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
- Tbilisi, GeorgiaSee the site
- Phase
- Phase 2
Where in Georgia
- TbilisiTbilisi, GeorgiaTaking 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?
Trial 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.