Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

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.

Official Title

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

Keywords

Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumours, AZD4360, Claudin 18.2, Adenocarcinoma, Stomach Neoplasms, Biliary Tract Neoplasms, AZD4360 Monotherapy

Eligibility

You can join if…

Open to people ages 18-130

  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.

  1. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.
  2. 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.
  3. Participants must have received at least one prior line of systemic therapy in the advanced/metastatic disease.
  4. At least one measurable lesion according to RECIST v1.1.

You CAN'T join if...

  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.

Locations

  • Research Site
    Los Angeles California 90095 United States
  • Research Site
    Houston Texas 77030 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT06921928
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 117 study participants
Last Updated