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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06005493




Registration number
NCT06005493
Ethics application status
Date submitted
16/06/2023
Date registered
22/08/2023

Titles & IDs
Public title
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
Scientific 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
Secondary ID [1] 0 0
2023-000154-20
Secondary ID [2] 0 0
D9750C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Gastro-esophageal Junction Cancer 0 0
Pancreatic Ductal Adenocarcinoma 0 0
Esophageal Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD5863

Experimental: Module 1: AZD5863 Monotherapy Intravenous (IV) - Module 1: AZD5863 Intravenous (IV) Monotherapy

Experimental: Module 2: AZD5863 Monotherapy Subcutaneous (SC) - Module 2: AZD5863 Subcutaneous (SC) Monotherapy


Treatment: Drugs: AZD5863
T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of patients with adverse events
Timepoint [1] 0 0
From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
Primary outcome [2] 0 0
The number of patients with adverse events of special interest
Timepoint [2] 0 0
From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
Primary outcome [3] 0 0
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
Timepoint [3] 0 0
From first dose of study drug until the end of Cycle 1
Primary outcome [4] 0 0
The number of patients with serious adverse events
Timepoint [4] 0 0
From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy
Primary outcome [5] 0 0
Objective Response Rate (ORR)
Timepoint [5] 0 0
From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years)
Secondary outcome [3] 0 0
Duration of response (DoR)
Timepoint [3] 0 0
From the first documented response to progressive disease or death in the absence of disease progression (approx. 2 years)
Secondary outcome [4] 0 0
Progression free Survival (PFS)
Timepoint [4] 0 0
From the start of study treatment/date of randomization to progressive disease or death in the absence of disease progression (approx. 2 years)
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
From the start of study treatment/date of randomization to death (to be followed-up for approx. 2 years)
Secondary outcome [6] 0 0
Pharmacokinetics of AZD5863: Maximum plasma concentration of the study drug (Cmax)
Timepoint [6] 0 0
From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Secondary outcome [7] 0 0
Pharmacokinetics of AZD5863: Area Under the concentration-time curve (AUC)
Timepoint [7] 0 0
From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Secondary outcome [8] 0 0
Pharmacokinetics of AZD5863: Clearance
Timepoint [8] 0 0
From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Secondary outcome [9] 0 0
Pharmacokinetics of AZD5863: Terminal elimination half-life (t 1/2)
Timepoint [9] 0 0
From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Secondary outcome [10] 0 0
Immunogenicity of AZD5863
Timepoint [10] 0 0
From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years)
Secondary outcome [11] 0 0
Preliminary antitumor activity with target expression pre- and post-delivery of AZD5863
Timepoint [11] 0 0
From time of Informed consent, at predefined intervals (including screening, on-treatment or end of treatment) throughout the study (over approx. 2 years)

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/12/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Shandong
Country [6] 0 0
France
State/province [6] 0 0
Toulouse Cedex 09
Country [7] 0 0
France
State/province [7] 0 0
Villejuif Cedex
Country [8] 0 0
Japan
State/province [8] 0 0
Chuo-ku
Country [9] 0 0
Japan
State/province [9] 0 0
Kashiwa
Country [10] 0 0
Japan
State/province [10] 0 0
Koto-ku
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Netherlands
State/province [12] 0 0
Amsterdam
Country [13] 0 0
Netherlands
State/province [13] 0 0
Groningen
Country [14] 0 0
Netherlands
State/province [14] 0 0
Rotterdam
Country [15] 0 0
Taiwan
State/province [15] 0 0
Kaohsiung
Country [16] 0 0
Taiwan
State/province [16] 0 0
Tainan City
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taoyuan
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Dundee
Country [19] 0 0
United Kingdom
State/province [19] 0 0
London
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Oxford
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06005493