Testing GK01 for advanced solid tumors
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
PHASE1 · Tianjin Medical University Cancer Institute and Hospital · NCT06954558
This study is testing a new treatment called GK01 to see if it can help people with advanced solid tumors who haven't had success with other therapies.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06954558 on ClinicalTrials.gov |
What this trial studies
This Phase I clinical trial evaluates the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors. It is an open-label, single-arm study, meaning all participants will receive the GK01 injection without a control group. The trial aims to determine how well GK01 works in patients who have not responded to standard treatments or cannot tolerate them. Participants must have measurable tumor lesions and adequate organ function to qualify for the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with histopathologically confirmed advanced solid tumors that have failed standard treatment.
Not a fit: Patients with tumors that are not resectable or those who have received prior radiation or local therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.
How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in evaluating new treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tianjin
- Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (RECRUITING)
Study contacts
- Study coordinator: Jihui Hao
- Email: haojihui@tjmuch.com
- Phone: +86-02223340123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumors, efficacy, safety, PK, TILs