AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

NCT06219941 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2026-02-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

AZD0901

Antibody-drug conjugate/Biologic

DRUG

5-Fluorouracil

Chemotherapy agents

DRUG

Leucovorin

Chemotherapy agents

DRUG

l-leucovorin

Chemotherapy agents

DRUG

Irinotecan

Chemotherapy agents

DRUG

Nanoliposomal Irinotecan

Chemotherapy agents

DRUG

Gemcitabine

Chemotherapy agents

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-13
Primary Completion
2026-08-11
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Georgia
  • Japan
  • Malaysia
  • Moldova
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06219941 on ClinicalTrials.gov