AZD4360 for Stomach Cancer

Recruiting at 7 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

Trial Summary

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.

What safety data exists for AZD4360 in humans?

There is no specific safety data available for AZD4360 in humans from the provided research articles. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comprehensive clinical pharmacology characterization of AZD4635 in healthy participants to support dosing considerations. [2023]

2. England pubmed.ncbi.nlm.nih.gov

ZD6126 inhibits orthotopic growth and peritoneal carcinomatosis in a mouse model of human gastric cancer. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Phase II trial of mitoxantrone in advanced gastric cancer. [2018]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Phase II study of diaziquone in untreated advanced gastric carcinoma. A Southwest Oncology Group Study. [2019]