Gastro Intestinal Stromal Tumour, Gastrointestinal Tumors, GIST, GIST - Gastrointestinal Stromal Tumor, GIST Metastatic Cancer
Conditions
Keywords
KQB198, imatinib, gleevec, gist, gastrointestinal stromal tumor, gastro intestinal stromal tumor, gist first line, gist 1st line, KQB198-103, SynerGIST, SynerGIST-1, SynerGIST-1st, SynerGIST-1st Line
Brief summary
This study will test an experimental drug called KQB198 in combination with imatinib. The goal is to determine if this combination is safe and tolerable and assess how effective the combination is at treating GIST. Imatinib has been approved by the FDA for the treatment of different types of cancer including GIST.
Interventions
DRUGKQB198
Oral KQB198
Oral Imatinib
Sponsors
Kumquat Biosciences Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All Participants: * Unresectable or metastatic disease * Tissue confirmation of GIST * Valid results from local testing of blood or tumor tissue documenting the presence of a KIT mutation (must not have exon 9 mutation) or PDGFRA mutation (must not have PDGFRA D842V). * Measurable disease per RECIST v1.1. * Patients must be in 1st line of treatment for advanced or metastatic disease. Prior imatinib is allowed in adjuvant or neoadjuvant setting, as long as imatinib was stopped over 1 year ago. * Adequate organ function and performance status
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: * Unable to swallow or GI condition that prevents absorption. * Other active malignancies within the last 2 years. * History of hypersensitivity to any component of KQB198 or imatinib.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 30 months | Evaluate efficacy of study treatment, as measured by Objective Response Rate (ORR) using Response Evaluation Criteria in Gastrointestinal Stromal Tumors (GIST). Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | 30 months | Duration of response defined as the time from date of the first documentation of objective tumor response (CR or PR) based on RECIST v1.1 to the first documentation of either PD or death due to any cause, whichever occurs first. |
| Disease control rate (DCR) | 30 months | Disease control rate is the proportion of subjects that experience confirmed complete response (CR), partial response (PR), or stable disease based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose. |
| Time to response (TTR) | 30 months | Time to response is defined as time from 1st dose of study treatment to date of 1st documentation of objective tumor response (CR or PR) based on RECIST v1.1. |
| Progression-free survival (PFS) | Up to 30 months | Progression-free survival is defined as the time from enrollment to the date of Progressive Disease (PD) based on RECIST v1.1 or death due to any cause, whichever occurs first. PFS at 6 months will also be characterized which indicates the proportion of subjects that experience progression within 6 months from time of enrollment. |
| Overall survival (OS) | Up to 30 months | Evaluate efficacy of study treatment characterized by OS. Overall survival is defined as the time from start of treatment to death. |
| Number of patients who experience treatment-emergent adverse advents, serious adverse events, and dose-limiting toxicities (Part 1) | From enrollment to the end of treatment | Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs), from first dose of study treatment to 28 days after last dose of study treatment. |
| Area under the curve (AUC) | Up to 30 months | Area under the concentration-time curve (AUC) of KQB198 in combination with imatinib. |
| Maximum plasma concentration (Cmax) | Up to 30 months | Maximum plasma concentration (Cmax) of KQB198 in combination with imatinib. |
| Time to maximum plasma concentration (Tmax) | Up to 30 months | Time to maximum plasma concentration (Tmax) of KQB198 in combination with imatinib. |
Countries
United States
Contacts
CONTACTKumquat Clinical Development
Outcome results
None listed