Study for AZD4360 in Participants With Advanced Solid Tumours

Korábbi kezelés

• 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.
• History of another primary malignancy within 2 years prior to screening.

Más betegség

• History of non-infectious interstitial lung disease/pneumonitis.
• Participant has cardiac abnormalities, as defined by protocol.
• Known serologic status reflecting active hepatitis B or hepatitis C.
• Known HIV infection that is not well controlled.
• Active tuberculosis infection.

Egyéb

• 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.
• Participants with clinically significant ascites that require drainage.
• Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
• With spinal cord compression or with high risk of paralysis.

• Participant must be ≥ 18 at the time of signing the ICF.
• 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.
• Minimum life expectancy of 12 weeks in the opinion of the Investigator.
  • 4 Adequate organ and marrow function, as defined by protocol.
• Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.
• 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.
• Participants must have received at least one prior line of systemic therapy in the advanced/metastatic disease.
• At least one measurable lesion according to RECIST v1.1.