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 metast0tic solid tumours expressing CLDN18.2.

Hibi Kazushige0 个研究点目标入组 186 人开始时间: 2024年1月16日最近更新: 2024年5月27日

适应症

试验速览

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•Master Inclusion Criteria applicable to both sub sutudies:
•- Participant must be 18 years or more 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.
•- Predicted life expectancy of 12 weeks or more.
•- Adequate organ and bone marrow function as defined by protocol.
•- Body weight > 35kg.
•- Participants are willing to comply with contraception requirements.
•Sub study 1 Specific
•- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
•- Advanced or metastatic GC/GEJC.
•- Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.

•Master Exclusion Criteria applicable to both sub sutudies:
•- Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding on 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.
•- Peripheral neuropathy Grade 2 or more at screening.
•- History of another primary malignancy.
•- Prior exposure to any MMAE-based ADC.
•- Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.
•Sub Study 1 Specific
•- Participants with HAR2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC.
•- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
•- The use of concomitant medications known to prolong the QT/QTc interval.

发起方

Hibi Kazushige