)
KQB198: Oral KQB198
Dasatinib: Oral dasatinib
Study 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
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 outcome measure(s)
- Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) — 28 Days
Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 28 days after last dose of study treatment. - Recommended Phase 2 Dose (RP2D) (Part 1) — Up to 30 months
Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D. - Efficacy of study treatment and optimal biologic dose, as measured by molecular response (MR) per European Leukemia Network (ELN) 2020 Guidelines (Part 2). — Up to 6 Months
Molecular response is the percentage of BCR-ABL fusion protein found in blood. Calculation of molecular response in Part 2 Cohort A will be the proportion of subjects that experience molecular response 4 (MR4) during the time period from 1st dose of study treatment until 6 months of study treatment. Calculation of molecular response in part 2 cohort B will be the proportion of subjects that experience molecular response 3 (MR3) during the time period from 1st dose of study treatment until 6 months of study treatment.
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California, San Francisco (UCSF) | San Francisco | California | |
| Colorado Blood Cancer Institute | Denver | Colorado | |
| Moffitt Cancer Center | Tampa | Florida | |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | |
| Duke University Medical Center | Durham | North Carolina | |
| Oncology Hematology Cincinnati | Cincinnati | Ohio | |
| Sarah Cannon Research Institute (SCRI) - Transplant and Cellular Therapy Operations | Nashville | Tennessee | |
| Texas Oncology Austin Central | Austin | Texas | |
| MD Anderson Cancer Center | Houston | Texas | |
| Virginia Cancer Specialists | Fairfax | Virginia | |
| CHRU de Tours - Hopital Bretonneau | Tours | Centre-Val de Loire | |
| AP-HM - Hopital de la Timone | Marseille | France | |
| Medizinische Hochschule Hannover (MHH) | Hanover | Lower Saxony | |
| Universitaetsklinikum Jena | Jena | Thuringia | |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola | Bologna | Bologna | |
| Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore | Rome | Lazio | |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Lombardy | |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano | Milan | Milan, Lombardy | |
| Stichting Radboud Universitair Medisch Centrum | Nijmegen | Gelderland | |
| Aidport Sp. z o.o. | Poznan | Greater Poland Voivodeship | |
| Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii | Gdansk | Pomeranian Voivodeship | |
| Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii | Gdansk | Pomeranian Voivodeship | |
| Pratia Onkologia Katowice | Katowice | Silesian Voivodeship | |
| Hospital Regional Universitario de Malaga | Málaga | Andalusia | |
| Institut Catala d'Oncologia - L'Hospitalet | L'Hospitalet de Llobregat | Catalonia | |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | |
| Hospital Universitario La Paz | Madrid | Madrid | |
| Hammersmith Hospital | London | Greater London | |
| Nottingham University Hospitals | Nottingham | Nottinghamshire |
On this site
📄 Sprycel (dasatinib) drug profile →More Kumquat Biosciences Inc. trials in Italy
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06645886 on ClinicalTrials.gov ↗ ← All trials in Italy