Study on the Safety and Effectiveness of AZD7789 for Patients with Advanced or Metastatic Solid Tumors, Including Non-small Cell Lung Cancer and Gastric Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called for people with advanced or metastatic solid tumors. These are types of cancer that have spread to other parts of the body and include conditions like , , and . The treatment being tested is a special kind of medicine known as a , which is designed to target two specific proteins, and , that are involved in the growth of cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of in treating these advanced cancers. The study is divided into two parts. In the first part, the focus is on finding the safest dose of the treatment that can be given to patients. This involves gradually increasing the dose to see how much can be tolerated without causing severe side effects. In the second part, the study will look at how well the treatment works in controlling the cancer and improving the patients’ condition.

Participants in the study will receive the treatment through an infusion, which means the medicine is given directly into the bloodstream. The study will monitor the participants closely to check for any side effects and to see how the cancer responds to the treatment. The goal is to find out if can be a safe and effective option for people with these challenging types of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, organ function, and previous treatments.

A fresh tumor tissue sample is required at the start and during treatment for certain participants.

2 treatment initiation

The treatment involves the administration of AZD7789, a solution for infusion given intravenously.

The dosage and frequency are determined based on the phase of the study and individual response.

3 dose escalation phase

In this phase, the safety and tolerability of AZD7789 are assessed to find the maximum tolerated dose or optimal biological dose.

Participants may experience dose-limiting toxicities, which are closely monitored.

4 dose expansion phase

This phase evaluates the safety and preliminary effectiveness of AZD7789 in a larger group of participants.

The focus is on observing any antitumor activity and further assessing safety.

5 monitoring and assessments

Throughout the study, regular monitoring of vital signs, laboratory parameters, and ECG results is conducted.

Adverse events and any significant changes in health are documented.

6 study completion

The study is estimated to conclude by August 2026.

Final assessments will include the overall response to the treatment and any long-term effects.

Who Can Join the Study?

Must be at least 18 years old.
Must have proper functioning of organs and bone marrow, checked within 28 days before the first dose.
For Part A Dose Escalation:
- May have a type of lung cancer called non-small cell lung carcinoma (NSCLC), which can be squamous or non-squamous.
- Must have had at least one previous treatment, including one with approved anti-PD-1/PD-L1 therapy.
- Must have shown resistance to immune-oncology (IO) treatments.
- PD-L1 expression, a protein level, must be documented as less than 1% or 1% and above.
For Part B Dose Expansion Cohort B1 and B3:
- May have squamous or non-squamous NSCLC.
- Must have had at least one previous treatment, with only one including approved anti-PD-1/PD-L1 therapy.
- Must have shown resistance to IO treatments.
- PD-L1 expression must be documented as 1% and above.
For Part B Dose Expansion Cohort B2 and B5:
- May have squamous or non-squamous NSCLC.
- Must not have had any previous immunotherapy but may have had one prior treatment with standard chemotherapy.
- Cohort B2: PD-L1 expression must be documented as 50% and above.
- Cohort B5: PD-L1 expression must be documented between 1% and 49%.
For Part B Dose Expansion Cohort B4:
- Must have had one or two previous treatments in advanced or metastatic stages, with only one including approved anti-PD-1/PD-L1 therapy.
- Must have shown resistance to IO treatments.
- No specific PD-L1 status is required for this group.
For Part A and Part B Cohorts B1, B2, B3, and B5: Must have documented Stage IIIB to IV NSCLC that cannot be treated with surgery or radiation.
For Part B Cohort B4: Must have documented advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma that cannot be treated with surgery or radiation.
Must have at least one measurable tumor according to specific criteria called RECIST v1.1.
Must provide a fresh tumor tissue sample at screening and during treatment for certain groups. For others, providing an old sample is optional if available.
Must provide an old tumor tissue sample at screening if available.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which indicates the level of daily functioning.
Must have a predicted life expectancy of at least 12 weeks.
Women must not be pregnant, and both female and male participants must agree to use effective birth control methods to avoid pregnancy.

Who Cannot Join the Study?

Patients who have a different type of cancer than those specified in the study.
Patients who are not within the age range specified for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have a medical condition that the study doctors think might make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent surgery or medical procedure that might interfere with the study.
Patients who have an infection or illness that could affect the study results.
Patients who have a history of allergic reactions to similar medications.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Netherlands Cancer Institute	Amsterdam	The Netherlands
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Axgqsrqagz Pnccitsn Hitpxffo Do Myzvkhbhy	Marseille	France
Hdrwmfly Vrru dckimyyp	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	26.10.2021
Spain	Not recruiting	26.10.2021
The Netherlands	Not recruiting	26.10.2021

Trial locations

Investigated drugs:

Sabestomig

AZD7789 is a new type of treatment being studied for its potential to help people with advanced or metastatic solid tumors. It is a bispecific antibody, which means it is designed to target two specific proteins in the body, PD-1 and TIM-3. These proteins are involved in the immune system’s response to cancer. By targeting both, AZD7789 aims to help the immune system better recognize and attack cancer cells. The study is looking at how safe and tolerable this treatment is, as well as how it behaves in the body and its potential effectiveness against tumors.

Investigated diseases:

Neoplasm malignant

Advanced or Metastatic Non-small Cell Lung Carcinoma – This is a type of lung cancer that begins in the cells lining the lungs and has spread beyond the lungs to other parts of the body. It is characterized by uncontrolled cell growth in lung tissues, which can form tumors. As the disease progresses, it can invade nearby tissues and organs, leading to symptoms such as persistent cough, chest pain, and difficulty breathing. The cancer may also spread to distant organs, a process known as metastasis, which can cause additional symptoms depending on the organs affected.

Advanced or Metastatic Solid Tumors – These are cancers that originate in solid organs or tissues and have progressed to an advanced stage, often spreading to other parts of the body. Solid tumors can occur in various organs, including the breast, prostate, colon, and others. As they grow, they can disrupt normal organ function and may spread to lymph nodes or distant organs. The progression of these tumors can lead to symptoms such as pain, swelling, or organ dysfunction, depending on the location and size of the tumor.

Advanced or Metastatic Gastric and Gastro-esophageal Junction Adenocarcinoma – This is a type of cancer that starts in the glandular cells of the stomach or the area where the stomach meets the esophagus. In advanced stages, the cancer has spread beyond the stomach or gastro-esophageal junction to other parts of the body. The disease can cause symptoms such as difficulty swallowing, weight loss, and abdominal pain. As it progresses, it may invade nearby tissues and organs, leading to further complications and symptoms.

Trial ID:

2022-502774-17-00

Protocol code:

D9570C00001

NCT ID:

NCT04931654

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effectiveness of AZD7789 for Patients with Advanced or Metastatic Solid Tumors, Including Non-small Cell Lung Cancer and Gastric Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?