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AZD0901 for Advanced Solid Tumors with Claudin18.2

This study is testing a new drug called AZD0901, alone or with chemotherapy, for people with advanced gastric (stomach), gastroesophageal junction (where the esophagus meets the stomach), biliary tract, or pancreatic cancers. Researchers want to see how safe AZD0901 is, how well people tolerate it, and if it helps shrink tumors. You might be able to join if you are 18 or older, have one of these cancers, and your tumor has a specific marker called CLDN18.2. The study will look at side effects and how many people's tumors shrink or disappear. The study plans to enroll 224 participants, but its current status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It involves different sub-studies, with some participants receiving AZD0901 alone and others receiving it with chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for side effects for 90 days after stopping AZD0901. Tumor response will be monitored for approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06219941

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~226 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:AZD09015-FluorouracilLeucovorinl-leucovorinIrinotecanNanoliposomal Irinotecan

At a glance

Recruiting sites
44 of 52 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.
+1 more outcome measured

Conditions

Gastric Cancer
Gastroesophageal Junction Cancer
Biliary Tract Cancer
Pancreatic Ductal Adenocarcinoma

Explore related trials

Gastric CarcinomaGastroesophageal Junction AdenocarcinomaMalignant neoplasm of biliary tractPancreatic Ductal AdenocarcinomaSolid NeoplasmClaudin-18 Isoform A2

Where it's being run

52 sites across 19 states
Japan6
Malaysia5
South Korea5
Taiwan5
Singapore4
United Kingdom4
California3
Australia3

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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.
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.

Exclusion

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.
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.
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.

What this trial measures

  • 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.

    To investigate the safety and tolerability, of AZD0901 monotherapy or in combination with anti-cancer agents in particpants with advanced or metastatic solid tumours expressing CLDN18.2.

  • 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).

    Proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR) as determined by the Investigator at local site as per RECIST v1.1.