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Treatment with AZD0901 for advanced solid tumors expressing Claudin18.2

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)

Phase 2 Interventional AstraZeneca · NCT06219941

This study is testing a new treatment called AZD0901 for people with advanced solid tumors that have a specific protein, to see if it works better alone or with other chemotherapy drugs.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment224 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy
Locations52 sites (Orange, California and 51 other locations)
Trial IDNCT06219941 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and efficacy of AZD0901, both as a standalone treatment and in combination with other chemotherapy agents, for patients with advanced solid tumors that express the protein Claudin18.2. The study includes multiple sub-studies focusing on different types of cancers, including gastric, gastroesophageal junction, biliary tract, and pancreatic cancers. Participants will receive AZD0901 via intravenous infusion, and the study will assess various outcomes including pharmacokinetics and immunogenicity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors expressing Claudin18.2 and a life expectancy of at least 12 weeks.

Not a fit: Patients with tumors that do not express Claudin18.2 or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers expressing Claudin18.2.

How similar studies have performed: Other studies targeting Claudin18.2 have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Orange, California and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Gastric CancerGastroesophageal Junction CancerBiliary Tract CancerPancreatic Ductal AdenocarcinomaGastric cancerGastroesophageal junction cancerPancreatic Ductal adenocarcinomaPhase II
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.