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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-11

Study Completion Date

2027-07-16

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

The study consists of individual modules each evaluating the safety and tolerability of AZD5863 dosed as monotherapy:

* Module 1: AZD5863 intravenous administration
* Module 2: AZD5863 subcutaneous administration

Modules 1 and 2 each consist of two parts: Part A, Dose Escalation and Part B, Dose Expansion.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Module 1: AZD5863 Monotherapy Intravenous (IV)

Module 1: AZD5863 Intravenous (IV) Monotherapy

Group Type EXPERIMENTAL

AZD5863

Intervention Type DRUG

T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells

Module 2: AZD5863 Monotherapy Subcutaneous (SC)

Module 2: AZD5863 Subcutaneous (SC) Monotherapy

Group Type EXPERIMENTAL

AZD5863

Intervention Type DRUG

T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells

Interventions

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AZD5863

T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells

Intervention Type DRUG

Eligibility Criteria

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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 with long-acting anticoagulants or other class of anticoagulants at therapeutic doses

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No