Recruiting PHASE1, PHASE2 Gastric Cancer

New treatment option for Gastric Cancer

Official title Study for AZD4360 in Participants With Advanced Solid Tumours

ClinicalTrials.gov ID: NCT06921928

What this study is testing

What is AZD4360?

AZD4360 is an investigational medicine, being studied as a potential treatment for gastric cancer.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 130

You may be able to join if

  • 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\...

You likely can't join if

  • 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...
  • Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of...
  • 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.
See the full eligibility criteria
Who can 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...
What rules you out
  • 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.
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Santa Monica, California, United States
  • Providence, Rhode Island, United States
  • Houston, Texas, United States
  • Beijing, China
  • Chengdu, China
  • Shanghai, China
  • Wuhan, China
  • Berlin, Germany
  • Dresden, Germany
  • Frankfurt, Germany
  • Chūōku, Japan
  • Kashiwa, Japan
  • Kōtoku, Japan
  • Sendai, Japan
  • Glasgow, United Kingdom
  • Leeds, United Kingdom
  • London, United Kingdom
  • Oxford, United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 130 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Santa Monica, California, United States; Providence, Rhode Island, United States; Houston, Texas, United States; Beijing, China; Chengdu, China; Shanghai, China and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.