Trial Title:
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
NCT ID:
NCT06005493
Condition:
Gastric Cancer
Gastro-esophageal Junction Cancer
Pancreatic Ductal Adenocarcinoma
Esophageal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Stomach Neoplasms
Conditions: Keywords:
CLDN18.2 / Claudin 18.2
CD3
T cell-engaging bi-specific antibody
Gastric cancer
Gastro-esophageal junction cancer
Pancreatic ductal adenocarcinoma
Solid tumors
AZD5863
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
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 purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AZD5863
Description:
T cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells
and CD3 on T cells
Arm group label:
Module 1: AZD5863 Monotherapy Intravenous (IV)
Arm group label:
Module 2: AZD5863 Monotherapy Subcutaneous (SC)
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.
Detailed 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).
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
101199
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shandong
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kashiwa
Zip:
227-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tainan City
Zip:
70403
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taoyuan
Zip:
00333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dundee
Zip:
DD1 9SY
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
E1 1BB
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wirral
Zip:
CH63 4JY
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
July 11, 2023
Completion date:
December 11, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06005493
