Carcinoma, Non-Small-Cell LungPhase 1/2NCT04931654
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
A Phase 1/2 study testing AZD7789 in people with Carcinoma, Non-Small-Cell Lung and Gastric Cancer, run by AstraZeneca at 21 sites in 10 countries.
Trial summary
This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- AZD7789
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 21 sitesin 10 countries
- Study dates
- 28 Sep 2021to 12 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be ≥ 18 years of age
- Part A Dose-escalation cohorts and Part B Dose-expansion cohorts B1, B2, B3 and B5: Histologically or cytologically documented Stage IIIB to IV non-small cell lung carcinoma (NSCLC) not amenable to curative surgery or radiation.
- Part B Dose-expansion cohort B4: Histologically or cytologically documented advanced or metastatic gastric and gastro-esophageal junction adenocarcinoma (GEJC) not amenable to curative surgery or radiation.
- Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Provision of archival or fresh tumor tissue sample and/or consent to undergo mandatory on-treatment biopsy for participants enrolled in Part A Dose-escalation
- Provision of archival tumor tissue sample or fresh tissue sample for Part B Dose-expansion cohorts B1, B2, B3 and B5. Provision of fresh tumor tissue sample and consent to undergo mandatory on-treatment biopsy for cohort B4.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Non-pregnant women and willingness of female participants to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception
- Adequate organ and bone marrow function measured within 28 days prior to first dose
- Part A Dose Escalation Additional Inclusion Criteria:
- May have squamous or non-squamous NSCLC
- 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
- Must have had immune-oncology (IO) acquired or primary resistance
- PD-L1 expression < 1% or ≥ 1% documented
- Part B Dose Expansion Cohort B1 and B3 Additional Inclusion Criteria:
- May have squamous or non-squamous NSCLC
- Must have received at least one prior line of systemic therapy, of which only one prior line of therapy contained approved anti-PD-1/PD-L1
- Must have had IO acquired resistance
- PD- L1 expression ≥ 1% documented
- Part B Dose Expansion Cohort B2 and B5 Additional Inclusion Criteria:
- May have squamous or non-squamous NSCLC
- Must not have received prior IO therapy in the first-line setting, but may have received one prior treatment regime of platinum-based chemotherapy
- Cohort B2: PD-L1 expression ≥ 50% documented
- Cohort B5: PD-L1 expression 1-49% documented
- Part B Dose Expansion Cohort B4 Additional Inclusion Criteria:
- Must have received at least one but no more than two prior lines of systemic therapy, of which only one prior line of therapy contained an approved anti-PD-1/PD-L1
- Must have had IO acquired resistance
- There are no PD-L1 status requirements for this cohort
Who cannot join
- Patients with sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions. Documented test result is mandatory for participants with non-squamous NSCLC histology. For participants with squamous NSCLC histology, testing is mandatory only if the participant is a never-smoker or in the presence of a mixed histology.
- Documented test result for any other known genomic alteration for which a targeted first line therapy is approved per local standard of care (SoC)
- Part B Dose-expansion Cohort B4: documented HER2 amplification (unless a SoC including an anti-HER2 therapy has been received); testing is not mandatory if not required per local guidelines.
- Unresolved toxicities of ≥ Grade 2 from prior therapy
- Any prior ≥ Grade 3 immune-mediated adverse event (imAE) while receiving immunotherapy or any unresolved imAE ≥ Grade 2
- Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
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- Symptomatic central nervous system (CNS) metastasis or leptomeningeal disease
- History of symptomatic and objectively confirmed arterial (including myocardial infarction) or venous thromboembolic event within 6 months prior to the first dose of study intervention, unless participant is on treatment with adequate antithrombotic medication and is considered to be stable by the Investigator.
- 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
- History of clinically significant arrythmia as judged by the Investigator
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiomyopathy of any etiology, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, unstable angina pectoris, history of myocardial infarction within the past 6 months, serious chronic gastrointestinal conditions associated with diarrhea, active non infectious skin disease. Part B Dose-expansion Cohort B4, medication-resistant ascites requiring drainage in the last 28 days prior the start of AZD7789 and/or the occurrence of active gastro-intestinal bleeding, as judged by the Investigator.
- Active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease (eg, colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.. Some exceptions have been specified in the protocol
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
- Major surgical procedure within 28 days prior to the first dose of study intervention or still recovering from prior surgery
- Other invasive malignancy within 2 years prior to screening
- Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment
- Any previous treatment with anti-TIM-3 therapy in any setting is not permitted. For Part A, Cohorts B1 and B3:treatment with investigational therapy prior to initiation of study treatment except where the most recent line of therapy was investigational agents added to approved anti-PD-1/PD-L1 as part of standard care. Investigational agents may be given as prior lines of therapy (other than the most recent line) and as monotherapy. Where investigational agents are the most recent line of therapy, they must be given in combination with approved anti-PD-1/PD-L1. For Part B Dose-expansion Cohort B4: investigational agents, other than investigational immune checkpoint inhibitors or other IO agents, may be given as any prior lines of therapy.
