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

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 May 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Age ≥ 18 at the time of signing the informed consent
- Histologically confirmed diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas
- Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (IHC)
- Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
- Predicted life expectancy of ≥ 12 weeks
- Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol
- Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol
- Must have received at least one prior line of systemic therapy in the advanced/metastatic setting

Exclusion Criteria

- Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol
- Participant experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy
- Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS)
- Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment
- central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent
- Infectious disease including active human immunodeficiency virus (HIV), active hepatitis B/C, uncontrolled infection with EBV, uncontrolled active systemic fungal, bacterial or other infection
- Cardiac conditions as defined by the protocol
- History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
- Participant requires chronic immunosuppressive therapy
- Participants on anticoagulation therapy

Sort by status

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

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]