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Набира участници Фаза 1 NCT06720987

A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: KRAS G12C Mutation KRAS G12S Mutation Solid Tumor Malignancies CRC (Colorectal Cancer)

Спонсор: Kumquat Biosciences Inc.

Налично на: БГ
Обобщение
The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.
Кой може да участва
Inclusion Criteria: * PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation. * PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation. * Unresectable or metastatic disease * No available treatment with curative intent * Adequate organ function * Measurable disease per RECIST v1.1 Exclusion Criteria: * Active primary central nervous system tumors * Cardiac abnormalities * Active interstitial lung disease * Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
Интервенции
KQB365
DRUG
Cetuximab
DRUG
KQB198
DRUG
Места на провеждане 11
САЩ (11)
Dana Farber Cancer Institute
Boston , Massachusetts
Cleveland Clinic, Taussig Cancer Institute
Cleveland , Ohio
Sarah Cannon Cancer Institute at HealthONE
Denver , Colorado
NEXT Virginia, LLC
Fairfax , Virginia
START Midwest
Grand Rapids , Michigan
Mayo Clinic, Jacksonville
Jacksonville , Florida
OU Health Stephenson Cancer Center
Oklahoma City , Oklahoma
Sydney Kimmel Cancer Center
Philadelphia , Pennsylvania
Mayo Clinic, Phoenix
Phoenix , Arizona
Mayo Clinic, Rochester
Rochester , Minnesota
NEXT Oncology
San Antonio , Texas
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
04.02.2025
Крайна дата
30.06.2030
Регистрационен номер
NCT06720987
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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