Trial Title:
A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma
NCT ID:
NCT06084884
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular Carcinoma
Liver Cancer
Liver Neoplasm
advanced HCC
HCC
Metastatic Liver Cancer
CAR-T
CART
AZD5851
T-cell
Cell Therapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Open-label
Intervention:
Intervention type:
Biological
Intervention name:
AZD5851
Description:
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs)
to produce AZD5851.
During AZD5851 production, subjects may receive bridging therapy for disease control.
Upon successful generation of AZD5851 product, subjects will receive treatment with
AZD5851 therapy.
Study treatment will include lymphodepleting chemotherapy followed by one dose of AZD5851
administered by intravenous (IV) infusion.
Arm group label:
AZD5851
Other name:
Cell Therapy
Summary:
A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent
hepatocellular carcinoma.
Detailed description:
This first-time in human, single-arm, open-label multicentre Phase I/II study will
evaluate the safety, tolerability, antitumour activity, cellular kinetics,
pharmacodynamics, and immunogenicity of AZD5851 in adult participants with GPC3+
advanced/recurrent HCC, where at least one line of prior therapy has failed/or was
intolerable, or participant/investigator decision.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Participant must be 18 years or older and has voluntarily agreed to participate by
giving written informed consent.
2. Participants with confirmed advanced/recurrent or metastatic and/or unresectable HCC
based on histopathological findings
3. Completed or were unable to tolerate at least one prior line of standard systemic
therapy for HCC and/or participant/investigator decision.
4. GPC3-positive tumour as determined by a central laboratory using an analytically
validated IHC assay
5. Barcelona Clinic Liver Cancer Stage B (if not amenable to local treatment/surgery)
or C prior to apheresis
6. Child-Pugh score: Grade A
7. Participants with HBV and HCV undergoing management of these infections per
institutional practice.
Exclusion Criteria:
1. Active or prior documented gastrointestinal (GI) variceal bleed or history of upper
GI bleeding, ulcers, or esophageal varices with bleeding within 12 months
2. History of liver transplantation or on waiting list
3. Current clinically significant ascites
4. Main portal vein thrombus, or tumor thrombus invasion of mesenteric vein / inferior
vena cava
5. Uncontrolled intercurrent illness
6. Active Infections
7. Positive serology for HIV
8. History of hepatic encephalopathy within 12 months prior to treatment allocation
9. History of chronic or recurrent (within the last year) severe autoimmune or immune
mediated disease requiring steroids or other immune-suppressive treatments.
10. Prior treatment with any CAR-T therapy directed at any target or any therapy that is
targeted to GPC3.
11. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy,
endocrine therapy, targeted therapy, biologic therapy, tumour embolisation, or
monoclonal antibodies, investigational product) within 5 half-lives or ≤ 21 days
(whichever is shortest).
Gender:
All
Minimum age:
18 Years
Maximum age:
130 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pittsburgh
Zip:
15237
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Not yet recruiting
Start date:
November 27, 2023
Completion date:
December 13, 2027
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/NCT06084884
