Investigating KQB198 for treating advanced blood cancers
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
This study is testing a new drug called KQB198 to see if it can safely help adults with advanced blood cancers, either on its own or with other cancer treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kumquat Biosciences Inc. Industry-sponsored |
| Drugs / interventions | dasatinib |
| Locations | 21 sites (San Francisco, California and 20 other locations) |
| Trial ID | NCT06645886 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of KQB198, both as a standalone treatment and in combination with other anti-cancer drugs, for adults with advanced hematologic malignancies. Participants will take KQB198 daily and will be monitored through regular clinic visits to assess the drug's effects on tumor size and its safety profile. The study will also investigate how KQB198 is processed in the body. The trial includes specific cohorts based on prior treatments and responses to existing therapies.
Who should consider this trial
Good fit: Ideal candidates include adults with Ph+ CML in chronic phase who have previously been treated with multiple TKIs and are not responding to those treatments.
Not a fit: Patients with CML in accelerated or blast phase or those who have had prior therapy with a similar mechanism to KQB198 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced hematologic malignancies who have limited alternatives.
How similar studies have performed: Other studies have shown promise with similar approaches, but the specific use of KQB198 is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 20 other locations
- University of California, San Francisco (UCSF) — San Francisco, California, United States (Recruiting)
- Colorado Blood Cancer Institute — Denver, Colorado, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- Oncology Hematology Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- Sarah Cannon Research Institute (SCRI) - Transplant and Cellular Therapy Operations — Nashville, Tennessee, United States (Recruiting)
- Texas Oncology Austin Central — Austin, Texas, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (Recruiting)
- CHRU de Tours - Hopital Bretonneau — Tours, Centre-Val de Loire, France (Recruiting)
- AP-HM - Hopital de la Timone — Marseille, France (Recruiting)
- Universitaetsklinikum Jena — Jena, Thuringia, Germany (Recruiting)
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore — Roma, Lazio, Italy (Recruiting)
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola — Bologna, Italy (Recruiting)
- Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii — Gdańsk, Pomeranian Voivodeship, Poland (Recruiting)
- Pratia Onkologia Katowice — Katowice, Silesian Voivodeship, Poland (Recruiting)
- Aidport Sp. z o.o. — Poznań, Wielkopolskie, Poland (Recruiting)
- Hospital Regional Universitario de Malaga — Málaga, Andalusia, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Community of Madrid, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Community of Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Kumquat Clinical Development
- Email: kumquatstudies@kumquatbio.com
- Phone: 858-214-2700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.