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

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AstraZeneca

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Gastro-esophageal Junction Cancer
Gastric Cancer
Esophageal Adenocarcinoma
Pancreatic Ductal Adenocarcinoma

Treatments

Drug: AZD5863

Study type

Interventional

Funder types

Industry

Identifiers

NCT06005493
D9750C00001
2023-000154-20 (EudraCT Number)

Details and patient eligibility

About

This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.

Full description

This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD5863 monotherapy administered intravenously (Module 1), or AZD5863 monotherapy administered subcutaneously (Module 2) in patients with advanced or metastatic solid tumors. Each module contains dose-escalation (Part A) and dose-expansion (Part B).

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Module 1: AZD5863 Monotherapy Intravenous (IV)
Experimental group
Description:
Module 1: AZD5863 Intravenous (IV) Monotherapy
Treatment:
Drug: AZD5863
Module 2: AZD5863 Monotherapy Subcutaneous (SC)
Experimental group
Description:
Module 2: AZD5863 Subcutaneous (SC) Monotherapy
Treatment:
Drug: AZD5863

Trial contacts and locations

23

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Central trial contact

AstraZeneca Clinical Study Information Center

Data sourced from clinicaltrials.gov

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