Study of AZD5863 in Adult Participants with Advanced or Metastatic Solid Tumors

Study identifier:D9750C00001

ClinicalTrials.gov identifier:NCT06005493

EudraCT identifier:2023-000154-20

CTIS identifier:N/A

Recruiting

Official Title

A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T cell-engaging Bispecific Antibody that Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants with Advanced or Metastatic Solid Tumors

Medical condition

gastric cancer, Gastro-esophageal junction cancer

Phase

Phase 1/2

Healthy volunteers

No

Study drug

AZD5863

Sex

All

Estimated Enrollment

200

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 11 Jul 2023
Estimated Primary Completion Date: 11 Dec 2026
Estimated Study Completion Date: 11 Dec 2026

Study design

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

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria