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New drug AZD4360 targets Hard-to-Treat cancers in early trial

NCT ID NCT06921928

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests a new drug called AZD4360 in adults with advanced solid tumours that have a specific marker (CLDN18.2). The drug is an antibody-drug conjugate designed to deliver a toxic payload directly to cancer cells. The trial aims to find the safest dose and see if it shrinks tumours in people with stomach, gastroesophageal junction, bile duct, or pancreatic cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD4360 (an antibody-drug conjugate targeting CLDN18.2)
What this could lead to
If it works, this could point toward a new treatment option for certain advanced stomach, bile duct, or pancreatic cancers.
What could go wrong
This is an early-phase trial with only 117 participants, so the drug may not prove effective or safe enough for wider use. Side effects could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

31 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant must be ≥ 18 at the time of signing the ICF. 2. 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. 3. 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. Exclusion Criteria: 1. 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. 2. 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. 3. Participants with clinically significant ascites that require drainage. 4. Central nervous system (CNS) metastases or CNS pathology, as defined by protocol. 5. With spinal cord compression or with high risk of paralysis. 6. History of non-infectious interstitial lung disease/pneumonitis. 7. Participant has cardiac abnormalities, as defined by protocol. 8. History of another primary malignancy within 2 years prior to screening. 9. Known serologic status reflecting active hepatitis B or hepatitis C. 10. Known HIV infection that is not well controlled. 11. Active tuberculosis infection.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms gastric cancer gastric neoplasm gastroesophageal cancer gastroesophageal junction adenocarcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer Gastric cancer Gastroesophageal junction cancer Pancreatic ductal adenocarcinoma

Contacts and locations

Locations

  • Research Site

    Santa Monica, California, 90404, United States

  • Research Site

    Providence, Rhode Island, 02903, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Beijing, 100730, China

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Shanghai, 201318, China

  • Research Site

    Wuhan, 430040, China

  • Research Site

    Dresden, 01307, Germany

  • Research Site

    Frankfurt, 60488, Germany

  • Research Site

    Chūōku, 104-0045, Japan

  • Research Site

    Kashiwa, 227-8577, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Glasgow, G12 0YN, United Kingdom

  • Research Site

    London, EC1A 7BE, United Kingdom

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