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Набира участници Фаза 1 NCT06707610

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Advanced Cancer Advanced Solid Tumor

Спонсор: Shanghai Allink Biotherapeutics Co., Ltd.

Налично на: БГ
Обобщение
TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.
Кой може да участва
Inclusion Criteria: * Men and women ≥18 and ≤75 years old on the day of signing the ICF * At least 1 measurable lesion per RECIST v1.1 * Expected survival ≥3 months * ECOG PS score of 0 or 1 * Adequate organ function * Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods (abstinence, birth control pills, barrier contraception, intra-uterine contraceptive device, etc.) from the date of signing the ICF until at least 6 months after the last dose of ALK202, and during this period, male participants are not allowed to donate sperms. Exclusion Criteria: * Received organ transplant or hematopoietic stem cell transplant previously * Vaccinated with live vaccines within 4 weeks prior to the first dose * Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges * Pregnant or lactating women * Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage. * Evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease). Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Места на провеждане 2
Австралия (1)
Scientia Clinical Research Ltd
Randwick , New South Wales
САЩ (1)
D&H Cancer Research Center Llc
Margate , Florida
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
10.02.2025
Крайна дата
01.12.2028
Регистрационен номер
NCT06707610
Източник
anzctr
Запитване за медицински туризъм

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