What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve immune checkpoint inhibitors such as pembrolizumab, nivolumab, and atezolizumab, either alone or in combination with chemotherapy. Known side effects of these treatments include fatigue, rash, diarrhea, and pneumonitis. Severe (grade 3 or higher) adverse events can include immune-related effects such as colitis, hepatitis, endocrinopathies, and severe pneumonitis. When combined with chemotherapy, additional side effects may include nausea, vomiting, neutropenia, and anemia. The combination of immune checkpoint inhibitors with chemotherapy generally increases the incidence of severe adverse events compared to monotherapy.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab (Keytruda) and nivolumab (Opdivo) are PD-1 inhibitors approved for various settings in NSCLC, often in combination with chemotherapy. Atezolizumab (Tecentriq), a PD-L1 inhibitor, has also been approved for use in combination with chemotherapy. Additionally, combinations of checkpoint inhibitors, such as nivolumab plus ipilimumab (Yervoy), have been approved for first-line treatment of metastatic NSCLC. These treatments aim to enhance the anti-tumor immune response, similar to the dual inhibition strategy of PD-1 and TIM-3 being studied with AZD7789.

What other types of research exist?

Promising alternatives to AZD7789 for NSCLC patients include: 1) Nivolumab plus Ipilimumab, which targets PD-1 and CTLA-4, showing improved outcomes in various trials. 2) Pembrolizumab combined with chemotherapy, which has demonstrated significant survival benefits in PD-L1-unselected, nonsquamous NSCLC. 3) Ramucirumab plus Pembrolizumab, which has shown improved overall survival in patients with progressive disease after initial immunotherapy. These alternatives leverage dual inhibition and combination strategies to enhance anti-tumor immune responses.

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Monoclonal Antibodies

AZD7789 for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have received at least one prior line of systemic therapy, of which at least one prior line of therapy contained approved anti-PD-1/PD-L1 (Part A Dose Escalation Additional Inclusion Criteria)

Histologically or cytologically documented Stage IIIB to IV non-small cell lung carcinoma (NSCLC) not amenable to curative surgery or radiation

Must not have

History of organ transplant or allogenic haematopoietic stem cell transplant

Infectious disease exclusions: Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first documented response to confirmed progressive disease or death; approximate duration of 4 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called AZD7789 that helps the immune system fight advanced solid tumors by blocking proteins that hide cancer cells. It aims to see if the medicine is safe and effective for patients whose cancer has progressed despite other treatments.

Who is the study for?

Adults with advanced or metastatic solid tumors, such as non-small cell lung cancer or stomach cancers, who have had prior treatments but not in the first-line setting. Participants must be able to provide a tumor tissue sample and meet certain health criteria like good organ function and performance status.

What is being tested?

The trial is testing AZD7789, an experimental drug targeting PD-1 and TIM-3 pathways in cancer cells. It's for patients whose cancers haven't responded well to standard treatments. The study will check if this new treatment is safe and effective.

What are the potential side effects?

While specific side effects of AZD7789 are not listed, similar drugs often cause immune-related reactions, fatigue, digestive issues, skin problems, potential inflammation of organs like lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone gland issues (like thyroid disorders) and can increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had treatment before that included anti-PD-1/PD-L1 therapy.

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My lung cancer is at an advanced stage and cannot be cured with surgery or radiation.

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I have not had systemic or immunotherapy as my first treatment.

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My cancer stopped responding to immunotherapy.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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My stomach cancer cannot be cured with surgery or radiation.

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My cancer did not respond to initial immune therapy treatments.

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I've had one treatment before that included anti-PD-1/PD-L1 therapy.

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I've had 1-2 treatments for my condition, only one included anti-PD-1/PD-L1 therapy.

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I can provide a sample of my tumor for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ or stem cell transplant.

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I do not have any active infections like TB, HIV, hepatitis, or COVID-19.

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I have never stopped an immunotherapy treatment because of severe side effects.

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I have a history of lung conditions needing steroid treatment.

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I do not have any serious ongoing illnesses or recent major heart issues.

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I have not received a live vaccine in the last 30 days.

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My cancer has a genetic change that can be treated with approved medicine.

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I have had severe side effects from immunotherapy or still have moderate side effects.

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I have side effects from previous treatments that are still bothersome.

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I have brain metastases or leptomeningeal disease causing symptoms.

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I have not had major surgery in the last 28 days or am still recovering from one.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first documented response to confirmed progressive disease or death; approximate duration of 4 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first documented response to confirmed progressive disease or death; approximate duration of 4 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first documented response to confirmed progressive disease or death; approximate duration of 4 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with adverse events (AE), serious adverse events (SAE) and immune-mediated AEs (imAE)

Number of participants with dose-limiting toxicity (DLT), as defined in the protoocol

Preliminary anti-tumour activity of AZD7789

Secondary study objectives

Disease control rate

Duration of response

Immunogenicity of AZD7789

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1Experimental Treatment1 Intervention

AZD7789 monotherapy

Group II: Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1Experimental Treatment1 Intervention

AZD7789 monotherapy

Group III: Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2Experimental Treatment1 Intervention

AZD7789 Monotherapy

Group IV: Dose Expansion Part B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1Experimental Treatment1 Intervention

AZD7789 Monotherapy

Group V: Dose Expansion Part B1: NSCLC IO acquired resistance - RP2D level 1Experimental Treatment1 Intervention

AZD7789 Monotherapy

Group VI: Dose Escalation Part A: NSCLC Immuno-oncology (IO) acquired or primary resistanceExperimental Treatment1 Intervention

AZD7789 monotherapy

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapies, chemotherapy, and targeted therapies. Immunotherapies, such as those targeting PD-1 (e.g., pembrolizumab) and TIM-3, work by inhibiting immune checkpoints that cancer cells use to evade the immune system, thereby enhancing the body's ability to attack tumor cells. This is particularly relevant for NSCLC patients as these therapies can lead to improved survival rates and are often used in combination with chemotherapy to enhance efficacy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies focus on specific genetic mutations within cancer cells, offering a more personalized treatment approach. The dual inhibition of PD-1 and TIM-3, as studied in AZD7789, aims to further boost the immune response against tumors, potentially offering a new avenue for treatment-resistant NSCLC.