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

Last updated: April 15, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1/2

Condition

Pancreatic Cancer

Digestive System Neoplasms

Esophageal Cancer

Treatment

AZD5863

Clinical Study ID

NCT06005493
D9750C00001
2023-000154-20
2023-504139-42-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 Criteriain Solid Tumors (RECIST) v1.1

  • Must show positive CLDN18.2 expression in tumor cells as determined by centralimmunohistochemistry (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 doseas defined by the protocol

  • Contraceptive use by men or women should be consistent with local regulations, asdefined by the protocol

  • Must have received at least one prior line of systemic therapy in theadvanced/metastatic setting

Exclusion

Key Exclusion Criteria:

  • Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria forAdverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol

  • Participant experienced unacceptable cytokine release syndrome (CRS) or ImmuneEffector 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 activationsyndrome (MAS)

  • Active or prior documented autoimmune or inflammatory disorders within 3 years ofstart of treatment

  • central nervous system (CNS) metastases or CNS pathology, as defined by theprotocol, within 3 months prior to consent

  • Infectious disease including active human immunodeficiency virus (HIV), activehepatitis 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 scheduledfirst dose of study intervention

  • Participant requires chronic immunosuppressive therapy

  • Participants on anticoagulation therapy

Study Design

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: AZD5863
Phase: 1/2
Study Start date:
July 11, 2023
Estimated Completion Date:
December 16, 2026

Study 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).

Connect with a study center

  • Research Site

    Beijing, 101199
    China

    Active - Recruiting

  • Research Site

    Shandong,
    China

    Active - Recruiting

  • Research Site

    Toulouse, 31059
    France

    Active - Recruiting

  • Research Site

    Toulouse Cedex 09, 31059
    France

    Site Not Available

  • Research Site

    Villejuif Cedex, 94805
    France

    Active - Recruiting

  • Research Site

    Chuo-ku, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Kashiwa, 227-8577
    Japan

    Active - Recruiting

  • Research Site

    Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Seodaemun-gu, 03722
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Amsterdam, 1081 HV
    Netherlands

    Active - Recruiting

  • Research Site

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Research Site

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Research Site

    Kaohsiung, 80756
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan, 704
    Taiwan

    Site Not Available

  • Research Site

    Tainan City, 70403
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan, 00333
    Taiwan

    Active - Recruiting

  • Research Site

    Dundee, DD1 9SY
    United Kingdom

    Active - Recruiting

  • Research Site

    London, E1 1BB
    United Kingdom

    Active - Recruiting

  • Research Site

    Oxford, OX3 7LE
    United Kingdom

    Active - Recruiting

  • Research Site

    Wirral, CH63 4JY
    United Kingdom

    Active - Recruiting

  • Research Site

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Research Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10065
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.