Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
AstraZeneca
Study ID
NCT06005493
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD5863 — DRUG
    T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells

Study Details

This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.

Key Dates

Start date
Jul 11, 2023
Status verified
Feb 2026
Primary completion
Jul 16, 2027
Completion
Jul 16, 2027

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1: AZD5863 Monotherapy Intravenous (IV)
    Module 1: AZD5863 Intravenous (IV) Monotherapy
  • Experimental: Module 2: AZD5863 Monotherapy Subcutaneous (SC)
    Module 2: AZD5863 Subcutaneous (SC) Monotherapy

Primary Outcome Measure

The number of patients with adverse events [ Time Frame: From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteJacksonvilleFlorida32224-
Research SiteRochesterMinnesota55905-
Research SiteNew YorkNew York10065-

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