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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (4 UK sites)
Research Site
Glasgow G12 0YN, United Kingdom
Research Site
Leeds LS9 7TF, United Kingdom
Research Site
London NW3 2QG, United Kingdom
Research Site
Oxford OX3 7LE, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
