Hepatocellular Carcinoma (HCC), Unresectable Hepatocellular Cancer
Conditions
Keywords
GKL-006, Unresectable hepatocellular carcinoma, HCC, Immunotherapy, Cell therapy, Safety
Brief summary
This is a Phase 1b study of GKL-006 Injection in patients with unresectable hepatocellular carcinoma.
Detailed description
This Phase 1b study evaluates multiple doses of GKL-006 Injection in participants with unresectable hepatocellular carcinoma (HCC). The purpose of this study is to evaluate the safety and tolerability of multiple doses of GKL-006 Injection. The study will also evaluate pharmacokinetic and pharmacodynamic characteristics of GKL-006 Injection, how it affects the body, and whether it shows preliminary anti-tumor activity in patients with HCC according to mRECIST. Participants will receive GKL-006 Injection and TACE treatment. They will be followed for adverse events, tumor response, disease progression, subsequent anti-tumor therapy, and survival.
Interventions
An iNKT cell therapy
PROCEDURETransarterial chemoembolization (TACE)
A standard locoregional therapy for hepatocellular carcinoma
Sponsors
Beijing Gene Key Life Technology Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Voluntarily participates in the study and provides written informed consent. * Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma. * Has CNLC stage II to IIIa disease. * Has not received transarterial chemoembolization within 6 months before screening. * Has at least one measurable lesion according to mRECIST. * Child-Pugh class A or B. * ECOG performance status of 0 - 2. * Has not received radiotherapy, chemotherapy, targeted therapy, or immunosuppressive therapy within 4 weeks before screening.
Exclusion criteria
* Has a known allergy to the investigational product or related components, including human serum albumin. * Has another incurable malignancy within 5 years before screening or concurrently, except for cured basal cell carcinoma of the skin, carcinoma in situ, or breast cancer without recurrence for more than 3 years after radical surgery. * Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma. * Has major vascular invasion on imaging. * Has hepatic encephalopathy within 4 weeks before screening. * Has clinically symptomatic ascites or pleural effusion requiring drainage, or has undergone thoracic or abdominal fluid drainage within 2 weeks before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Treatment-Related Adverse Events and Safety/Tolerability Risks | From the start of study treatment through 14 days after the fourth treatment; treatment-related adverse events will continue to be assessed according to the study protocol. | Treatment-related adverse events and laboratory abnormalities will be assessed and graded according to NCI CTCAE v5.0. Safety and tolerability risks include study treatment-related adverse events or laboratory abnormalities occurring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) Based on mRECIST | From enrollment to the first documented disease progression or death from any cause, up to 18 months. | PFS defined as the time from enrollment to disease progression assessed according to mRECIST or death from any cause, whichever occurs first. |
| Overall Survival | From enrollment until death or the end of study follow-up, approximatelly 30 months. | The time from enrollment to death from any cause. |
| One-Year Overall Survival Rate (1Y-OS) | 1 year after enrollment. | The proportion of participants who are alive 1 year after enrollment. |
| Time to Progression (TTP) | From enrollment until the first documented disease progression or the end of study follow-up, up to 18 months. | The time from enrollment to the first documented disease progression according to mRECIST. |
| Objective Response Rate (ORR) | From enrollment until disease progression, initiation of new anti-tumor therapy, death, or the end of study follow-up, up to 18 months. | The rate of participants with a best overall response of complete response (CR) or partial response (PR) according to mRECIST. |
| Duration of Response (DOR) Based on mRECIST | From first documented response until disease progression, death, or the end of study follow-up, up to 18 months. | The time from the first documented CR or PR according to mRECIST to disease progression or death from any cause, whichever occurs first. |
| Disease Control Rate (DCR) Based on mRECIST | From enrollment until disease progression, initiation of new anti-tumor therapy, death, or the end of study follow-up, up to 18 months. | The rate of participants with a best overall response of CR, PR, or stable disease (SD) according to mRECIST. |
| Pharmacokinetic characterization of maximum observed plasma concentration (Cmax) of GKL-006 | From 60 minutes before the first dose through 60 days. | Maximum observed plasma concentration of GKL-006 following intravenous administration according to protocol. |
| Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax) of GKL-006 | From 60 minutes before the first dose through 60 days. | Time to reach the maximum observed plasma concentration of GKL-006 following a single intravenous administration. |
| Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC) of GKL-006 | From 60 minutes before the first dose through 60 days. | Area under the plasma concentration-time curve of GKL-006 following a single intravenous administration. |
| Pharmacokinetic characterization of terminal elimination half-life (t½) of GKL-006 | From 60 minutes before the first dose through 60 days. | Terminal elimination half-life of GKL-006 calculated from plasma concentration-time data following a single intravenous administration. |
| Pharmacodynamic Biomarkers of NK cells | From 60 minutes before the first dose through 60 days. | Immune cell subsets |
| Pharmacodynamic Biomarkers of T cells | From 60 minutes before the first dose through 60 days. | Immune cell subsets |
Countries
China
Outcome results
None listed