In short
Azd0901 is being studied in several clinical trials for people with advanced cancers, especially gastric and gastroesophageal junction cancer. These trials look at safety, tolerability, and how well Azd0901 works alone or with other cancer drugs in different patient groups.
Key points
- Azd0901 is being tested in clinical trials for several advanced cancers, with the strongest focus on gastric cancer and gastroesophageal junction cancer. The studies include Phase 1, Phase 2, and Phase 3 trials, so they are looking at both early safety and later effectiveness. Some trials study Azd0901 alone, while others study it with chemotherapy or other anticancer drugs. The target groups include people with unresectable, resectable, advanced, or metastatic disease. One trial also focuses on cancers with high CLDN18.2 levels. The main outcomes include safety, tumor response, progression-free survival, overall survival, and pathological complete response.
Clinical trials overview
The trial data show four interventional studies of Azd0901, all marked as authorised. These studies are being done in people with advanced cancers, especially gastric cancer and gastroesophageal junction cancer.
The trials are designed to learn about both safety and how well Azd0901 may work against cancer. Some studies test Azd0901 alone, while others test it with chemotherapy or other anticancer drugs.
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. Another study includes people with locally advanced resectable gastroesophageal adenocarcinoma, meaning surgery may still be possible.
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. The Phase 1 study includes several advanced or metastatic solid tumors, including gastric cancer, gastroesophageal junction cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer.
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. The study is meant to assess whether these novel combinations can improve cancer control.
In the perioperative Phase 2 study, Azd0901 is tested around the time of surgery, which is called perioperative treatment. This trial is looking at whether treatment before surgery can help shrink the tumor and improve the chance of a better surgical result.
The Phase 3 study compares Azd0901 with the investigator’s choice of standard cancer treatment. The listed comparison drugs include irinotecan, Lonsurf, docetaxel, paclitaxel, and Cyramza.
The Phase 1 study looks at Azd0901 alone or with other anticancer drugs in advanced or metastatic solid tumors. It also includes combinations with Bendafolin, gemcitabine, Benda-5 FU, Onivyde pegylated liposomal, and irinotecan Bendalis.
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. 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.
The Phase 1 study is the earliest stage in this set of trials and is focused on safety, tolerability, and early signs of activity. Across the studies, the designs are interventional, meaning participants receive a study treatment rather than only being observed.
Main outcomes being measured
The Phase 2 gastric and gastroesophageal junction study measures objective response rate and progression-free survival at 6 months. 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.
The perioperative Phase 2 study measures safety outcomes such as adverse events, serious adverse events, laboratory findings, vital signs, and ECGs. It also measures pathological complete response, which means no living tumor cells are found in the removed tissue after treatment.
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. 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.
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. They also show that researchers are studying Azd0901 in both gastric and non-gastric cancers, with a strong focus on CLDN18.2-positive disease.
| Trial ID | Phase | Condition | Key focus | Enrollment |
|---|---|---|---|---|
| NCT05702229 | Phase 2 | Locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma | Response rate and 6-month progression-free survival with novel combinations | 341 |
| 2024-516909-23-00 | Phase 2 | Locally advanced resectable gastroesophageal adenocarcinoma | Safety and pathological response around surgery | 150 |
| 2023-508276-11-00 | Phase 3 | Advanced/metastatic gastric or gastroesophageal junction cancers with high CLDN18.2 | Progression-free survival and overall survival versus standard therapy | 563 |
| NCT06219941 | Phase 1 | Advanced/metastatic gastric, gastroesophageal junction, pancreatic ductal adenocarcinoma, and biliary tract cancer | Safety, dose-limiting toxicities, and early response | 364 |