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Recruiting Phase 1/2 NCT06921928

Study for AZD4360 in Participants With Advanced Solid Tumours

Phase 1/2 – combined early trial
Conditions: Gastric Cancer Gastroesophageal Junction Cancer Biliary Tract Cancer Pancreatic Ductal Adenocarcinoma

Sponsor: AstraZeneca

trial.available_in: БГ
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.
Who can participate
Inclusion 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. 4 Adequate organ and marrow function, as defined by protocol. 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. Exclusion Criteria: 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.
Interventions
AZD4360
DRUG
Locations 18
China (4)
Research Site
Beijing
Research Site
Chengdu
Research Site
Shanghai
Research Site
Wuhan
Germany (3)
Research Site
Berlin
NOT_YET_RECRUITING
Research Site
Dresden
Research Site
Frankfurt
Japan (4)
Research Site
Chūōku
Research Site
Kashiwa
Research Site
Kōtoku
Research Site
Sendai
NOT_YET_RECRUITING
United Kingdom (4)
Research Site
Glasgow
NOT_YET_RECRUITING
Research Site
Leeds
NOT_YET_RECRUITING
Research Site
London
Research Site
Oxford
NOT_YET_RECRUITING
United States (3)
Research Site
Houston , Texas
Research Site
Providence , Rhode Island
Research Site
Santa Monica , California
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
130 Years
Healthy volunteers
No
Start date
29.04.2025
Completion date
16.12.2027
Registry ID
NCT06921928
Source
clinicaltrials.gov
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