Study for AZD4360 in Participants With Advanced Solid Tumours

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

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.

Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.

Trial design

Treatments tested in this trial

  • AZD4360

Treatment groups

117 Participants
are divided into 1 treatment group

Sponsors and collaborators