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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
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

Study Summary

This trial is testing a new cancer treatment to see if it is safe and effective.

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.Check my eligibility
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.See study design
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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I agree to provide a fresh tumor sample and consent to a biopsy.
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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 organs and bone marrow are functioning well.
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My lung cancer can be squamous or non-squamous.
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My lung cancer can be squamous or non-squamous.
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My stomach cancer cannot be cured with surgery or radiation.
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I can provide a tumor sample or agree to a biopsy if I join the study.
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My lung cancer can be squamous or non-squamous.
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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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My cancer shows PD-L1 expression of 1% or more.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Disease control rate
Duration of response
Immunogenicity of AZD7789
+8 more

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

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,245 Previous Clinical Trials
288,529,056 Total Patients Enrolled

Media Library

AZD7789 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04931654 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1, Dose Expansion Part B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1, Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1, Dose Escalation Part A: NSCLC Immuno-oncology (IO) acquired or primary resistance, Dose Expansion Part B1: NSCLC IO acquired resistance - RP2D level 1, Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2
Non-Small Cell Lung Cancer Clinical Trial 2023: AZD7789 Highlights & Side Effects. Trial Name: NCT04931654 — Phase 1 & 2
AZD7789 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04931654 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies open to participants in this clinical trial?

"Affirmative. The information located on clinicaltrials.gov implies that this medical trial is in the process of enrolling participants. It was initially published on September 28th 2021 and most recently updated on November 17th 2022; with 81 patients to be enrolled from 4 different locations."

Answered by AI

Is this trial open to participants of the geriatric age range?

"According to the requirements, individuals between 18 and 130 years old can apply for this medical research. There are 21 trials specifically designed for a younger cohort while 1358 studies target elderly patients."

Answered by AI

What benefits are anticipated from this research?

"According to AstraZeneca, the clinical trial's primary endpoint is evaluating the anti-tumour activity of AZD7789 over a span of 18 months. Additionally, secondary endpoints such as duration of response, immunogenicity and pharmacokinetic measurements will also be evaluated."

Answered by AI

How many participants are included in this clinical experiment?

"Affirmative, according to clinicaltrials.gov the trial posted on September 28th 2021 is currently in progress. The most recent update was made on November 17th 2022 and 81 participants are hoped to be recruited from 4 different medical locations."

Answered by AI

Are any locations in North America hosting this experiment?

"At the moment, 4 sites are taking on participants in this trial; Toronto, New york and Nashville being a few of them. To limit travelling needs during your involvement, select the closest site possible to you."

Answered by AI

Is it possible to join this research program?

"This clinical trial is currently recruiting 81 individuals with carcinoma, non-small cell lung. To be eligible for the study, participants must meet the following criteria: age between 18 and 130; histologically or cytologically documented Stage IIIB to IV NSCLC that cannot be cured by surgery or radiation; ECOG performance status of 0 or 1; not pregnant (women) and willing to avoid pregnancy (or men willing to use highly effective contraception); adequate organ and bone marrow function measured within 28 days before first dose; squamous/non-squamous NSCLC diagnoses accepted but at least one prior line of systemic therapy containing approved PD"

Answered by AI
~76 spots leftby Jul 2025