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study intervention
- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer-related conditions is acceptable.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention Note: Participants should not receive live vaccine while receiving study intervention and up to 30 days after the last dose of study intervention
- Radiotherapy treatment to the lung within ≤ 4 weeks of the first dose of AZD7789. Palliative bone radiotherapy is allowed if ≥ 2 weeks prior to the first dose of AZD7789.
Trial locations and contacts
21 sites in 10 countries.
21 sites in 10 countries
United States4 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Fort Wayne, Indiana, 46804
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10029
Turkey (Türkiye)4 sites
Research Site
Ankara, 06010
Research Site
Ankara, 06200
Research Site
Ankara, 06800
Research Site
Cordaleo, 35575
France3 sites
Research Site
Bordeaux, 33076
Research Site
Rennes, 35000
Research Site
Villejuif, 94805
About this study
Official title: A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Participants With Advanced or Metastatic Solid Tumors.
This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumors.
Read the detailed description
This first time in patients, open-label, multi-centre study will have AZD7789 administered intravenously (IV) to participants with advanced solid tumors. This study will have 2 parts: Part A which will have dose escalation cohorts and Part B which will have the dose expansion cohorts.
- Being tested
- AZD7789
- Keywords
- Solid tumor, Non-small cell lung cancer, NSCLC, Gastric Cancer, Gastroesophageal Junction Cancer, anti-PD-1/PD-L1, anti-TIM-3
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7789Drug
anti-PD-1 and anti-TIM-3 bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Part A: NSCLC Immuno-oncology (IO) acquired or primary resistance | Experimental | AZD7789 monotherapy Receives: Drug: AZD7789 |
| Dose Expansion Part B1: NSCLC IO acquired resistance - RP2D level 1 | Experimental | AZD7789 Monotherapy Receives: Drug: AZD7789 |
| Dose Expansion Part B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1 | Experimental | AZD7789 Monotherapy Receives: Drug: AZD7789 |
| Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2 | Experimental | AZD7789 Monotherapy Receives: Drug: AZD7789 |
| Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1 | Experimental | AZD7789 monotherapy Receives: Drug: AZD7789 |
| Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1 | Experimental | AZD7789 monotherapy Receives: Drug: AZD7789 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AE), serious adverse events (SAE) and immune-mediated AEs (imAE)
Number of participants with AEs, SAEs, imAEs including AEs leading to discontinuation of study intervention and clinically significant alterations in vital signs, laboratory parameters and ECG results
Measured: From time of Informed Consent to 90 days post last dose of study intervention
Number of participants with dose-limiting toxicity (DLT), as defined in the protoocol
A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
Measured: From the first patient until the end of the dose escalation period; approximately 18 months.
Preliminary anti-tumour activity of AZD7789
Objective response rate as defined by RECIST v1.1
Measured: From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.
Secondary outcomes (11)
Objective response rate
Objective response rate as defined by RECIST v1.1
Measured: From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.
Disease control rate
The percentage of participants according to RECIST v1.1 with a response or stable disease
Measured: From first documented response to confirmed progressive disease or death; approximate duration of 4 years.
Duration of response
The time from first response according to RECIST v1.1 until progression or death
Measured: From first documented response to confirmed progressive disease or death; approximate duration of 4 years.
Progression-free survival
The time from first dose of study intervention until the date of objective disease progression or death
Measured: From first dose of study intervention to confirmed progressive disease or death; approximate duration of 4 years.
Overall survival
The time from first dose of study intervention until death due to any cause
Measured: From first dose of study intervention to death. Overall survival will be monitored for the duration of the study, which will last approximately 4 years.
Pharmacokinetics of AZD7789: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma concentration of the study drug.
Measured: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Immunogenicity of AZD7789
The number and percentage of participants who develop detectable anti-drug antibodies (ADA).
Measured: From first dose of study intervention, at predefined intervals throughout the administration of study intervention. A duration of approximately 4 years.
Pharmacokinetics of AZD7789: Area Under the concentration-time curve (AUC)
Area under the plasma concentration-time curve.
Measured: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Pharmacokinetics of AZD7789: Clearance
A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time.
Measured: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Pharmacokinetics of AZD7789: Terminal elimination half-life (t 1/2)
Terminal elimination half life.
Measured: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Preliminary anti-tumour activity of AZD7789: Changes in circulating tumor DNA (ctDNA)
Changes in ctDNA between baseline and on treatment.
Measured: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start28 Sep 2021
- Primary completion4 Dec 2024
- Study completion12 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a FTIH, multicenter, open-label, dose-escalation and dose-expansion study. The study includes 2 parts: Part A Dose Escalation and Part B Dose Expansion. Initially, participants with Stage IIIB to IV NSCLC will be enrolled in the study; additional tumor types may be explored and added in a future amendment to the CSP.
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931654
- Sponsor's protocol ID
- D9570C00001
- Other IDs
- 152970, 2022-502774-17, 2021-000036-57
- Status last verified
- Oct 2025
- First submitted
- 26 May 2021
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Participants With Advanced or Metastatic Solid Tumors.
