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Набира участници Фаза 1 NCT05536141

A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Clear Cell Renal Cell Carcinoma Solid Tumors

Спонсор: Arcus Biosciences, Inc.

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the safety and tolerability of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.
Кой може да участва
Key Inclusion Criteria: * Must have at least one measurable lesion per RECIST guidance * Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 * Disease-specific criteria for dose escalation: * Participants may have any pathologically confirmed solid tumor type where no other treatment options are available * Creatinine clearance ≥ 40 mL/min Disease-specific criteria for dose-expansion: * Histologically confirmed ccRCC * Creatinine clearance ≥ 40 mL/min Key Exclusion Criteria: * Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product * Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous * History of trauma or major surgery within 28 days prior to the first dose of investigational product * For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Места на провеждане 4
Австралия (1)
Chris O'Brien Lifehouse
Camperdown
NOT_YET_RECRUITING
Южна Корея (1)
Asan Medical Center
Seoul
Испания (1)
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona
NOT_YET_RECRUITING
САЩ (1)
University of Alabama at Birmingham
Birmingham , Alabama
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
26.10.2022
Крайна дата
01.03.2029
Регистрационен номер
NCT05536141
Източник
anzctr
Запитване за медицински туризъм

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