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Study on the Safety and Effectiveness of AZD0022 Alone and with Other Cancer Drugs for Adults with KRAS-G12D Mutated Tumors in Lung, Colorectal, and Pancreatic Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying certain types of cancer, specifically Non-Small Cell Lung Cancer, Colorectal Cancer, and Pancreatic Ductal Adenocarcinoma. The study is investigating a new treatment called AZD0022, which is a type of medication taken as a film-coated tablet. The trial will explore how safe and effective AZD0022 is when used alone and in combination with other cancer treatments. The study is particularly interested in patients whose tumors have a specific genetic change known as the KRAS-G12D mutation.

The purpose of the study is to learn more about the safety and potential benefits of AZD0022 for people with these cancers. Participants will receive the medication and be monitored to see how their bodies respond. Some participants may receive AZD0022 alone, while others may receive it alongside other cancer drugs. The study will also look at how the drug moves through the body over time. This information will help researchers understand the best way to use AZD0022 in treating these cancers.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their cancer. The study will also collect information on any side effects experienced by participants. This trial is an important step in finding new ways to treat cancers with the KRAS-G12D mutation and could lead to new treatment options for patients in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of a KRASG12D mutation in the tumor, which can be identified through a pre-existing test result or a new test if necessary.
A comprehensive review of medical history and current health status is performed to ensure all criteria are met.
Step 2
Treatment initiation
The treatment phase begins with the administration of AZD0022 as a monotherapy or in combination with other anti-cancer agents. The specific regimen depends on the part of the study the participant is enrolled in.
For oral administration, AZD0022 is provided in the form of film-coated tablets. The dosage and frequency are determined based on the study protocol.
Step 3
Monitoring and evaluation
Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes checking vital signs, laboratory parameters, and performing ECGs.
Participants are evaluated for any adverse effects or significant changes in health status. Adjustments to the treatment may be made based on these evaluations.
Step 4
Dose escalation and optimization
In certain parts of the study, dose escalation is performed to determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) of AZD0022.
Participants may undergo additional assessments to optimize the dosage for maximum efficacy and minimal side effects.
Step 5
Efficacy assessment
The anti-tumor activity of AZD0022 is assessed through imaging studies and other diagnostic tests to evaluate the response of the tumor to the treatment.
The overall response rate (ORR) and other measures of efficacy are determined according to standardized criteria.
Step 6
Completion and follow-up
Upon completion of the treatment phase, participants undergo a final evaluation to assess the overall impact of the treatment.
Long-term follow-up may be conducted to monitor the participant's health and any lasting effects of the treatment.

Who can join the trial?

10 criteria

Must be able to give signed informed consent, which means agreeing to follow the study rules and understanding what the study involves.
Must be at least 18 years old or the legal age of consent in the area where the study is happening.
Must have a confirmed advanced or spreading tumor, which means the cancer has grown or spread to other parts of the body.
Must have a specific genetic change in the cancer called a KRASG12D mutation. This can be confirmed by a test done before or during the study.
Must have tried standard treatments for their type of cancer and either not responded, stopped working, or couldn't tolerate them.
Must provide a sample of the tumor for testing.
Must have at least one measurable tumor that can be tracked during the study.
Must have organs and bone marrow that are working well enough, as shown by specific medical tests.
For certain parts of the study, must be willing to provide additional tumor samples and be in a stable condition to handle the procedure.
For some parts of the study, must be able to eat a high-fat meal and fast for a certain period as part of the study requirements.

Who cannot join the trial?

5 criteria

Patients who do not have advanced tumors with a specific genetic change called a KRASG12D mutation cannot participate. This mutation is a change in a gene that can affect how cancer grows.
Patients who are not diagnosed with one of the following cancers: Non-Small Cell Lung Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma cannot participate. These are specific types of cancer affecting the lungs, colon, and pancreas.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to safely tolerate the study treatment cannot participate. This means if the treatment could cause harm or severe side effects, they will not be included.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate. This includes groups like children or those unable to make decisions for themselves.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centro Ricerche Cliniche Di Verona S.r.l.
Verified
Verona, Italy
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

Trial locations

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Investigated drugs

AZD0022 is an investigational medication being studied for its potential to treat advanced tumors that have a specific genetic mutation known as KRASG12D. This medication is being tested both on its own and in combination with other anti-cancer drugs to see how well it works and how safe it is for patients. The study aims to find the best dose that patients can tolerate while also looking at how effective the medication is in shrinking or controlling the tumors.

What is already known about the treatment

AZD0022 – This medication is administered orally and is currently being studied in clinical trials for its safety, tolerability, and effectiveness in treating certain types of cancer, including non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. It is specifically targeted at tumors with a KRASG12D mutation. AZD0022 works by inhibiting specific pathways that cancer cells use to grow and divide, aiming to slow down or stop tumor progression. It is classified as an investigational anti-cancer agent, and its use is still under research to determine its full potential and application in cancer therapy.

Investigated diseases

Non-Small Cell Lung Cancer
This is the most common type of lung cancer, accounting for about 85% of cases. It typically starts in the epithelial cells lining the lungs and can grow and spread to other parts of the body. The disease progresses through stages, beginning with localized tumors and potentially advancing to more widespread metastasis. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression can vary significantly among individuals, influenced by factors such as genetic mutations and overall health.
Colorectal Cancer
This cancer affects the colon or rectum, often starting as benign polyps that can become cancerous over time. It can grow into the wall of the colon or rectum and spread to nearby lymph nodes and other organs. Symptoms might include changes in bowel habits, blood in the stool, and abdominal discomfort. The disease progresses through stages, from localized growths to more advanced metastatic disease. Early detection is crucial for managing its progression.
Pancreatic Ductal Adenocarcinoma
This is the most common type of pancreatic cancer, originating in the ducts of the pancreas. It tends to grow and spread quickly, often reaching advanced stages before detection. Symptoms can include jaundice, weight loss, and abdominal pain. The disease progresses as the cancer cells invade nearby tissues and organs, and potentially spread to distant sites. Its aggressive nature makes early detection challenging.