An open-label Phase III study of AZD0901 as monotherapy compared to standard therapy at the discretion of the investigator in adult participants with advanced/metastatic gastric cancer or gastroesophageal junction cancer expressing Claudin 18.2.
Summary description of the study
This study will investigate an investigational substance AZD0901 in advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal cancer. AZD0901 is a type of medication known as an antibody-drug conjugate (ADC). ADCs are a type of targeted therapy that delivers cancer drugs directly to cancer cells. AZD0901 recognizes cancer cells by a specific protein called Claudin 18.2. This is one of the proteins that is commonly found on the surface of gastric cancer cells. To be eligible for this study, this protein must be present in sufficient amounts on the cancer cells (expressed). This will be verified prior to inclusion in the study. This study aims to determine how effective (for example, by reducing the growth or spread of cancer) and safe AZD0901 is compared to a standard therapy. The standard therapy will be selected by the investigator based on the disease status (from a selection of Ramucirumab + Paclitaxel, Paclitaxel, Docetaxel, Irinotecan, TAS-102, or Apatinib).
(BASEC)
Intervention under investigation
Participants will be randomly assigned to one of the following treatment groups:
A) AZD0901 2.2 mg/kg administered intravenously every 3 weeks.
B) AZD0901 1.8 mg/kg administered intravenously every 3 weeks.
C) Standard therapy selected by the investigator (visits expected every 3-4 weeks).
The optimal dose of AZD0901 (2.2 mg/kg or 1.8 mg/kg) is currently being determined in preliminary studies. Once this is established, either Arm A or Arm B will be closed early and the inclusion in the study will then continue 1:1 in two groups (AZD0901 or standard therapy).
Treatments will continue until disease progression occurs. They may also continue if there is clinical benefit.
(BASEC)
Disease under investigation
Advanced or metastatic Claudin 18.2-expressing gastric cancer (gastric adenocarcinoma), gastroesophageal junction cancer, or esophageal cancer.
(BASEC)
- Male and female patients (≥18 years) with a histologically confirmed inoperable, locally advanced, or metastatic gastric adenocarcinoma, gastroesophageal junction cancer, or esophageal cancer expressing the protein Claudin 18.2, but not HER2 (=exclusion). - ECOG performance status 0-1 - Adequate organ and bone marrow function - Non-HER2-positive adenocarcinoma with demonstrated CLDN18.2 expression (status confirmed by central laboratory) - Progression on or after at least one prior treatment with a fluoropyrimidine and a platinum agent. (BASEC)
Exclusion criteria
- Significant or unstable gastric bleeding and/or untreated gastric ulcers - Active or previously documented autoimmune or inflammatory diseases requiring systemic treatment. - Brain metastases or central nervous system (CNS) diseases, including: epilepsy, seizures, aphasia, or stroke 3 months prior to consent, severe head injury, dementia, Parkinson's disease, neurodegenerative diseases, cerebellar diseases, severe uncontrolled psychiatric disorders, psychoses, autoimmune diseases involving the CNS. - History of other primary malignancies, except for malignancies such as basal cell carcinoma of the skin and squamous cell carcinoma of the skin, if for example for at least (≥ 2 years) (BASEC)
Trial sites
Bern, Geneva, Lausanne, Zurich
(BASEC)
Sponsor
Silviya Cantatore AstraZeneca Neuhofstrasse 34 6340 Baar silviya.cantatore@astrazeneca.com +41 41 725 75 75
(BASEC)
Contact
Contact Person Switzerland
Clinical Trials Schweiz
+41 41 725 75 75
clinical-trials@clutterastrazeneca.comAstraZeneca AG Neuhofstrasse 34 6340 Baar
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
27.08.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
CLARITY-Gastric01 - A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared with Investigator’s Choice of Therapy in Second- or Later-Line Adult Participants with Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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