AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

Part of paid clinical trials in Orange, California.

Sponsor
AstraZeneca
Study ID
NCT06219941
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • AZD0901 — DRUG
    Antibody-drug conjugate/Biologic
  • 5-Fluorouracil — DRUG
    Chemotherapy agents
  • Leucovorin — DRUG
    Chemotherapy agents
  • l-leucovorin — DRUG
    Chemotherapy agents
  • Irinotecan — DRUG
    Chemotherapy agents
  • Nanoliposomal Irinotecan — DRUG
    Chemotherapy agents
  • Gemcitabine — DRUG
    Chemotherapy agents

Study Details

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 metastatic solid tumours expressing CLDN18.2.

Key Dates

Start date
Dec 13, 2023
Status verified
Feb 2026
Primary completion
Aug 11, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sub Study 1 - AZD0901 MONOTHERAPY
    Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.
  • Experimental: Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMA
    Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents
  • Experimental: Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCER
    Substudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR.

Primary Outcome Measure

Incidence of adverse events (AEs), serious AEs (SAEs). Changes from baseline in clinical laboratory parameters, vital signs, ECGs and physical examination. Rate of AEs leading to discontinuation of AZD0901, Occurrence of DLTs. [ Time Frame: 30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation. ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Research SiteOrangeCalifornia92868-
Research SitePalo AltoCalifornia94304-
Research SiteSanta RosaCalifornia95403-
Research SiteLouisvilleKentucky40202-
Research SiteCommackNew York11725-
Research SiteProvidenceRhode Island02903-
Research SiteHoustonTexas77030-

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