Study for AZD4360 in Participants With Advanced Solid Tumours

Part of paid clinical trials in Santa Monica, California.

Sponsor
AstraZeneca
Study ID
NCT06921928
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD4360 — DRUG
    Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)

Study Details

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.

Key Dates

Start date
Apr 29, 2025
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Dec 16, 2027

Study Design

Enrollment
117 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD4360 Monotherapy
    AZD4360 Monotherapy

Primary Outcome Measure

Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360 [ Time Frame: Through study completion, up to approximately 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteSanta MonicaCalifornia90404-
Research SiteProvidenceRhode Island02903-
Research SiteHoustonTexas77030-

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By specialty
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By research site
Research Site· Santa Monica, CAResearch Site· Providence, RIResearch Site· Houston, TX

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