A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor
- Conditions
- Advanced Solid Tumors
- Interventions
- Drug: GK01 Injection
- Registration Number
- NCT06954558
- Brief Summary
This study is a Phase I, open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GK01 injection GK01 Injection Autologous tumor-reactive T cells injection
- Primary Outcome Measures
Name Time Method Safety and Tolerability 2 years The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events).
- Secondary Outcome Measures
Name Time Method PK 2 years Levels of T-cell Receptor copies
Objective response rate (ORR) 2 years Progress-free survival(PFS) 2 years PFS will be assessed from the first GK01 infusion to death from any cause or the first assessment of progression (Assessed based on RECIST criteria)
Overall survival (OS ) 2 years OS will be assessed from the first GK01 infusion to death from any cause (Assessed based on RECIST criteria)
Disease control rate (DCR) 2 years Patient Quality of Life 2 years EORTC(European Organisation for Research and Treatment of Cancer) QLG (Quality of Life Group)Core Questionnaire (EORTC QLQ-C30)
PD marker 2 years Concentration levels of serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α
Trial Locations
- Locations (1)
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, China