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AzTrials

Gastric CancerPhase 2NCT06219941

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

A Phase 2 study testing AZD0901, 5-Fluorouracil and Leucovorin in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by AstraZeneca at 52 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AZD0901, 5-Fluorouracil and Leucovorin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
52 sitesin 14 countries
Study dates
13 Dec 2023to 28 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

52 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

52 sites in 14 countries

United States7 sites, 7 recruiting

  • Research Site

    Commack, New York, 11725

    Recruiting

  • Research Site

    Houston, Texas, 77030

    Recruiting

  • Research Site

    Louisville, Kentucky, 40202

    Recruiting

  • Research Site

    Orange, California, 92868

    Recruiting

  • Research Site

    Palo Alto, California, 94304

    Recruiting

  • Research Site

    Providence, Rhode Island, 02903

    Recruiting

  • Research Site

    Santa Rosa, California, 95403

    Recruiting

Other trials in United States

Japan6 sites, 6 recruiting

  • Research Site

    Chūōku, 104-0045

    Recruiting

  • Research Site

    Kashiwa, 227-8577

    Recruiting

  • Research Site

    Kitaadachi-gun, 362-0806

    Recruiting

  • Research Site

    Kōtoku, 135-8550

    Recruiting

  • Research Site

    Nagoya, 464-8681

    Recruiting

  • Research Site

    Osakasayama-shi, 589-8511

    Recruiting

Other trials in Japan

Malaysia5 sites, 4 recruiting

  • Research Site

    George Town, 10450

    Recruiting

  • Research Site

    Johor Bahru, 81100

    Completed

  • Research Site

    Kuala Lumpur, 59100

    Recruiting

  • Research Site

    Kuala Selangor, 62250

    Recruiting

  • Research Site

    Kuching, 93586

    Recruiting

Other trials in Malaysia

South Korea5 sites, 5 recruiting

  • Research Site

    Gyeonggi-do, 13620

    Recruiting

  • Research Site

    Seoul, 03080

    Recruiting

  • Research Site

    Seoul, 03722

    Recruiting

  • Research Site

    Seoul, 05505

    Recruiting

  • Research Site

    Seoul, 06351

    Recruiting

Other trials in South Korea

Taiwan5 sites, 5 recruiting

  • Research Site

    Kaohsiung City, 80756

    Recruiting

  • Research Site

    Taichung, 404

    Recruiting

  • Research Site

    Tainan, 70403

    Recruiting

  • Research Site

    Taipei, 11217

    Recruiting

  • Research Site

    Taoyuan, 00333

    Recruiting

Other trials in Taiwan

Canada4 sites, 3 recruiting

  • Research Site

    Kingston, Ontario, K7L 2V7

    Withdrawn

  • Research Site

    Montreal, Quebec, H3G 1A4

    Recruiting

  • Research Site

    Sherbrooke, Quebec, J1G 2E8

    Recruiting

  • Research Site

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

Singapore4 sites, 4 recruiting

  • Research Site

    Bukit Merah, 169610

    Recruiting

  • Research Site

    Singapore, 119074

    Recruiting

  • Research Site

    Singapore, 308433

    Recruiting

  • Research Site

    Singapore, 329563

    Recruiting

Other trials in Singapore

United Kingdom4 sites

  • Research Site

    Glasgow, G12 0YN

    Withdrawn

  • Research Site

    Leeds, LS9 7TF

    Withdrawn

  • Research Site

    London, NW3 2QG

    Withdrawn

  • Research Site

    Oxford, OX3 7LE

    Withdrawn

Other trials in United Kingdom

Australia3 sites, 3 recruiting

  • Research Site

    Melbourne, 3000

    Recruiting

  • Research Site

    Murdoch, WA6150

    Recruiting

  • Research Site

    Randwick, 2031

    Recruiting

Other trials in Australia

Spain3 sites, 3 recruiting

  • Research Site

    Barcelona, 08035

    Recruiting

  • Research Site

    Madrid, 28007

    Recruiting

  • Research Site

    Madrid, 28040

    Recruiting

Other trials in Spain

China2 sites, 2 recruiting

  • Research Site

    Changsha, 410013

    Not yet recruiting

  • Research Site

    Chengdu, 610041

    Not yet recruiting

Other trials in China

Poland2 sites, 2 recruiting

  • Research Site

    Krakow, 31-501

    Recruiting

  • Research Site

    Warsaw, 02-034

    Recruiting

Other trials in Poland

Georgia1 site, 1 recruiting

  • Research Site

    Tbilisi, 0112

    Recruiting

Other trials in Georgia

Moldova1 site, 1 recruiting

  • Research Site

    Chisinau, MD-2025

    Recruiting

Other trials in Moldova

About this study

Official title: 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 .

Read the detailed description

This open-label, multi-centre study consists of individual sub studies, each evaluating the safety and tolerability of AZD0901.

