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Набира участници Фаза 2 NCT07406633

KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting

Фаза 2 – изследване на ефективността и дозировката
Заболявания: GIST - Gastrointestinal Stromal Tumor GIST GIST Metastatic Cancer Gastro Intestinal Stromal Tumour Gastrointestinal Tumors

Спонсор: Kumquat Biosciences Inc.

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
KQB198
DRUG
Imatinib (Gleevec)
DRUG
Места на провеждане 1
САЩ (1)
Cleveland Clinic
Cleveland , Ohio
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.05.2026
Крайна дата
01.10.2028
Регистрационен номер
NCT07406633
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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