First in Human Study to Evaluate AZD9793 in Participants With Advanced or Metastatic Solid Tumours

Part of paid clinical trials in La Jolla, California.

Sponsor
AstraZeneca
Study ID
NCT06795022
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • AZD9793 Intravenous (IV) monotherapy — DRUG
    T cell-engaging antibody that targets GPC3 on tumour cells
  • AZD9793 Subcutaneous (SC) monotherapy — DRUG
    T cell-engaging antibody that targets GPC3 on tumour cells

Study Details

This research is designed to determine if experimental treatment with AZD9793, a T cell-engaging antibody that targets GPC3, is safe, tolerable and has anti-cancer activity in patients with advanced or metastatic solid tumours which are GPC3+.

Key Dates

Start date
Mar 27, 2025
Status verified
Mar 2026
Primary completion
Feb 25, 2028
Completion
Jul 25, 2028

Study Design

Enrollment
304 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1: AZD9793 Intravenous (IV) monotherapy Part A
    Module 1: AZD9793 Intravenous (IV) monotherapy Part A: Dose Escalation
  • Experimental: Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A
    Module 2: AZD9793 Subcutaneous (SC) monotherapy Part A: Dose Escalation
  • Experimental: Module 1: AZD9793 Intravenous (IV) monotherapy Part B
    Module 1: AZD9793 Intravenous (IV) monotherapy Part B: Dose Expansion
  • Experimental: Module 2: AZD9793 Subcutaneous (SC) monotherapy Part B
    Module 2: AZD9793 Subcutaneous (SC) monotherapy Part B: Dose Expansion

Primary Outcome Measure

The number of patients with adverse events [ Time Frame: From first dose of study drug up to 30 days post last dose and prior to start of subsequent anticancer therapy ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92093-
Research SiteLos AngelesCalifornia90089-
Research SiteBaltimoreMaryland21201-
Research SiteSt LouisMissouri63108-
Research SiteHackensackNew Jersey07601-
Research SiteHoustonTexas77030-

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