Actively Recruiting
A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-05-01
15
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
B
Beijing Geekgene Technology Co., LTD
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign a written informed consent document
- Age between 18 and 70 years, male or female
- Histopathologically confirmed advanced solid tumor with failure or intolerance to standard treatment
- At least one resectable tumor lesion without prior radiation or local therapy
- At least one measurable lesion at baseline per RECIST version 1.1
- Expected survival time of more than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ functions
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
Research Team
J
Jihui Hao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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