Tests AZD0901 in advanced cancers that express Claudin 18.2
Tests AZD0901, alone or with other drugs, in adults with advanced solid tumours.
Plain-language title generated from the registry record
Registry title: AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Key facts
- Where
- Bukit Merah and Singapore, SingaporeSee the 2 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic stomach, gastroesophageal junction, pancreatic or biliary tract cancer whose tumour is CLDN18.2 positive.
- Age
- 18 years or older (or the legal age of consent)
- Sex
- All sexes can join.
- Disease stage
- Locally advanced that cannot be removed by surgery, or metastatic. Stomach or gastroesophageal junction adenocarcinoma, pancreatic ductal adenocarcinoma, or biliary tract adenocarcinoma. At least one measurable lesion (RECIST v1.1).
- Earlier treatment
- Stomach or gastroesophageal junction cancer: maximum 2 prior lines of systemic treatment. Pancreatic cancer: no prior treatment for unresectable or metastatic disease; earlier chemotherapy before or after surgery is allowed if the cancer progressed at least 6 months (183 days) after the last dose. Biliary tract cancer: progression on or after at least one prior regimen, maximum 2 prior lines. Cannot have had any MMAE-based ADC.
- Biomarker or test result
- The tumour must be CLDN18.2 positive.
Main reasons for not taking part
- Unstable or active peptic ulcer disease or digestive tract bleeding
- Clinically significant ascites that needs drainage
- History of drug-induced non-infectious ILD/pneumonitis
- Central nervous system metastases or CNS pathology
- History of another primary malignancy
Read by machine on 12 November 2026.
Where in Singapore
- Bukit MerahHospital not named in the registryTaking people
- SingaporeHospital not named in the registryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06219941EU 2023-508275-37-00
- Record updated
- 30 September 2026
- Original description
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 .Read full original descriptionShow less
A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)
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 .
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.