NCT06219941

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Cancer
• Biliary Tract Cancer
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	AZD0901	Antibody-drug conjugate/Biologic
DRUG	5-Fluorouracil	Chemotherapy agents
DRUG	Leucovorin	Chemotherapy agents
DRUG	l-leucovorin	Chemotherapy agents
DRUG	Irinotecan	Chemotherapy agents
DRUG	Nanoliposomal Irinotecan	Chemotherapy agents
DRUG	Gemcitabine	Chemotherapy agents

Timeline

• Start date: 2023-12-13
• Primary completion: 2026-08-11
• Completion: 2027-09-30
• First posted: 2024-01-23
• Last updated: 2026-02-12

Locations

52 sites across 14 countries: United States, Australia, Canada, China, Georgia, Japan, Malaysia, Moldova, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study