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Clinical Trials in the UK / NCT06219941
Recruiting Phase 2

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

NCT06219941 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2023-12-13
Last updated
2026-07-29

Condition(s) studied

Gastric CancerGastroesophageal Junction CancerBiliary Tract CancerPancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

AZD09015-FluorouracilLeucovorinl-leucovorinIrinotecanNanoliposomal IrinotecanGemcitabine

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
Research Site Orange California Recruiting
Research Site Palo Alto California Recruiting
Research Site Santa Rosa California Recruiting
Research Site Louisville Kentucky Recruiting
Research Site Commack New York Recruiting
Research Site Providence Rhode Island Recruiting
Research Site Houston Texas Recruiting
Research Site Melbourne Australia Recruiting
Research Site Murdoch Australia Recruiting
Research Site Randwick Australia Recruiting
Research Site Kingston Ontario Withdrawn
Research Site Toronto Ontario Recruiting
Research Site Montreal Quebec Recruiting
Research Site Sherbrooke Quebec Recruiting
Research Site Changsha China Not Yet Recruiting
Research Site Chengdu China Not Yet Recruiting
Research Site Tbilisi Georgia Recruiting
Research Site Chūōku Japan Recruiting
Research Site Kashiwa Japan Recruiting
Research Site Kitaadachi-gun Japan Recruiting
Research Site Kōtoku Japan Recruiting
Research Site Nagoya Japan Recruiting
Research Site Osakasayama-shi Japan Recruiting
Research Site George Town Malaysia Recruiting
Research Site Johor Bahru Malaysia Completed
Research Site Kuala Lumpur Malaysia Recruiting
Research Site Kuala Selangor Malaysia Recruiting
Research Site Kuching Malaysia Recruiting
Research Site Chisinau Moldova Recruiting
Research Site Krakow Poland Recruiting
Research Site Warsaw Poland Recruiting
Research Site Bukit Merah Singapore Recruiting
Research Site Singapore Singapore Recruiting
Research Site Singapore Singapore Recruiting
Research Site Singapore Singapore Recruiting
Research Site Gyeonggi-do South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting

+ 12 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06219941 on ClinicalTrials.gov ↗ ← All trials in the UK