Study on AZD0901 and Drug Combination for Patients with Advanced Gastric, Gastroesophageal, and Pancreatic Cancers Expressing Claudin 18.2

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What is this study about?

This clinical trial is focused on studying advanced forms of certain cancers, specifically Gastric Cancer, Gastroesophageal Junction Cancer, and Pancreatic Ductal Adenocarcinoma. The trial will explore the effects of a new treatment called AZD0901, which is being tested both on its own and in combination with other anti-cancer medications. These medications include Onivyde (containing irinotecan), Bendafolin (containing folinic acid), Gemcitabin HEXAL (containing gemcitabine), and Benda-5 FU (containing fluorouracil). The purpose of the study is to investigate the safety and tolerability of AZD0901 and to evaluate its preliminary anti-tumor activity in patients with advanced or metastatic solid tumors that express a protein called Claudin 18.2.

Participants in the study will receive treatments through intravenous infusions, which means the medication is delivered directly into the bloodstream through a vein. The study will monitor the participants over time to assess how well they tolerate the treatment and to observe any changes in their cancer. The trial will also look at how the body processes AZD0901 and whether the immune system reacts to it. The study aims to gather information on the overall survival of participants, how long they live without the cancer getting worse, and how long any positive response to the treatment lasts.

Throughout the study, researchers will collect data on the size of the tumors and any changes that occur. They will also investigate the relationship between certain genetic or protein markers in the tumors and the effectiveness of the treatment. This information will help determine if AZD0901 could be a beneficial treatment option for patients with these types of cancers. The study is expected to continue until 2027, with recruitment of participants starting in late 2024.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and previous treatments.

A biopsy may be required to confirm the presence of a specific protein, Claudin 18.2, in the tumor.

2 initial assessment

An initial assessment is conducted to evaluate overall health, including physical examination, laboratory tests, and imaging studies.

This assessment helps establish a baseline for monitoring changes during the trial.

3 treatment phase

The treatment phase involves receiving AZD0901 either alone or in combination with other cancer medications.

Medications are administered through an intravenous infusion, which means they are given directly into a vein.

The specific medications used may include irinotecan, folinic acid, gemcitabine, and fluorouracil.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and effectiveness of the treatment.

This includes checking for side effects, changes in laboratory results, and tumor response through imaging studies.

Follow-up visits are scheduled at intervals determined by the study protocol.

5 end of treatment

At the end of the treatment phase, a final assessment is conducted to evaluate the overall response to the therapy.

Participants may continue to be monitored for a period after treatment to assess long-term effects and overall survival.

Who Can Join the Study?

Participants must be at least 18 years old or the legal age of consent.
For Sub study 1: Participants must have a confirmed type of cancer called adenocarcinoma in the stomach or where the stomach meets the esophagus.
For Sub study 1: The cancer must be advanced or have spread to other parts of the body.
For Sub study 1: Participants must provide a sample of their tumor, either from a previous test or a new one, depending on when they join the study.
For Sub study 1: Participants can have had up to two previous treatments for cancer that cannot be removed by surgery or has spread, but not certain types of treatments targeting CLDN18.2 or a specific drug type called MMAE ADC.
For Sub study 2: Participants must have a confirmed type of cancer called metastatic or advanced PDAC (pancreatic ductal adenocarcinoma).
For Sub study 2: Participants must provide a sample of their tumor, either from a previous test or a new one.
For Sub study 2: Participants must not have had any previous treatments for cancer that cannot be removed by surgery or has spread, except for certain types of chemotherapy given before or after surgery if the cancer progressed at least 6 months after the last dose.
Participants must have a positive test result for CLDN18.2, a specific protein, from a previous study or provide a new sample if they had previous treatments targeting this protein.
Participants must have at least one tumor that can be measured according to specific guidelines called RECIST v.1.1.
Participants must have a good general health status, known as ECOG performance status of 0 to 1, with no worsening in the last 2 weeks before starting the study.
Participants must have a life expectancy of at least 12 weeks.
Participants must have proper functioning of their organs and bone marrow, as defined by the study rules.
Participants must weigh more than 35 kg (about 77 pounds).
Participants must agree to follow the study’s rules about using contraception.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied, such as Gastric Cancer, Gastroesophageal Junction Cancer, or Pancreatic Ductal Adenocarcinoma.
Patients who do not have advanced or metastatic solid tumors. Metastatic means the cancer has spread to other parts of the body.
Patients whose tumors do not express CLDN18.2, a specific protein found in some cancer cells.
Patients who are not within the specified age range for the study.
Patients who are not able to safely tolerate the study treatment.
Patients who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Nkdshfsl Iepwotni Ogkpazpkz Idf Mbvvf Sldizckpvqcnisouuuhznygglnlw Iuckrbyp Bydxpsoq	Cracow	Poland
Hthfagod Vrry dgqtfszc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	20.11.2024
Spain	Recruiting	20.11.2024

Trial locations

Investigated drugs:

AZD0901 is an investigational medication being studied for its potential to treat advanced or metastatic solid tumors that express a specific protein called Claudin 18.2. This medication is being tested to see how safe and tolerable it is for patients, as well as to evaluate its effectiveness in reducing tumor size or slowing tumor growth. AZD0901 is being used both on its own and in combination with other anti-cancer medications to determine the best approach for treating these types of tumors.

Investigated diseases:

Gastric Cancer – Gastric cancer, also known as stomach cancer, begins in the cells lining the stomach. It often starts in the mucus-producing cells on the stomach’s inner surface. As it progresses, the cancer can invade deeper layers of the stomach wall and spread to nearby organs. Symptoms may include indigestion, stomach pain, nausea, and weight loss. The disease can spread to lymph nodes and other parts of the body. Early stages may not show significant symptoms, making it challenging to detect initially.

Gastroesophageal Junction Cancer – This type of cancer occurs where the esophagus meets the stomach. It often starts in the cells lining this junction and can affect swallowing and digestion. As it progresses, it may cause symptoms like difficulty swallowing, chest pain, and weight loss. The cancer can spread to nearby lymph nodes and other organs. It is often associated with conditions like gastroesophageal reflux disease (GERD). Early detection can be difficult due to subtle initial symptoms.

Pancreatic Ductal Adenocarcinoma – This is the most common type of pancreatic cancer, originating in the ducts of the pancreas. It typically grows quickly and can spread to nearby organs, including the liver and lungs. Symptoms may include jaundice, abdominal pain, and weight loss. The disease often remains undetected until it is advanced due to its deep location in the abdomen. It can affect the pancreas’s ability to produce digestive enzymes and insulin. Early symptoms are often vague, contributing to late diagnosis.

Trial ID:

2023-508275-37-00

Protocol code:

CLARITY-PT01

NCT ID:

NCT06219941

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on AZD0901 and Drug Combination for Patients with Advanced Gastric, Gastroesophageal, and Pancreatic Cancers Expressing Claudin 18.2

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?