- ClinicalTrials.gov ID
- NCT04931654
- Acronym / sponsor ID
- D9570C00001
- Keywords
- Solid tumor, Non-small cell lung cancer, NSCLC, Gastric Cancer, Gastroesophageal Junction Cancer, anti-PD-1/PD-L1, anti-TIM-3
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 12 Aug 2026 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumors.
Detailed description
This first time in patients, open-label, multi-centre study will have AZD7789 administered intravenously (IV) to participants with advanced solid tumors. This study will have 2 parts: Part A which will have dose escalation cohorts and Part B which will have the dose expansion cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This is a FTIH, multicenter, open-label, dose-escalation and dose-expansion study. The study includes 2 parts: Part A Dose Escalation and Part B Dose Expansion. Initially, participants with Stage IIIB to IV NSCLC will be enrolled in the study; additional tumor types may be explored and added in a future amendment to the CSP.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Part A: NSCLC Immuno-oncology (IO) acquired or primary resistance | Experimental | Drug: AZD7789AZD7789 monotherapy |
| Dose Expansion Part B1: NSCLC IO acquired resistance - RP2D level 1 | Experimental | Drug: AZD7789AZD7789 Monotherapy |
| Dose Expansion Part B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1 | Experimental | Drug: AZD7789AZD7789 Monotherapy |
| Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2 | Experimental | Drug: AZD7789AZD7789 Monotherapy |
| Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1 | Experimental | Drug: AZD7789AZD7789 monotherapy |
| Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1 | Experimental | Drug: AZD7789AZD7789 monotherapy |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Must be ≥ 18 years of age
- Part A Dose-escalation cohorts and Part B Dose-expansion cohorts B1, B2, B3 and B5: Histologically or cytologically documented Stage IIIB to IV non-small cell lung carcinoma (NSCLC) not amenable to curative surgery or radiation.
- Part B Dose-expansion cohort B4: Histologically or cytologically documented advanced or metastatic gastric and gastro-esophageal junction adenocarcinoma (GEJC) not amenable to curative surgery or radiation.
- Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Provision of archival or fresh tumor tissue sample and/or consent to undergo mandatory on-treatment biopsy for participants enrolled in Part A Dose-escalation
Key exclusion criteria (22 listed)
- Patients with sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions. Documented test result is mandatory for participants with non-squamous NSCLC histology. For participants with squamous NSCLC histology, testing is mandatory only if the participant is a never-smoker or in the presence of a mixed histology.
- Documented test result for any other known genomic alteration for which a targeted first line therapy is approved per local standard of care (SoC)
- Part B Dose-expansion Cohort B4: documented HER2 amplification (unless a SoC including an anti-HER2 therapy has been received); testing is not mandatory if not required per local guidelines.
- Unresolved toxicities of ≥ Grade 2 from prior therapy
- Any prior ≥ Grade 3 immune-mediated adverse event (imAE) while receiving immunotherapy or any unresolved imAE ≥ Grade 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD7789anti-PD-1 and anti-TIM-3 bispecific antibody | Drug | 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 B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1, Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2, Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1, Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1 |
Primary outcome
Number of participants with adverse events (AE), serious adverse events (SAE) and immune-mediated AEs (imAE)
Time frame: From time of Informed Consent to 90 days post last dose of study intervention
Number of participants with AEs, SAEs, imAEs including AEs leading to discontinuation of study intervention and clinically significant alterations in vital signs, laboratory parameters and ECG results
Number of participants with dose-limiting toxicity (DLT), as defined in the protoocol
Time frame: From the first patient until the end of the dose escalation period; approximately 18 months.
A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
Preliminary anti-tumour activity of AZD7789
Time frame: From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.
Objective response rate as defined by RECIST v1.1
11 secondary outcomes
Objective response rate
Time frame: From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.
Disease control rate
Time frame: From first documented response to confirmed progressive disease or death; approximate duration of 4 years.
Duration of response
Time frame: From first documented response to confirmed progressive disease or death; approximate duration of 4 years.
Progression-free survival
Time frame: From first dose of study intervention to confirmed progressive disease or death; approximate duration of 4 years.
Overall survival
Time frame: From first dose of study intervention to death. Overall survival will be monitored for the duration of the study, which will last approximately 4 years.
Pharmacokinetics of AZD7789: Maximum plasma concentration of the study drug (Cmax)
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Immunogenicity of AZD7789
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention. A duration of approximately 4 years.
Pharmacokinetics of AZD7789: Area Under the concentration-time curve (AUC)
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Pharmacokinetics of AZD7789: Clearance
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Pharmacokinetics of AZD7789: Terminal elimination half-life (t 1/2)
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Preliminary anti-tumour activity of AZD7789: Changes in circulating tumor DNA (ctDNA)
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD7789 in people with Carcinoma, Non-Small-Cell Lung and Gastric Cancer, run by AstraZeneca at 21 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Turkey (Türkiye), France, China, Japan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AE), serious adverse events (SAE) and immune-mediated AEs (imAE) (time frame: From time of Informed Consent to 90 days post last dose of study intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.