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Looking for participantsPhase2

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

Sponsor: AstraZeneca

NCT ID: NCT06219941

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD0901 (drug), 5-Fluorouracil (drug), Leucovorin (drug), l-leucovorin (drug)
How long the study runs
Study runs about 42 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
226
Started
2023-12-13
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for gastric cancer
  • • Phase2 - 226 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with gastric cancer

Where?

  • • Glasgow - Research Site
  • • Leeds - Research Site
  • • London - Research Site
  • • Oxford - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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 .

More detail

This open-label, multi-centre study consists of individual sub studies, each evaluating the safety and tolerability of AZD0901. Sub study 1 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic gastric esophageal cancer expressing CLDN18.2. Participants will receive AZD0901 monotherapy via intravenous (IV) infusion and will be randomised in to one of 2 arms. Sub study 2 will consist of two parts, a safety run-in and a dose expansion part to investigate the safety and efficacy of AZD0901 in combination with different chemotherapy agents in participants with pancreatic cancer. Substudy 3 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic Biliary tract cancer.

Gastric CancerGastroesophageal Junction CancerBiliary Tract CancerPancreatic Ductal Adenocarcinoma

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2and positive

Treatment history

Treatments you must have had:

  • ✓ and maximum 2 pri
  • ✓ drainage

What the study is looking for

  • ✓confirmed by a biopsy adenocarcinoma of the stomach or gastroesophageal junction.
  • ✓Advanced or that has spread GC/GEJC.
  • ✓Maximum 2 prior lines of systemic treatment for unresectable or that has spread disease.
  • ✓Sub study 2 Specific Inclusion criteria:
  • ✓Participants diagnosed with confirmed by a biopsy that has spread or advanced PDAC.

Who cannot take part

  • ✗Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
  • ✗The use of concomitant medications known to prolong the QT/QTc interval.
  • ✗Sub study 2 Specific Exclusion criteria:
  • ✗Known DPD enzyme deficiency based on local testing where testing is SoC.
  • ✗Use of strong inhibitor or inducer of UGT1A1.
See the full criteria
The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria. Master Inclusion Criteria applicable to all sub studies: * Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF. * Participants who are CLDN18.2 positive. * Must have at least one measurable lesion according to RECIST v1.1. * ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing. * Predicted life expectancy of ≥ 12 weeks. * Adequate organ and bone marrow function as defined by protocol. * Body weight \> 35 kg. * Participants are willing to comply with contraception requirements. Sub study 1 Specific Inclusion criteria: * Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction. * Advanced or metastatic GC/GEJC. * Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease. Sub study 2 Specific Inclusion criteria: * Participants diagnosed with histologically confirmed metastatic or advanced PDAC. * Availability of an archival sample or a fresh tumour biopsy taken at screening. * No prior treatments for unresectable or metastatic disease. Prior neoadjuvant/adjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose. Sub study 3 Specific Inclusion criteria * Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (NOTE: Ampullary cancers are not eligible). * 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. Master Exclusion Criteria applicable to all sub studies: * Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy. * Participants with clinically significant ascites that require drainage. * A history of drug-induced non-infectious ILD/pneumonitis. * Central nervous system metastases or CNS pathology. * Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening. * History of another primary malignancy. * Prior exposure to any MMAE-based ADC. * Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody. Sub study 1 Specific Exclusion criteria: * 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. * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events. * The use of concomitant medications known to prolong the QT/QTc interval. Sub study 2 Specific Exclusion criteria: * Known DPD enzyme deficiency based on local testing where testing is SoC. * Use of strong inhibitor or inducer of UGT1A1. * Use of strong inhibitors or inducers of CYP3A4. * Known homozygous for the UGT1A1\*28 allele based on local testing where testing is SoC. Sub study 3 Specific Exclusion criteria • Clinically significant biliary obstruction that has not resolved before enrollment.

Where Is This Study? (4 UK sites)

Research Site

Glasgow G12 0YN, United Kingdom

WITHDRAWN

Research Site

Leeds LS9 7TF, United Kingdom

WITHDRAWN

Research Site

London NW3 2QG, United Kingdom

WITHDRAWN

Research Site

Oxford OX3 7LE, United Kingdom

WITHDRAWN

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09