A Phase 1b Study of GKL-006 Injection in Patients With Unresectable Hepatocellular Carcinoma

Phase 1Active Not RecruitingNCT07713290

Beijing Gene Key Life Technology Co., Ltd6 enrolled

Overview

This is a Phase 1b study of GKL-006 Injection in patients with unresectable hepatocellular carcinoma.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma (HCC)Unresectable Hepatocellular Cancer

Interventions

GKL-006 InjectionDRUG

An iNKT cell therapy

Transarterial chemoembolization (TACE)PROCEDURE

A standard locoregional therapy for hepatocellular carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing You An Hospital

Beijing, Beijing Municipality, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Outcomes

Primary Outcomes

Incidence and Severity of Treatment-Related Adverse Events and Safety/Tolerability Risks

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.

Time frame: 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.

Secondary Outcomes

Progression-Free Survival (PFS) Based on mRECIST

PFS defined as the time from enrollment to disease progression assessed according to mRECIST or death from any cause, whichever occurs first.

Time frame: From enrollment to the first documented disease progression or death from any cause, up to 18 months.

Overall Survival

The time from enrollment to death from any cause.

Time frame: From enrollment until death or the end of study follow-up, approximatelly 30 months.

One-Year Overall Survival Rate (1Y-OS)

The proportion of participants who are alive 1 year after enrollment.

Time frame: 1 year after enrollment.

Time to Progression (TTP)

The time from enrollment to the first documented disease progression according to mRECIST.

Time frame: From enrollment until the first documented disease progression or the end of study follow-up, up to 18 months.

Objective Response Rate (ORR)

The rate of participants with a best overall response of complete response (CR) or partial response (PR) according to mRECIST.

Data from ClinicalTrials.gov

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