Table of contents

• Clinical trials overview
• Who the trials are for
• What researchers are testing
• Trial phases and study designs
• Main outcomes being measured
• Key trials at a glance

Clinical trials overview

The trial data show four interventional studies of Azd0901, all marked as authorised.^[1][2][3][4] These studies are being done in people with advanced cancers, especially gastric cancer and gastroesophageal junction cancer.^[1][3]

The trials are designed to learn about both safety and how well Azd0901 may work against cancer.^[1][3][4] Some studies test Azd0901 alone, while others test it with chemotherapy or other anticancer drugs.^[1][2][4]

Who the trials are for

The target groups include adults with locally advanced unresectable disease, which means the cancer has grown locally and cannot be removed by surgery.^[1] Another study includes people with locally advanced resectable gastroesophageal adenocarcinoma, meaning surgery may still be possible.^[2]

One Phase 3 trial focuses on adults with advanced or metastatic gastric cancer or gastroesophageal junction cancer that has high levels of CLDN18.2, a protein found on some cancer cells.^[3] The Phase 1 study includes several advanced or metastatic solid tumors, including gastric cancer, gastroesophageal junction cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer.^[4]

What researchers are testing

In the Phase 2 master protocol for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, Azd0901 is studied in combination with chemotherapy and other agents such as oxaliplatin, capecitabine, fluorouracil, AZD7789, volrustomig, and rilvegostomig.^[1] The study is meant to assess whether these novel combinations can improve cancer control.^[1]

In the perioperative Phase 2 study, Azd0901 is tested around the time of surgery, which is called perioperative treatment.^[2] This trial is looking at whether treatment before surgery can help shrink the tumor and improve the chance of a better surgical result.^[2]

The Phase 3 study compares Azd0901 with the investigator’s choice of standard cancer treatment.^[3] The listed comparison drugs include irinotecan, Lonsurf, docetaxel, paclitaxel, and Cyramza.^[3]

The Phase 1 study looks at Azd0901 alone or with other anticancer drugs in advanced or metastatic solid tumors.^[4] It also includes combinations with Bendafolin, gemcitabine, Benda-5 FU, Onivyde pegylated liposomal, and irinotecan Bendalis.^[4]

Trial phases and study designs

Two studies are in Phase 2, which usually means researchers are checking early signs of benefit while continuing to monitor safety.^[1][2] One study is in Phase 3, which is a later stage that often compares a new treatment with standard care in a larger group of people.^[3]

The Phase 1 study is the earliest stage in this set of trials and is focused on safety, tolerability, and early signs of activity.^[4] Across the studies, the designs are interventional, meaning participants receive a study treatment rather than only being observed.^[1][2][3][4]

Main outcomes being measured

The Phase 2 gastric and gastroesophageal junction study measures objective response rate and progression-free survival at 6 months.^[1] Objective response rate means the share of participants whose tumors shrink, while progression-free survival means how many people are alive without the cancer getting worse.^[1]

The perioperative Phase 2 study measures safety outcomes such as adverse events, serious adverse events, laboratory findings, vital signs, and ECGs.^[2] It also measures pathological complete response, which means no living tumor cells are found in the removed tissue after treatment.^[2]

The Phase 3 study measures progression-free survival in all randomized participants and overall survival in the 3L+ group, which means people receiving third-line treatment or later.^[3] The Phase 1 study measures safety, dose-limiting toxicities, and early tumor response using RECIST v1.1, a standard system for measuring tumor changes on scans.^[4]

Key trials at a glance

The four trials together show that Azd0901 is being tested across different stages of cancer care, from early safety testing to larger comparative studies.^[1][2][3][4] They also show that researchers are studying Azd0901 in both gastric and non-gastric cancers, with a strong focus on CLDN18.2-positive disease.^[3][4]