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Набира участници Фаза 1/2 NCT06921928

Study for AZD4360 in Participants With Advanced Solid Tumours

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Gastric Cancer Gastroesophageal Junction Cancer Biliary Tract Cancer Pancreatic Ductal Adenocarcinoma

Спонсор: AstraZeneca

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.
Кой може да участва
Inclusion Criteria: 1. Participant must be ≥ 18 at the time of signing the ICF. 2. Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing. 3. Minimum life expectancy of 12 weeks in the opinion of the Investigator. 4 Adequate organ and marrow function, as defined by protocol. 5\. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol. 6\. Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G/GEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression. 7\. Participants must have received at least one prior line of systemic therapy in the advanced/metastatic disease. 8\. At least one measurable lesion according to RECIST v1.1. Exclusion Criteria: 1. Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G/GEJC participants. 2. Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy. 3. Participants with clinically significant ascites that require drainage. 4. Central nervous system (CNS) metastases or CNS pathology, as defined by protocol. 5. With spinal cord compression or with high risk of paralysis. 6. History of non-infectious interstitial lung disease/pneumonitis. 7. Participant has cardiac abnormalities, as defined by protocol. 8. History of another primary malignancy within 2 years prior to screening. 9. Known serologic status reflecting active hepatitis B or hepatitis C. 10. Known HIV infection that is not well controlled. 11. Active tuberculosis infection.
Интервенции
AZD4360
DRUG
Места на провеждане 18
Китай (4)
Research Site
Beijing
Research Site
Chengdu
Research Site
Shanghai
Research Site
Wuhan
Германия (3)
Research Site
Berlin
NOT_YET_RECRUITING
Research Site
Dresden
Research Site
Frankfurt
Япония (4)
Research Site
Chūōku
Research Site
Kashiwa
Research Site
Kōtoku
Research Site
Sendai
NOT_YET_RECRUITING
Великобритания (4)
Research Site
Glasgow
NOT_YET_RECRUITING
Research Site
Leeds
NOT_YET_RECRUITING
Research Site
London
Research Site
Oxford
NOT_YET_RECRUITING
САЩ (3)
Research Site
Houston , Texas
Research Site
Providence , Rhode Island
Research Site
Santa Monica , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
130 Years
Здрави доброволци
Не
Начална дата
29.04.2025
Крайна дата
16.12.2027
Регистрационен номер
NCT06921928
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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