KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KQB198, Imatinib (Gleevec).
- Who it may be relevant to
- Registry conditions: GIST - Gastrointestinal Stromal Tumor, GIST, GIST Metastatic Cancer, Gastro Intestinal Stromal Tumour. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Multicenter, Study Evaluating the Efficacy, Safety, Tolerability, Pharmacokinetics of KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GI Stromal Tumor in 1st Line Setting
Overview
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
- Drug KQB198
Oral KQB198 - Drug Imatinib (Gleevec)
Oral Imatinib
Primary outcome measures
- Objective response rate (ORR) [Time frame: 30 months]
Secondary outcome measures (9)
- Duration of response (DOR) [Time frame: 30 months]
- Disease control rate (DCR) [Time frame: 30 months]
- Time to response (TTR) [Time frame: 30 months]
- Progression-free survival (PFS) [Time frame: Up to 30 months]
- Overall survival (OS) [Time frame: Up to 30 months]
- Number of patients who experience treatment-emergent adverse advents, serious adverse events, and dose-limiting toxicities (Part 1) [Time frame: From enrollment to the end of treatment]
- Area under the 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 16 centers
- USC Norris Comprehensive Cancer Center — Los Angeles
- Mayo Clinic - Jacksonville — Jacksonville
- Sylvester Comprehensive Cancer Center — Miami
- Moffitt Cancer Center — Tampa
- University of Chicago Medical Center — Chicago
- University of Iowa Health Care — Iowa City
- Dana-Farber Cancer Institute — Boston
- University of Michigan Hospitals — Ann Arbor
- … and 8 more centers
Identifiers
NCT: NCT07406633 · KQB198-103