KQB198-102
Research type
Research Study
Full 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.
IRAS ID
1011042
Contact name
Mitra Shokri
Contact email
Sponsor organisation
Kumquat Biosciences
Eudract number
2024-511457-22
Clinicaltrials.gov Identifier
Research summary
In chronic myeloid leukaemia (CML), there are mutations that can cause resistance to standard treatments, such as tyrosine kinase inhibitors (e.g., imatinib, dasatinib). There is a protein that binds with BCR-ABL which allows CML stem cells to grow and survive which prevents remission of the disease. New medications are needed to treat CML after other available treatment options have stopped working. These medications may work alone or together with other approved treatments.
KQB198 is a drug that blocks a process in the CML cells that allows them to grow and survive. The goal of this study is to find a safe dose of KQB198 alone and in combination with dasatinib and to find out if it can impact cancer growth in humans. Dasatinib is a drug used for the treatment of CML.
Part 1 is a dose escalation in which patients with chronic phase CML will receive one of 4 doses of KQB198 either alone or with dasatinib to find the lowest dose of KQB198 that is safe and effective in patients. Both the patient and their doctor will know what treatment and dose they are receiving. Part 2 is an expansion of two doses of KQB198 that were found to be safe in Part 1 either alone or with dasatinib in patients with chronic phase CML, to compare whether the safety and efficacy is different between the doses. To participate in this study, patients must be at least 18 years old and have chronic phase CML that has been previously treated. All recruitment will occur at approved NHS sites. Patients can participate in the study until their cancer is no longer controlled. The duration of participation will vary by patient based upon the safety and efficacy of the therapy.REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0111
Date of REC Opinion
1 May 2025
REC opinion
Further Information Favourable Opinion