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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)

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Trial Profile

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 of Trial: Phase II

Latest Information Update: 20 Mar 2025

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At a glance

  • Drugs CMG 901 (Primary) ; Fluorouracil (Primary) ; Folinic acid (Primary) ; Gemcitabine (Primary) ; Irinotecan (Primary) ; Irinotecan (Primary) ; Levofolinic acid (Primary)
  • Indications Adenocarcinoma; Biliary cancer; Cholangiocarcinoma; Gallbladder cancer; Gastric cancer; Oesophageal cancer; Pancreatic cancer; Pancreatic ductal carcinoma; Solid tumours
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors AstraZeneca

Most Recent Events

  • 21 Jan 2025 Number of treatment arms are increased from 2 to 3 by the addition of Sub-study 3 treatment arm which will investigate the study drug in newly added indications namely: biliary tract cancer, cholangiocarcinoma and gall bladder cancer.
  • 21 Jan 2025 Planned number of patients changed from 123 to 190.
  • 21 Jan 2025 Planned End Date changed from 19 Jan 2027 to 31 Dec 2026.

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