Comparing 3 approaches for gastric cancer
Official title: AZD0901 in Participants With Advanced Solid Tumours 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
- 3 groups
- Sites in Kingston, Toronto and 2 more cities
- Recruiting
Interventions (7)
- Medication
AZD0901
Antibody-drug conjugate/Biologic
- Medication
5-Fluorouracil
Chemotherapy agents
- Medication
Leucovorin
Chemotherapy agents
- Medication
l-leucovorin
Chemotherapy agents
- Medication
Irinotecan
Chemotherapy agents
- Medication
Nanoliposomal Irinotecan
Chemotherapy agents
- Medication
Gemcitabine
Chemotherapy agents
Canadian Sites (4)
3 of 4 recruiting
- Recruiting
Research Site
Toronto, Ontario
- Recruiting
Research Site
Montreal, Quebec
- Recruiting
Research Site
Sherbrooke, Quebec
- Withdrawn
Research Site
Kingston, Ontario
Eligibility Criteria
See who this study is looking for50 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +applicable to all sub studies:
- +Participant must be ≥ 18 years or the legal age of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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.
- +Predicted life expectancy of ≥ 12 weeks.
- +Adequate organ and bone marrow function as defined by protocolProtocolThe detailed plan a study must follow.Read more →.
- +Body weight \> 35 kg.
- +Sub study 1 Specific Inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +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 CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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
- +ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.
- +Participants are willing to comply with contraception requirements.
- +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.
Exclusion
- −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.
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −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 criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −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 SoCStandard of careThe treatment normally given for a condition outside a study.Read more →.
- −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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and C receive AZD0901.
Registry label: A: Sub Study 1 - AZD0901 MONOTHERAPY · C: Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCER
Group B receives AZD0901, together with one or more of: 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan, Nanoliposomal Irinotecan and Gemcitabine.
Registry label: B: Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMA
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 226 people.
The study is currently expected to finish around June 2027.
The main measurement is taken over: 30 days post treatment completion. AEAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → Follow UpFollow-upContinued check-ins after the treatment part is finished.Read more → for 90 days post AZD0901 discontinuation.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence of adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs), serious AEs (SAEs). Changes from baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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 UpFollow-upContinued check-ins after the treatment part is finished.Read more → for 90 days post AZD0901 discontinuation.
Objective Response Rate (ORR) — measured over From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06219941 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AZD0901Drug
Antibody-drug conjugate/Biologic
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About 5-FluorouracilDrug
Chemotherapy agents
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LeucovorinDrug
Chemotherapy agents
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About l-leucovorinDrug
Chemotherapy agents
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About IrinotecanDrug
Chemotherapy agents
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Nanoliposomal IrinotecanDrug
Chemotherapy agents
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GemcitabineDrug
Chemotherapy agents
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 30 days post treatment completion. AEAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → Follow UpFollow-upContinued check-ins after the treatment part is finished.Read more → for 90 days post AZD0901 discontinuation..
The study as a whole is currently expected to finish around 2027-06-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 226 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Kingston, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Sherbrooke, Quebec, Canada; Commack, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (1)
Research Site
Commack, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.