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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

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study looks at people with cancers that have spread or cannot be removed, including advanced or metastatic gastric and gastro‑esophageal junction adenocarcinoma, advanced or metastatic non‑small cell lung carcinoma, and other advanced or metastatic solid tumors. The medication being tested is called AZD7789, a laboratory‑made protein that works by attaching to two targets on immune cells, known as anti‑PD‑1 and anti‑TIM‑3. It is given through an IV (a needle placed in a vein) as a liquid that is slowly infused into the bloodstream.

The purpose of the study is to find out whether AZD7789 is safe and whether it can help shrink tumors in these cancers. In the first part of the trial, small groups of participants receive increasing amounts of the drug to identify the highest dose that most people can tolerate without serious side effects, called the maximum tolerated dose, and to note any dose‑limiting toxicities, which are side effects that stop the dose from being raised further. In the second part, more participants receive the selected dose to see how well the drug works at slowing or shrinking the cancer, measured by the percentage of tumors that get smaller, known as the objective response rate.

Participants will visit the clinic regularly for the IV infusion and for check‑ups that include simple blood tests, a heart test called an ECG, and imaging scans such as CT or MRI to watch the size of the tumors. The scans are evaluated using a system called RECIST, which compares tumor measurements over time, and blood is also tested for ctDNA, tiny pieces of tumor DNA that can give clues about how the cancer is responding. Throughout the study, doctors will monitor for any side effects, changes in vital signs, and overall health to ensure safety while looking for early signs that the treatment may be effective.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

25 criteria

  • 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 trial?

10 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

AZD7789 – This medication is administered as an injection and is currently being studied in clinical trials. It is not yet approved for general medical use. AZD7789 is being investigated for its potential to treat advanced or metastatic non-small cell lung carcinoma, solid tumors, and gastric or gastro-esophageal junction adenocarcinoma. It works by targeting and blocking two proteins, PD-1 and TIM-3, which are involved in the immune system's ability to fight cancer. This medication is classified as a bispecific antibody, which means it can bind to two different targets at the same time, potentially enhancing its effectiveness in treating cancer.

Investigated diseases

  • 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 detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2022-502774-17-00Protocol codeD9570C00001Estimated enrolment232 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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