Gastric CancerPhase 1/2NCT06921928
Study for AZD4360 in Participants With Advanced Solid Tumours
A Phase 1/2 study testing AZD4360 in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by AstraZeneca at 14 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer
- What is being tested?
- AZD4360
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 29 Apr 2025to 16 Dec 2027
- 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
- Participant must be ≥ 18 at the time of signing the ICF.
- Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Minimum life expectancy of 12 weeks in the opinion of the Investigator.
- 4 Adequate organ and marrow function, as defined by protocol.
- 5. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.
- 6. Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G/GEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.
- 7. Participants must have received at least one prior line of systemic therapy in the advanced/metastatic disease.
- 8. At least one measurable lesion according to RECIST v1.1.
Who cannot join
- Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G/GEJC participants.
- Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
- Participants with clinically significant ascites that require drainage.
- Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
- With spinal cord compression or with high risk of paralysis.
- History of non-infectious interstitial lung disease/pneumonitis.
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- Participant has cardiac abnormalities, as defined by protocol.
- History of another primary malignancy within 2 years prior to screening.
- Known serologic status reflecting active hepatitis B or hepatitis C.
- Known HIV infection that is not well controlled.
- Active tuberculosis infection.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
China4 sites
Research Site
Beijing, 100730
Research Site
Chengdu, 610041
Research Site
Shanghai, 201318
Research Site
Wuhan, 430040
United States3 sites
Research Site
Houston, Texas, 77030
Research Site
Providence, Rhode Island, 02903
Research Site
Santa Monica, California, 90404
Japan3 sites
Research Site
Chūōku, 104-0045
Research Site
Kashiwa, 227-8577
Research Site
Kōtoku, 135-8550
United Kingdom2 sites
Research Site
Glasgow, G12 0YN
Research Site
London, EC1A 7BE
About this study
Official title: A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants With Advanced Solid Tumours
The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma
- Being tested
- AZD4360
- Keywords
- Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumours, AZD4360, Claudin 18.2
- Medical subject headings
- Stomach Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4360Drug
Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)
| Study group | Role | What they receive |
|---|---|---|
| AZD4360 Monotherapy | Experimental | AZD4360 Monotherapy Receives: Drug: AZD4360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360
To investigate the safety and tolerability, and to determine the Maximum Tolerated Dose (MTD) and/or a Recommended Phase II Dose (R2PD) of AZD4360 in previously treated participants with advanced solid tumours, through the assessment of Dose Limiting Toxicities, Adverse Events and Severe Adverse Events.
Measured: Through study completion, up to approximately 2 years
Secondary outcomes (11)
Objective Response Rate (ORR)
The percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR).
Radiological response evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Measured: Through study completion, up to approximately 2 years
Duration of Response (DoR)
The time from the date of first documented ORR until date of first documented Progression of Disease (PD) or death.
Radiological response evaluated according to RECIST v1.1.
Measured: Through study completion, up to approximately 2 years
Disease Control Rate (DCR)
The percentage of participants who have a best objective response of confirmed CR or PR or who have Stable Disease for at least 11 weeks after start of treatment to allow for an early assessment within the assessment window.
Radiological response evaluated according to RECIST v1.1.
Measured: Through study completion, up to approximately 2 years
Progression Free Survival (PFS)
The time from the start of treatment until the date of objective PD or death.
Radiological response evaluated according to RECIST v1.1.
Measured: Through study completion, up to approximately 2 years
Overall Survival (OS)
The time from the start of treatment until death due to any cause.
Measured: Through study completion, up to approximately 2 years
Plasma pharmacokinetics (PK) parameters of AZD4360: Plasma concentration
Plasma concentration of AZD4360, total antibody and other analytes.
Measured: Through study completion, up to approximately 2 years
Plamsa PK parameters of AZD4360, total antibody and other analytes: Area Under Curve (AUC)
Area under the plasma concentration versus time curve for AZD4360, total antibody and other analytes.
Measured: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Maximum plasma concentration (Cmax)
Maximum observed plasma concentration of AZD4360, total antibody and other analytes.
Measured: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Time to maximum plasma concentration (tmax)
The time it takes for AZD4360, total antibody and other analytes to reach the maximum plasma concentration after administration of the study drug.
Measured: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Clearance
A pharmacokinetic measurement of the volume of plasma from which AZD4360, total antibody and other analytes are completely removed per unit time.
Measured: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Half-life
The time required for the quantity of AZD4360, total antibody and other analytes to reduce to half of their initial values.
Measured: Through study completion, up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start29 Apr 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion16 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921928
- Sponsor's protocol ID
- D8930C00001
- Other IDs
- 2024-518281-27-00
- Status last verified
- Jul 2026
- First submitted
- 25 Mar 2025
- Last updated
- 31 Jul 2026
- 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 Vivli.org. All requests 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT06921928
- Acronym / sponsor ID
- D8930C00001
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma
- Keywords
- Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumours, AZD4360, Claudin 18.2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 16 Dec 2027 (estimated)
- First posted
- 10 Apr 2025 (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.
The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD4360 Monotherapy | Experimental | Drug: AZD4360AZD4360 Monotherapy |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant must be ≥ 18 at the time of signing the ICF.
- Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Minimum life expectancy of 12 weeks in the opinion of the Investigator.
- 4 Adequate organ and marrow function, as defined by protocol.
- 5. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.
Key exclusion criteria (11 listed)
- Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G/GEJC participants.
- Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
- Participants with clinically significant ascites that require drainage.
- Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
- With spinal cord compression or with high risk of paralysis.
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 |
|---|---|---|
| AZD4360Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2) | Drug | AZD4360 Monotherapy |
Primary outcome
Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360
Time frame: Through study completion, up to approximately 2 years
To investigate the safety and tolerability, and to determine the Maximum Tolerated Dose (MTD) and/or a Recommended Phase II Dose (R2PD) of AZD4360 in previously treated participants with advanced solid tumours, through the assessment of Dose Limiting Toxicities, Adverse Events and Severe Adverse Events.
11 secondary outcomes
Objective Response Rate (ORR)
Time frame: Through study completion, up to approximately 2 years
Duration of Response (DoR)
Time frame: Through study completion, up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Through study completion, up to approximately 2 years
Progression Free Survival (PFS)
Time frame: Through study completion, up to approximately 2 years
Overall Survival (OS)
Time frame: Through study completion, up to approximately 2 years
Plasma pharmacokinetics (PK) parameters of AZD4360: Plasma concentration
Time frame: Through study completion, up to approximately 2 years
Plamsa PK parameters of AZD4360, total antibody and other analytes: Area Under Curve (AUC)
Time frame: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Maximum plasma concentration (Cmax)
Time frame: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Time to maximum plasma concentration (tmax)
Time frame: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Clearance
Time frame: Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Half-life
Time frame: Through study completion, up to approximately 2 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 31 Jul 2026.
- 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 Vivli.org. All requests 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.
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD4360 in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by AstraZeneca at 14 sites in 5 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 8 inclusion and 11 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China, United States, Japan, Germany, United Kingdom. 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?
Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360 (time frame: Through study completion, up to approximately 2 years). 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 31 Jul 2026.