AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

anti-Claudin18.2 ADC AZD0901. An antibody-drug conjugate (ADC) composed of a monoclonal antibody directed against the tumor-associated antigen (TAA) Claudin18.2 (CLDN18.2; A2 isoform of claudin-18) conjugated via a cleavable linker, to the microtubule-disrupting cytotoxic agent monomethyl auristatin E (MMAE), with potential antineoplastic activity. Upon administration, anti-CLDN18.2 ADC AZD0901 specifically targets and binds to CLDN18.2 expressed on tumor cells. Upon internalization and the release of MMAE, MMAE targets and binds to tubulin, and inhibits microtubule polymerization. This results in G2/M phase cell cycle arrest and apoptosis in CLDN18.2-expressing tumor cells. CLDN18.2, a tight junction protein and stomach-specific isoform of claudin-18, is expressed on a variety of tumor cells. Its expression in healthy tissues is strictly confined to short-lived differentiated epithelial cells of the gastric mucosa. NCI Drug Dictionary

Treatments listed in the registry

• 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

Randomized · Parallel · masking: None

Main goals

• Incidence of adverse events (AEs), serious AEs (SAEs). Changes from baseline in clinical laboratory parameters, vital signs, ECGs and physical examination. Rate of AEs leading to discontinuation of AZD0901, Occurrence of DLTs. (30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.)
• Objective Response Rate (ORR). (From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).)

Other goals

• Overall Survival (OS)
• Progression Free Survival (PFS)
• Duration of Response (DoR)
• Disease control rate (DCR)
• Percentage change in tumor size
• Serum concentration of AZD0901 (total ADC), total antibody (conjugated and unconjugated) and total unconjugated MMAE
• Serum PK parameters of AZD0901, total antibody (conjugated and unconjugated) and MMAE including but not limited to AUC, Cmax, tmax, clearance and half-life, as data allow.
• Clinical activity by baseline and/or on-treatment tissue-based biomarkers including, but not limited to, gene expression, mutation profiles, DNA damage, protein expression, immune response and/or mechanisms of resistance.
• ADA status will be determined along with prevalence and incidence of anti-drug antibodies to AZD0901, and titer established.

Planned enrollment: 226 (estimated).

• Research Site, Orange, California
• Research Site, Palo Alto, California
• Research Site, Santa Rosa, California
• Research Site, Louisville, Kentucky
• Research Site, Commack, New York
• Research Site, Providence, Rhode Island
• Research Site, Houston, Texas

37 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06219941
• NCI Drug Dictionary: C180413

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 29, 2026. Public record; not medical advice.