OncoMatch/Clinical Trials/NCT06219941
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Is NCT06219941 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for gastric cancer.
Treatment: AZD0901 · 5-Fluorouracil · Leucovorin · l-leucovorin · Irinotecan · Nanoliposomal Irinotecan · Gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Cholangiocarcinoma
Pancreatic Cancer
Biomarker criteria
Required: CLDN18 overexpression (positive)
Participants who are CLDN18.2 positive
Excluded: HER2 (ERBB2) overexpression
Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC unless they have failed/not tolerated/or are not eligible for standard anti-HER2 therapy, where available
Disease stage
Required: Stage IV
Advanced or metastatic...unresectable advanced, or metastatic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received:
Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease
Cannot have received: MMAE-based antibody-drug conjugate
Prior exposure to any MMAE-based ADC
Cannot have received: CLDN18.2 targeted agent
Exception: except anti-CLDN18.2 monoclonal antibody
Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody
Lab requirements
Blood counts
Adequate organ and bone marrow function as defined by protocol
Kidney function
Adequate organ and bone marrow function as defined by protocol
Liver function
Adequate organ and bone marrow function as defined by protocol
Adequate organ and bone marrow function as defined by protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Orange, California
- Research Site · Palo Alto, California
- Research Site · Santa Rosa, California
- Research Site · Louisville, Kentucky
- Research Site · Commack, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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