Active, not yet recruiting
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
NCT No.: NCT06346392
Study Type: Clinical Trial
Phase:
Phase III
Official Title
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
Purpose
We are doing this study to learn more about: the effectiveness and safety of the study drug AZD0901 compared to a standard therapy that will be selected by your study doctor per your disease status (from a choice of ramucirumab + paclitaxel, paclitaxel, docetaxel, irinotecan, or TAS-102; thereafter referred as to Investigator’s Choice of Therapy) and also to better understand the studied disease and associated health problems.
Detailed Description
Eligibility Criteria
Inclusion Criteria
- 1 Capable of giving signed informed consent prior to any mandatory study-specific procedures, sampling, and analyses.
2 Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics initiative research that supports the Genomic Initiative.
3 Participant must be at least 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.
4 Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement:
(a) Participants with positive CLDN18.2 expression defined as tumour cell expression = 25% with IHC at any intensity, as determined prospectively by central IHC testing using the investigational Ventana CLDN18.2 (SP455) IHC assay (prototype assay and/or validated assay or an alternative central test as required) from archival tumor collected within past 24 months or from a fresh biopsy. For participants who have
received prior CLDN18.2 targeting therapies a new biopsy upon progression must be provided for testing to determine CLDN18.2 expression. Participants with unknown CLDN18.2 status or CLDN18.2 tumour cell expression < 25% with IHC at any intensity based on the central test result are ineligible for the study.
(b) Participants must undergo local (or have had) HER2 testing by IHC/ISH.
5 Disease progression on or after at least one prior regimen for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
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Exclusion Criteria
- 1 Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio = 2 or an average HER2 copy number = 6.0 signals/cell are considered positive by ISH). Participants must undergo local (or have had) HER2 testing by IHC/ISH, and the most recent result of HER2 status will be used to determine
the eligibility.
2 Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
3 Active or prior documented autoimmune or inflammatory disorders that required systemic treatment or assessed by Investigator as not appropriate to participate due to undue risk. The following are exceptions to this criterion:
(a) Vitiligo or alopecia.
(b) Hypothyroidism (eg, following Hashimoto’s disease) stable on hormone replacement.
(c) Psoriasis or eczema not requiring systemic treatment.
4 CNS metastases or CNS pathology including: epilepsy, seizures, aphasia, or stroke within 3 months prior to consent, severe brain injury, dementia, Parkinson’s disease, neurodegenerative diseases, cerebellar disease, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases. The following are exceptions to this criterion:
(a) Participants with history of seizures are permitted if no active seizures in last 5 years.
(b) Participants with brain metastases treated, asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to randomization. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrolment.
5 Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
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Keywords and/or Specific Medical Conditions
Sponsors
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