Hematologic MalignanciesPhase 1NCT06645886
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies
A Phase 1 study testing KQB198 and Dasatinib in people with Hematologic Malignancies and Adult, run by Kumquat Biosciences Inc. at 29 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies, Adult
- What is being tested?
- KQB198 and Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 29 sitesin 8 countries
- Study dates
- 9 Dec 2024to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
29 sites in 8 countries.
29 sites in 8 countries
United States10 sites
Texas Oncology Austin Central
Austin, Texas, 78731
Oncology Hematology Cincinnati
Cincinnati, Ohio, 45236
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke University Medical Center
Durham, North Carolina, 27710
Virginia Cancer Specialists
Fairfax, Virginia, 22031
MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute (SCRI) - Transplant and Cellular Therapy Operations
Nashville, Tennessee, 37203
University of California, San Francisco (UCSF)
San Francisco, California, 94143
Moffitt Cancer Center
Tampa, Florida, 33612
Italy4 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
Bologna, Bologna, 40138
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, Milan, Lombardy, 20122
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, Lazio, 00168
Poland4 sites
Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii
Gdansk, Pomeranian Voivodeship, 80-214
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, Pomeranian Voivodeship, 80-952
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, 40-519
Aidport Sp. z o.o.
Poznan, Greater Poland Voivodeship, 60-185
Spain4 sites
Institut Catala d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalonia, 08908
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29010
France2 sites
AP-HM - Hopital de la Timone
Marseille, 13005
CHRU de Tours - Hopital Bretonneau
Tours, Centre-Val de Loire, 37044
Germany2 sites
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, 30625
Universitaetsklinikum Jena
Jena, Thuringia, 07747
United Kingdom2 sites
Hammersmith Hospital
London, Greater London, W12 0HS
Nottingham University Hospitals
Nottingham, Nottinghamshire, NG5 1PB
Netherlands1 site
Stichting Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, 6525
About this study
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
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
- Conditions
- Hematologic Malignancies, Adult
- Being tested
- KQB198, Dasatinib
- Keywords
- CML, dasatinib
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KQB198Drug
Oral KQB198
DasatinibDrug
Oral dasatinib
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Not described Receives: Drug: KQB198 |
| Combo Therapy Dose Escalation | Experimental | Not described Receives: Drug: KQB198; Drug: Dasatinib |
| Combo Therapy Dose Expansion - RP2D | Experimental | Not described Receives: Drug: KQB198; Drug: Dasatinib |
| Combo Therapy Dose Expansion - RP2D-1 | Experimental | Not described Receives: Drug: KQB198; Drug: Dasatinib |
| Monotherapy Dose Expansion - RP2D | Experimental | Not described Receives: Drug: KQB198 |
| Monotherapy Dose Expansion - RP2D -1 | Experimental | Not described Receives: Drug: KQB198 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
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.
Measured: 28 Days
Recommended Phase 2 Dose (RP2D) (Part 1)
Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.
Measured: Up to 30 months
Efficacy of study treatment and optimal biologic dose, as measured by molecular response (MR) per European Leukemia Network (ELN) 2020 Guidelines (Part 2).
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.
Measured: Up to 6 Months
Secondary outcomes (7)
Efficacy of Study Treatment
Efficacy of study treatment as measured by molecular response (MR) at 3, 6, 9, and 12 months, and anytime.
Measured: Up to 30 months
Efficacy of Study Treatment
Efficacy of study treatment as measured by duration of response (DOR). DOR is defined as the time from the date when the response is first observed till the date the response is lost or death, whichever is earlier.
Measured: Up to 30 Months
Efficacy of Study Treatment
Efficacy of study treatment as measured by time to response (TTR). Response assessments will be summarized by all reported response categories at each visit.
Measured: Up to 30 months
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 2)
Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs from first dose of study treatment to 28 days after last dose of study treatment.
Measured: 28 Days After Last Dose
Concentration-Time Curve (AUC)
Measured: Up to 30 months
Maximum Plasma Concentration (Cmax)
Measured: Up to 30 months
Time to Maximum Plasma Concentration (tmax)
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start9 Dec 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumquat Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645886
- Sponsor's protocol ID
- KQB198-102
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06645886
- Acronym / sponsor ID
- KQB198-102
- Conditions
- Hematologic Malignancies, Adult
- Keywords
- CML, dasatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Kumquat Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation | Experimental | Drug: KQB198 |
| Combo Therapy Dose Escalation | Experimental | Drug: KQB198, Drug: Dasatinib |
| Combo Therapy Dose Expansion - RP2D | Experimental | Drug: KQB198, Drug: Dasatinib |
| Combo Therapy Dose Expansion - RP2D-1 | Experimental | Drug: KQB198, Drug: Dasatinib |
| Monotherapy Dose Expansion - RP2D | Experimental | Drug: KQB198 |
| Monotherapy Dose Expansion - RP2D -1 | Experimental | Drug: KQB198 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adequate organ function
- 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.
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KQB198Oral KQB198 | Drug | Combo Therapy Dose Escalation, Combo Therapy Dose Expansion - RP2D, Combo Therapy Dose Expansion - RP2D-1, Monotherapy Dose Escalation, Monotherapy Dose Expansion - RP2D, Monotherapy Dose Expansion - RP2D -1 |
| DasatinibOral dasatinib | Drug | Combo Therapy Dose Escalation, Combo Therapy Dose Expansion - RP2D, Combo Therapy Dose Expansion - RP2D-1 |
Primary outcome
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
Time frame: 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)
Time frame: 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).
Time frame: 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.
7 secondary outcomes
Efficacy of Study Treatment
Time frame: Up to 30 months
Efficacy of Study Treatment
Time frame: Up to 30 Months
Efficacy of Study Treatment
Time frame: Up to 30 months
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 2)
Time frame: 28 Days After Last Dose
Concentration-Time Curve (AUC)
Time frame: Up to 30 months
Maximum Plasma Concentration (Cmax)
Time frame: Up to 30 months
Time to Maximum Plasma Concentration (tmax)
Time frame: Up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KQB198 and Dasatinib in people with Hematologic Malignancies and Adult, run by Kumquat Biosciences Inc. at 29 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Italy, Poland, Spain, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) (time frame: 28 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.