Sub study 1 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic gastric esophageal cancer expressing CLDN18.2. Participants will receive AZD0901 monotherapy via intravenous (IV) infusion and will be randomised in to one of 2 arms.

Sub study 2 will consist of two parts, a safety run-in and a dose expansion part to investigate the safety and efficacy of AZD0901 in combination with different chemotherapy agents in participants with pancreatic cancer. Substudy 3 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic Biliary tract cancer.

Being tested
AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan
Keywords
Gastric cancer, Gastroesophageal junction cancer, Pancreatic Ductal adenocarcinoma, Biliary Tract Cancer, Phase II, Claudin 18.2, AZD0901
Medical subject headings
Stomach Neoplasms, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD0901Drug

    Also called CMG901

    Antibody-drug conjugate/Biologic

  • 5-FluorouracilDrug

    Also called 5-FU

    Chemotherapy agents

  • LeucovorinDrug

    Also called LV

    Chemotherapy agents

  • l-leucovorinDrug

    Also called I-LV

    Chemotherapy agents

  • IrinotecanDrug

    Also called Camptosar

    Chemotherapy agents

  • Nanoliposomal IrinotecanDrug

    Also called ONIVYDE

    Chemotherapy agents

  • GemcitabineDrug

    Also called Gemzar

    Chemotherapy agents

Study groups in NCT06219941
Study groupRoleWhat they receive
Sub Study 1 - AZD0901 MONOTHERAPYExperimentalSub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.
Receives: Drug: AZD0901
Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMAExperimentalSubstudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents
Receives: Drug: AZD0901; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: l-leucovorin; Drug: Irinotecan; Drug: Nanoliposomal Irinotecan; Drug: Gemcitabine
Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCERExperimentalSubstudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR.
Receives: Drug: AZD0901

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: 30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.

  2. Objective Response Rate (ORR).

    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.

    Measured: From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

Secondary outcomes (9)

  1. Overall Survival (OS)

    The analysis will include all dosed/randomised participants as assigned/randomised. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy.

    Measured: From date of first dose/randomisation until the date of death due to any cause (approximately 2 years).

  2. Progression Free Survival (PFS)

    Progression-free survival is defined as the time date of randomisation or enrollment until progression per RECIST v1.1 as assessed by the Investigator at local site, or death due to any cause, regardless of whether the participant withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression.

    Measured: From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 2 years).

  3. Duration of Response (DoR)

    The time from the date of first documented confirmed response until date of first documented progression per RECIST v1.1 or death due to any cause.

    Measured: From the date of first documented confirmed response until date of documented progression (approximately 2 years).

  4. Disease control rate (DCR)

    The percentage of participants who have a confirmed CR or PR or who have SD per RECIST v1.1 as assessed by the Investigator at local site and derived from the raw tumour data up to 11 weeks after date of first dose/randomisation.

    Measured: Up to 11 weeks post date of first dose/randomisation

  5. Percentage change in tumor size

    The best percentage change from baseline in tumor size is the largest decrease (or smallest increase) from baseline for a participant, using RECIST v1.1 assessments.

    Measured: From start through to study completion.

  6. Serum concentration of AZD0901 (total ADC), total antibody (conjugated and unconjugated) and total unconjugated MMAE

    To characterise the PK of AZD0901 monotherapy or in combination with anti cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2.

    Measured: From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.

  7. 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.

    To characterise the PK of AZD0901 monotherapy or in combination with anti cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2.

    Measured: From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.

  8. 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.

    To investigate baseline and/or on-treatment tissue-based RNA, DNA, and/or proteins, and association with clinical activity of AZD0901 (substudy 1).

    Measured: From date of first dose of AZD0901 up to 7 weeks.

  9. ADA status will be determined along with prevalence and incidence of anti-drug antibodies to AZD0901, and titer established.

    To determine the immunogenicity of AZD0901 monotherapy or in combination with anti-cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2.

    Measured: From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start13 Dec 2023
  3. Primary completion17 Nov 2026 (estimated)
  4. Study completion28 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is an open-label, multi-centre study of AZD0901 administered via IV, either as monotherapy or in combination with other anti-cancer agents in participants with advanced solid malignancies expressing CLDN18.2. The substudy design allows for a targeted approach to the different tumour types as monotherapy or in combination with other anti-cancer agents. These substudies include: Substudy 1: AZD0901 monotherapy in gastric and gastric esophageal junction cancer patients Substudy 2: AZD0901 in combination with anti-cancer agents in pancreatic cancer patients. Substudy 3: AZD0901 monotherapy in biliary Tract Cancer.
Masking
None (open label)
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06219941
Sponsor's protocol ID
D9800C00001
Status last verified
Sep 2026
First submitted
21 Nov 2023
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD0901, 5-Fluorouracil and Leucovorin in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by AstraZeneca at 52 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Japan, Malaysia, South Korea, Taiwan and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06219941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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