AZD0901 in participants with advanced solid tumours expressing Claudin18.2

Study identifier:D9800C00001

ClinicalTrials.gov identifier:NCT06219941

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

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.

Medical condition

gastric cancer, Gastroesophageal Junction Cancer

Phase

Phase 2

Healthy volunteers

No

Study drug

AZD0901, 5-Fluorouracil, Leucovorin, l-leucovorin, Irinotecan, Nanoliposomal Irinotecan, Gemcitabine

Sex

All

Estimated Enrollment

123

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 13 Dec 2023
Estimated Primary Completion Date: 29 Apr 2025
Estimated Study Completion Date: 19 Jan 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria