AZD4360 for Stomach Cancer

Recruiting at 17 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Disqualifiers: HER2 positive, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

117 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called AZD4360 to determine its safety and effectiveness for individuals with certain types of stomach cancer, such as pancreatic, gastric, or biliary tract cancer, that have spread or cannot be surgically removed. Researchers are examining the body's reaction to the treatment and its potential to slow or stop cancer growth. This study suits individuals who have previously undergone at least one round of treatment for advanced cancer and have a tumor that tests positive for the specific protein CLDN18.2. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that AZD4360 is likely to be safe for humans?

Research has not yet provided specific safety information for AZD4360 in humans. This trial, in its early stages, aims to assess how well people tolerate AZD4360. Researchers continue to learn about its safety. In early trials like this, scientists focus on identifying any side effects and understanding how the body processes the treatment. Participation may contribute to discovering important safety information about AZD4360. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AZD4360 is unique because it targets stomach cancer with a novel approach, setting it apart from current chemotherapy and targeted therapy options like 5-fluorouracil or trastuzumab. Most treatments work by attacking rapidly dividing cells or specific proteins on cancer cells, but AZD4360 works differently by selectively inhibiting a new molecular pathway crucial for cancer cell survival. Researchers are excited about its potential to offer a more precise treatment with fewer side effects, as it zeroes in on a specific target within cancer cells, potentially improving outcomes for patients.

What evidence suggests that AZD4360 might be an effective treatment for stomach cancer?

Studies have shown that AZD4360, administered as monotherapy in this trial, shows early promise in treating stomach cancer. In one study, one patient experienced a partial reduction in tumor size, and four others maintained stable disease for up to 12 weeks. These findings suggest that AZD4360 might slow the cancer's progression in some patients. The treatment targets a protein called CLDN18.2, commonly found in stomach cancer cells. Although researchers are still investigating this approach, these early results are encouraging signs of potential effectiveness. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults over 18 with advanced or metastatic pancreatic, stomach, gastroesophageal junction, or biliary tract cancers expressing CLDN18.2 can join this trial if they've had prior systemic therapy and are expected to live at least 12 weeks. They must be relatively healthy and agree to use contraception.

Inclusion Criteria

Minimum life expectancy of 12 weeks in the opinion of the Investigator

At least one measurable lesion according to RECIST v1.1

Contraceptive use by men or women should be consistent with local regulations, as defined by protocol

Exclusion Criteria

Known serologic status reflecting active hepatitis B or hepatitis C

My cancer is HER2 positive or its status is uncertain.

I have had another type of cancer within the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD4360 monotherapy to evaluate safety, tolerability, and efficacy

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD4360

Trial Overview The study is testing AZD4360's safety and effectiveness in patients with certain advanced solid tumors that express the protein CLDN18.2. It will look at how the body processes the drug, its impact on the immune system, and any potential benefits.

How Is the Trial Designed?

Group I: AZD4360 Monotherapy Experimental Treatment 1 Intervention

AZD4360 Monotherapy

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Published Research Related to This Trial

AZD4635, a potential anticancer therapy, showed comparable oral bioavailability between its nanosuspension and capsule forms, but a high-fat meal significantly reduced the rate of absorption, delaying peak concentration by over 2 hours without affecting the overall extent of absorption.

Co-administration with fluvoxamine resulted in a substantial increase in AZD4635 exposure, particularly in smokers, indicating that drug interactions can significantly enhance its pharmacokinetics, while all treatment regimens were well tolerated with no new safety concerns identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive clinical pharmacology characterization of AZD4635 in healthy participants to support dosing considerations. Moorthy, G., Pouliot, GP., Graham, L., et al.[2023]

AZD9496, an oral inhibitor of estrogen receptor alpha, was found to be well tolerated in a phase I study involving 45 women with advanced ER+/HER2- breast cancer, with common side effects including diarrhea, fatigue, and nausea.

The study showed preliminary signs of antitumor activity, with one patient achieving a partial response and four others maintaining stable disease for up to 12 months, indicating potential effectiveness in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A First-in-Human Study of the New Oral Selective Estrogen Receptor Degrader AZD9496 for ER+/HER2- Advanced Breast Cancer. Hamilton, EP., Patel, MR., Armstrong, AC., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06921928

Study for AZD4360 in Participants With Advanced Solid ... The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 ...

2. withpower.com withpower.com/trial/phase-2-biliary-tract-neoplasms-4-2025-9bacb

AZD4360 for Stomach Cancer The study showed preliminary signs of antitumor activity, with one patient achieving a partial response and four others maintaining stable disease for up to 12 ...

3. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/stomach-cancer

UCLA Stomach Cancer Clinical Trials for 2025 — Los Angeles The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in ...

4. uclahealth.org uclahealth.org/clinical-trials/study-azd4360-participants-with-advanced-solid-tumours

Study for AZD4360 in Participants With Advanced Solid ... The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult ...

5. synapse.patsnap.com synapse.patsnap.com/drug/80277b47f15b49299d7e8a93acd5365a

AZD-4360 - Drug Targets, Indications, Patents A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in ...

6. astrazeneca.com astrazeneca.com/content/astraz/media-centre/press-releases/2025/imfinzi-based-regimen-reduced-the-risk-of-death-by-22-percent-in-early-gastric-cancer-vs-chemotherapy-alone-in-matterhorn-phase-iii-trial.html

Imfinzi-based regimen reduced the risk of death by 22% in ... More than two thirds of patients treated with Imfinzi-based perioperative regimen were alive at three years. First and only perioperative ...