AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
NCT ID: NCT06219941
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
190 participants
INTERVENTIONAL
2023-12-13
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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Sub Study 1 - AZD0901 MONOTHERAPY
Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.
AZD0901
Antibody-drug conjugate/Biologic
Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMA
Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents
AZD0901
Antibody-drug conjugate/Biologic
5-Fluorouracil
Chemotherapy agents
Leucovorin
Chemotherapy agents
l-leucovorin
Chemotherapy agents
Irinotecan
Chemotherapy agents
Nanoliposomal Irinotecan
Chemotherapy agents
Gemcitabine
Chemotherapy agents
Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCER
Substudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR.
AZD0901
Antibody-drug conjugate/Biologic
Interventions
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AZD0901
Antibody-drug conjugate/Biologic
5-Fluorouracil
Chemotherapy agents
Leucovorin
Chemotherapy agents
l-leucovorin
Chemotherapy agents
Irinotecan
Chemotherapy agents
Nanoliposomal Irinotecan
Chemotherapy agents
Gemcitabine
Chemotherapy agents
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
• Clinically significant biliary obstruction that has not resolved before enrollment.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Orange, California, United States
Research Site
Palo Alto, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Louisville, Kentucky, United States
Research Site
Commack, New York, United States
Research Site
Providence, Rhode Island, United States
Research Site
Houston, Texas, United States
Research Site
Melbourne, , Australia
Research Site
Murdoch, , Australia
Research Site
Randwick, , Australia
Research Site
Kingston, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Chengdu, , China
Research Site
Tbilisi, , Georgia
Research Site
Chūōku, , Japan
Research Site
Kashiwa, , Japan
Research Site
Kitaadachi-gun, , Japan
Research Site
Kōtoku, , Japan
Research Site
Nagoya, , Japan
Research Site
Osakasayama-shi, , Japan
Research Site
George Town, , Malaysia
Research Site
Johor Bahru, , Malaysia
Research Site
Kuala Lumpur, , Malaysia
Research Site
Kuala Selangor, , Malaysia
Research Site
Kuching, , Malaysia
Research Site
Chisinau, , Moldova
Research Site
Krakow, , Poland
Research Site
Warsaw, , Poland
Research Site
Bukit Merah, , Singapore
Research Site
Singapore, , Singapore
Research Site
Singapore, , Singapore
Research Site
Singapore, , Singapore
Research Site
Gyeonggi-do, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Glasgow, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Oxford, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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D9800C00001
Identifier Type: -
Identifier Source: org_study_id
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