RECRUITING

AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

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 (CLARITY Gastric 01)

Quick Facts

Study Start:2024-03-04
Study Completion:2026-10-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06346392

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Capable of giving signed informed consent prior to any study procedure.
  2. 2. 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.
  3. 3. Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement:
  4. 4. Disease progression on or after at least one prior line of treatment (LoT) for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
  5. 5. Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1.
  6. 6. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
  7. 7. Predicted life expectancy of ≥ 12 weeks.
  8. 8. Adequate organ and bone marrow function
  9. 9. Body weight of ≥ 35 kg.
  10. 10. Sex and Contraceptive Requirements
  1. 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. 2. Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
  3. 3. 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.
  4. 4. Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
  5. 5. Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss).
  6. 6. Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatment other than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy, multi-specific antibody including targeting CLDN18.2, etc).

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35233
United States
Research Site
Mobile, Alabama, 36604
United States
Research Site
Tucson, Arizona, 85719
United States
Research Site
Duarte, California, 91010
United States
Research Site
Fullerton, California, 92835
United States
Research Site
Irvine, California, 92618
United States
Research Site
Los Angeles, California, 90048
United States
Research Site
Los Angeles, California, 90089
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
Santa Rosa, California, 95403
United States
Research Site
Washington, District of Columbia, 20007
United States
Research Site
Hollywood, Florida, 33021
United States
Research Site
Orlando, Florida, 32803
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Marietta, Georgia, 30060
United States
Research Site
Honolulu, Hawaii, 96819
United States
Research Site
Boise, Idaho, 83712
United States
Research Site
Lexington, Kentucky, 40536
United States
Research Site
Baltimore, Maryland, 21287
United States
Research Site
Boston, Massachusetts, 02114
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Kansas City, Missouri, 64111
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
Saint Louis, Missouri, 63128
United States
Research Site
Mineola, New York, 11501
United States
Research Site
New York, New York, 10016
United States
Research Site
New York, New York, 10032
United States
Research Site
New York, New York, 10065
United States
Research Site
Cincinnati, Ohio, 45219
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Philadelphia, Pennsylvania, 19111
United States
Research Site
Charlottesville, Virginia, 22908
United States
Research Site
Olympia, Washington, 98502
United States
Research Site
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-04
Study Completion Date2026-10-09

Study Record Updates

Study Start Date2024-03-04
Study Completion Date2026-10-09

Terms related to this study

Keywords Provided by Researchers

  • Gastric cancer
  • Gastroesophageal junction cancer
  • Phase III
  • Claudin 18.2
  • AZD0901

Additional Relevant MeSH Terms

  • Gastric Cancer
  • Gastroesophageal Junction Cancer