Status:
RECRUITING
A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsors:
Beijing Geek Gene Technology Co., LTD
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Ability to understand and sign a written informed consent document；
- At the date of signing ICF, 18 \~70 years old, male or female；
- Histopathological confirmed advanced solid tumor patients who have failed to standard treatment or intolerance with standard treatment；
- There is at least one resectable tumor lesion that has not received radiation therapy or other local therapies;
- At least one measurable lesion at baseline per RECIST version 1.1；
- The expected survival time is more than 12 weeks;
- ECOG 0-1 points;
- Adequate organ functions
Exclusion
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 18 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06954558
Start Date
March 18 2025
End Date
July 18 2028
Last Update
May 1 2025
Active Locations (1)
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1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China