RECRUITING

Study for AZD4360 in Participants With Advanced Solid Tumours

Description

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 Overview

Study Details

Study overview

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.

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

Study for AZD4360 in Participants With Advanced Solid Tumours

Condition
Gastric Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Research Site, Los Angeles, California, United States, 90095

Providence

Research Site, Providence, Rhode Island, United States, 02906

Houston

Research Site, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.
  • 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.

Ages Eligible for Study

18 Years to 130 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2027-11-17