RECRUITING

AZD0901 in Participants With Advanced Solid Tumours 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 assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.

Official Title

A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2.

Quick Facts

Study Start:2023-12-13
Study Completion:2027-01-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06219941

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
  2. * Advanced or metastatic GC/GEJC.
  3. * Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.
  1. * Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC.
  2. * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
  3. * The use of concomitant medications known to prolong the QT/QTc interval.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Research Site
Orange, California, 92868
United States
Research Site
Palo Alto, California, 94304
United States
Research Site
Santa Rosa, California, 95403
United States
Research Site
Louisville, Kentucky, 40202
United States
Research Site
Commack, New York, 11725
United States
Research Site
Providence, Rhode Island, 02903
United States
Research Site
Houston, Texas, 77030
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 Date2023-12-13
Study Completion Date2027-01-19

Study Record Updates

Study Start Date2023-12-13
Study Completion Date2027-01-19

Terms related to this study

Keywords Provided by Researchers

  • Gastric cancer
  • Gastroesophageal junction cancer
  • Pancreatic adenocarcinoma
  • Phase II
  • Claudin 18.2
  • AZD0901

Additional Relevant MeSH Terms

  • Gastric Cancer
  • Gastroesophageal Junction Cancer
  • Pancreatic Adenocarcinoma