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New targeted drug shows promise for hard-to-treat stomach and pancreatic cancers

NCT ID NCT06219941

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study tests a new drug called AZD0901, alone or with other cancer treatments, in people with advanced solid tumors that have a specific protein called CLDN18.2. The goal is to see if the drug is safe and can shrink tumors. About 224 adults with stomach, pancreatic, or bile duct cancers that have not responded to standard therapy will participate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 226 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bile duct adenocarcinoma biliary tract cancer Biliary Tract Neoplasms gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal cancer gastroesophageal junction adenocarcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer Gastric cancer Gastroesophageal junction cancer Pancreatic ductal adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    46 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Orange, California, 92868, United States

  • Research Site

    RECRUITING

    Palo Alto, California, 94304, United States

  • Research Site

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Research Site

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Research Site

    RECRUITING

    Commack, New York, 11725, United States

  • Research Site

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    Melbourne, 3000, Australia

  • Research Site

    RECRUITING

    Murdoch, WA6150, Australia

  • Research Site

    RECRUITING

    Randwick, 2031, Australia

  • Research Site

    WITHDRAWN

    Kingston, Ontario, K7L 2V7, Canada

  • Research Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H3G 1A4, Canada

  • Research Site

    RECRUITING

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Research Site

    NOT_YET_RECRUITING

    Changsha, 410013, China

  • Research Site

    NOT_YET_RECRUITING

    Chengdu, 610041, China

  • Research Site

    RECRUITING

    Tbilisi, 0112, Georgia

  • Research Site

    RECRUITING

    Chūōku, 104-0045, Japan

  • Research Site

    RECRUITING

    Kashiwa, 227-8577, Japan

  • Research Site

    RECRUITING

    Kitaadachi-gun, 362-0806, Japan

  • Research Site

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Research Site

    RECRUITING

    Nagoya, 464-8681, Japan

  • Research Site

    RECRUITING

    Osakasayama-shi, 589-8511, Japan

  • Research Site

    RECRUITING

    George Town, 10450, Malaysia

  • Research Site

    COMPLETED

    Johor Bahru, 81100, Malaysia

  • Research Site

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    RECRUITING

    Kuala Selangor, 62250, Malaysia

  • Research Site

    RECRUITING

    Kuching, 93586, Malaysia

  • Research Site

    RECRUITING

    Chisinau, MD-2025, Moldova

  • Research Site

    RECRUITING

    Krakow, 31-501, Poland

  • Research Site

    RECRUITING

    Warsaw, 02-034, Poland

  • Research Site

    RECRUITING

    Bukit Merah, 169610, Singapore

  • Research Site

    RECRUITING

    Singapore, 119074, Singapore

  • Research Site

    RECRUITING

    Singapore, 308433, Singapore

  • Research Site

    RECRUITING

    Singapore, 329563, Singapore

  • Research Site

    RECRUITING

    Gyeonggi-do, 13620, South Korea

  • Research Site

    RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    RECRUITING

    Seoul, 05505, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Barcelona, 08035, Spain

  • Research Site

    RECRUITING

    Madrid, 28007, Spain

  • Research Site

    RECRUITING

    Madrid, 28040, Spain

  • Research Site

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Research Site

    RECRUITING

    Taichung, 404, Taiwan

  • Research Site

    RECRUITING

    Tainan, 70403, Taiwan

  • Research Site

    RECRUITING

    Taipei, 11217, Taiwan

  • Research Site

    RECRUITING

    Taoyuan, 00333, Taiwan

  • Research Site

    WITHDRAWN

    Glasgow, G12 0YN, United Kingdom

  • Research Site

    WITHDRAWN

    Leeds, LS9 7TF, United Kingdom

  • Research Site

    WITHDRAWN

    London, NW3 2QG, United Kingdom

  • Research Site

    WITHDRAWN

    Oxford, OX3 7LE, United Kingdom

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