The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.
Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.
Participants who are CLDN18.2 positive.
Must have at least one measurable lesion according to RECIST v1.1.
ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.
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.
Participants with clinically significant ascites that require drainage.
A history of drug-induced non-infectious ILD/pneumonitis.
Central nervous system metastases or CNS pathology.
AstraZeneca
Lead sponsor