NCT07713290Active, not recruitingPhase 1
A Phase 1b Study of GKL-006 Injection in Patients With Unresectable Hepatocellular Carcinoma
An Open-Label, Multiple-Dose Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006 Injection in Patients With Unresectable Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
This is a Phase 1b study of GKL-006 Injection in patients with unresectable hepatocellular carcinoma.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 12 Jun 2026
- Start date
- 3 Apr 2025
- Primary completion date
- 12 Nov 2026
- Lead sponsor
- Beijing Gene Key Life Technology Co., Ltd
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07713290
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 6
- From 3 Apr 2025 to the primary completion date, 12 Nov 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma.
- 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.
Other illness
- 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.
Lab values
- Has a known allergy to the investigational product or related components, including human serum albumin.
Other
- Has major vascular invasion on imaging.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing You An Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| First Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.