Clinical trial · Interventional
A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor
The Phase I, Open-label, Single-arm Clinical Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Patients With Advanced Solid Tumors
NCT06954558CI-TRIAL-00089202GUARDIANrecruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GK01 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GK01 injection
- description
- Autologous tumor-reactive T cells injection
- interventionNames
- Drug: GK01 Injection
Primary outcomes (1)
- measure
- Safety and Tolerability
- timeFrame
- 2 years
- description
- The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events).
Secondary outcomes (7)
- measure
- PK
- timeFrame
- 2 years
- description
- Levels of T-cell Receptor copies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
1. Ability to understand and sign a written informed consent document； 2. At the date of signing ICF, 18 \~70 years old, male or female； 3. Histopathological confirmed advanced solid tumor patients who have failed to standard treatment or intolerance with standard treatment； 4. There is at least one resectable tumor lesion that has not received radiation therapy or other local therapies; 5. At least one measurable lesion at baseline per RECIST version 1.1； 6. The expected survival time is more than 12 weeks; 7. ECOG 0-1 points; 8. Adequate organ functions
References
Publications (0)
Data not yet available
No reference posted for this study.