A Phase I/II study to evaluate AZD5851 in patients with GPC3+ advanced/recurrent hepatocellular carcinoma.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
94
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.
Research Site
Phoenix, Arizona, United States
Research Site
Duarte, California, United States
1. Incidence of participants with dose-limiting toxicities (DLTs), adverse events (AEs), including adverse events of special interest (AESI) and serious adverse events (SAEs). Determination of the recommended dose of AZD5851 for expansion phase
Determine if treatment with AZD5851 is safe and tolerable through assessment of DLTs, AEs, SAEs and changes from baseline in vital signs, ECGs, and laboratory parameters
Time frame: Through study completion, an average of 2 years
1. Proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR)
Evaluation of the efficacy of the treatment by assessment of the Overall Response Rate according to RECIST v1.1 (ORR)
Time frame: Through study completion, an average of 2 years
2. Interval between the date of AZD5851 infusion dose and first documented evidence of CR or PR
Evaluation of the efficacy of the treatment by assessment of time to first response (TTR)
Time frame: Through study completion, an average of 2 years
3. Proportion of participants who have a confirmed CR, PR, or who have stable disease (SD) for at least 5 weeks after the date of AZD5851 infusion
Evaluation of the efficacy of the treatment by assessment of disease control rate according to RECIST v1.1 (DCR)
Time frame: Through study completion, an average of 2 years
4. The proportion of participants who have a confirmed response (CR/PR) with a duration of at least a specific number of months
Evaluation of the efficacy of the treatment by assessment of durable response rate according to RECIST v1.1 (DRR)
Time frame: Through study completion, an average of 2 years
5. The best response the participant achieved according to RECIST v1.1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Orange, California, United States
Research Site
San Francisco, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Jacksonville, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Westwood, Kansas, United States
Research Site
Rochester, Minnesota, United States
Research Site
Hackensack, New Jersey, United States
...and 8 more locations
Evaluation of the efficacy of the treatment by assessment of best overall response according to RECIST v1.1 (BoR)
Time frame: Through study completion, an average of 2 years
6. Interval between the date of first documented objective response date of first documented disease progression or the last evaluable assessment in the absence of progression
Evaluation of the efficacy of the treatment by assessment of duration of response according to RECIST v1.1 (DoR)
Time frame: Through study completion, an average of 2 years
7. Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause
Evaluation of the efficacy of the treatment by assessment of progression-free survival (PFS)
Time frame: Through study completion, an average of 2 years
8. Interval between the date of first T cell infusion and date of death due to any cause
Evaluation of the efficacy of the treatment by assessment of overall survival (OS)
Time frame: Through study completion, an average of 2 years
9. Pharmacokinetics - maximum serum concentration of AZD5851
Maximum blood concentration (Cmax)
Time frame: Through study completion, an average of 2 years
10. Pharmacokinetics -time to peak serum concentration of AZD5851
Time to peak (maximum) blood concentration (Tmax)
Time frame: Through study completion, an average of 2 years
11. Pharmacokinetics -time to last measurable serum concentration of AZD5851
Time to last detectable blood concentration (Tlast)
Time frame: Through study completion, an average of 2 years
12. Pharmacokinetics - Exposure of AZD5851
Area under the curve (AUC)
Time frame: Through study completion, an average of 2 years