Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Launched by ASTRAZENECA · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying new combination treatments for people with advanced gastric cancer or gastroesophageal junction cancer that cannot be surgically removed or has spread to other parts of the body. The aim is to find out how effective these treatments are, how safe they are, and how well the body handles them. The trial is currently recruiting participants aged 18 and older who have not received prior treatment for their cancer, have a specific protein marker called Claudin18.2, and meet certain health criteria.

If you participate in this trial, you will receive one of the new treatment combinations and be monitored closely by a team of healthcare professionals. They will check how well the treatment is working and manage any side effects you may experience. It’s important to note that individuals with certain conditions, like specific types of HER2-positive cancer or untreated brain metastases, will not be eligible for this study. This trial provides an opportunity to access innovative treatments that may help improve outcomes for patients with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years or older at the time of signing the ICF.
• • Body weight \> 35 kg.
• • Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
• • Has measurable target disease assessed by the Investigator based on RECIST 1.1.
• • ECOG PS zero or one.
• • Life expectancy of at least 12 weeks.
• • Adequate organ and bone marrow function.
• • Has central lab confirmed Claudin18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 or Substudy 6 is open for recruitment.
• Exclusion Criteria:
• • Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by in situhybridisation) or indeterminate gastric or GEJ carcinoma.
• • Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.
• • Participants with ascites which cannot be controlled with appropriate interventions.
• • Active infectious diseases, including tuberculosis, HIV infection, or hepatitis A/B/C.
• • Uncontrolled intercurrent illness.
• • Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
• • History of another primary malignancy.
• • Previous treatment with an immune-oncology agent.
• • Previous treatment with any modalities of Claudin18.2 target therapy or MMAE exposure (when Substudy 3, Substudy 4, or Substudy 6 is open for recruitment).