RecruitingPhase 2NCT06219941

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)

Sponsor

AstraZeneca

Enrollment

224 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Gastroesophageal-junction Cancer Biliary Tract Cancer Pancreatic Ductal Adenocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing AZD0901, a new experimental antibody-drug that targets a protein called Claudin18.2, which is found on certain stomach, pancreatic, and bile duct tumors. The drug is being tested in patients with advanced cancers that express this protein and have already received prior treatments. **You may be eligible if...** - You are 18 or older with advanced or metastatic gastric/stomach cancer, pancreatic cancer, or bile duct cancer - Your tumor tests positive for Claudin18.2 - You have at least one measurable tumor and are in good overall health (ECOG 0–1) - You weigh more than 35 kg - For stomach cancer: you have had at most 2 prior treatments for advanced disease - For pancreatic cancer: you have had no prior treatments for unresectable disease (prior surgery-related chemotherapy allowed) **You may NOT be eligible if...** - Your tumor does not express Claudin18.2 - You have brain metastases or significant nerve damage (neuropathy grade 2 or higher) - You have a history of another primary cancer - You have had prior exposure to any MMAE-based antibody-drug or prior Claudin18.2-targeted therapies (other than antibodies) - You have clinically significant fluid in your abdomen requiring drainage Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD0901

Antibody-drug conjugate/Biologic

DRUG5-Fluorouracil

Chemotherapy agents

DRUGLeucovorin

Chemotherapy agents

DRUGl-leucovorin

Chemotherapy agents

DRUGIrinotecan

Chemotherapy agents

DRUGNanoliposomal Irinotecan

Chemotherapy agents

DRUGGemcitabine

Chemotherapy agents

Locations(52)

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

Changsha, China

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, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taoyuan, Taiwan

Research Site

Glasgow, United Kingdom

Research Site

Leeds, United Kingdom

Research Site

London, United Kingdom

Research Site

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06219941

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