Study identifier:D9750C00001
ClinicalTrials.gov identifier:NCT06005493
EudraCT identifier:2023-000154-20
CTIS identifier:N/A
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
gastric cancer
Phase 1/2
No
AZD5863
All
200
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Module 1: AZD5863 Monotherapy Intravenous (IV) Module 1: AZD5863 Intravenous (IV) Monotherapy | Drug: AZD5863 T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells |
Experimental: Module 2: AZD5863 Monotherapy Subcutaneous (SC) Module 2: AZD5863 Subcutaneous (SC) Monotherapy | Drug: AZD5863 T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells |