Study on AZD0901 for Patients with Advanced Solid Tumors Expressing Claudin18.2

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06219941

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, AZD0901, alone and in combination with other cancer treatments for patients with advanced solid tumors that express a specific protein called Claudin18.2.

Patient Parameters

Program Overview

The aim of this study is to evaluate how safe and effective AZD0901 is when used alone or with other cancer drugs in patients with advanced solid tumors that cannot be surgically removed or have spread to other parts of the body. The study will also look at how the body processes the drug and its potential immune response.

Description

This study is open-label and takes place at multiple centers, meaning both the researchers and participants know what treatment is being given. It includes different sub-studies, each focusing on the safety and tolerability of AZD0901.

Sub-study 1 will explore the safety and anti-cancer effects of AZD0901 given alone to patients with advanced or metastatic stomach or esophageal cancer that expresses Claudin18.2. Participants will receive the drug through an IV infusion and will be randomly assigned to one of two groups.

Sub-study 2 will have two parts: an initial safety phase and a dose expansion phase. It will investigate the safety and effectiveness of AZD0901 combined with different chemotherapy drugs in patients with pancreatic cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with adenocarcinoma of the stomach or gastroesophageal junction.
  • Have advanced or metastatic stomach or gastroesophageal cancer.
  • Have had no more than two previous treatments for cancer that cannot be removed or has spread.

Sub-study 2 Specific Inclusion Criteria:

  • Diagnosed with metastatic or advanced pancreatic cancer.
  • Must provide a previous tumor sample or a new biopsy taken during screening.
  • No prior treatments for cancer that cannot be removed or has spread.

Exclusion Criteria

  • Have unstable or active peptic ulcer disease or digestive tract bleeding.
  • Have significant fluid buildup in the abdomen that needs drainage.
  • Have a history of lung inflammation not caused by infection.
  • Have cancer that has spread to the brain or other central nervous system issues.
  • Have nerve damage of grade 2 or higher.
  • Have a history of another primary cancer.
  • Have previously received any MMAE-based ADC or CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.

Sub-study 1 Specific Exclusion Criteria:

  • Have HER2-positive or indeterminate stomach or gastroesophageal cancer.
  • Have any conditions that increase the risk of heart rhythm problems.
  • Are taking medications that affect heart rhythm.

Sub-study 2 Specific Exclusion Criteria:

  • Have a known deficiency in the DPD enzyme.
  • Are using strong inhibitors or inducers of UGT1A1 or CYP3A4 enzymes.

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