NCT07407985
Active, not recruiting
Phase 1
A Open-label, Single-arm Clinical Trial Designed to Evaluate the Safety, Pharmacokinetic , and Efficacy of the GK01 Cell Injection in Combination With a PD-1 Monoclonal Antibody for the Treatment of Advanced Solid Tumors.
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country15 target enrollmentStarted: December 4, 2025Last updated:
InterventionsGK01 combination with PD-1 monoclonal antibody
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability
Overview
Brief Summary
This study is a open-label, single-arm clinical trial designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of the GK01 cell injection in combination with a PD-1 monoclonal antibody for the treatment of advanced solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed Consent Form (ICF) .
- •Aged 18 to 70 years (inclusive) at the time of signing the ICF.
- •Histologically or cytologically confirmed advanced solid tumors that are metastatic or locally recurrent (including but not limited to small cell lung cancer, non-small cell lung cancer, gastric cancer, colorectal cancer, etc.);
- •ECOG score of 0 \~1 .
- •Expected survival time is more than 12 weeks.
- •Negative blood pregnancy test for females of childbearing potential is required.
Exclusion Criteria
- •Patients with central nervous system (CNS) metastasis, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, etc.
- •History of bone marrow or organ transplantation;
- •History of other primary malignancies within 5 years prior to study treatment
- •Hepatitis B surface antigen (HBsAg) positivity; With negative HBsAg but positive hepatitis B core antibody (HBcAb) ,and if peripheral blood hepatitis B virus (HBV) DNA positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Both Treponema pallidum-specific and non-specific antibody tests are positive.
- •Patients with a known allergy to any component of the study drugs.
- •Received treatment with anti-PD-1, anti-PD-L1 therapeutic antibodies, or drugs targeting this pathway.
- •Received any investigational drug or systemic anticancer therapy within 28 days before infusion (or 5 half-lives of the drug, whichever is considered more appropriate by the investigator).
- •Received wide-field radiotherapy within 28 days prior to signing the ICF, with the exception of palliative radiotherapy to non-target lesions for symptom relief, administered at least 14 days before signing the ICF or planned during the study period.
- •Undergone major surgery within 28 days prior to signing the ICF, or are scheduled to undergo major surgery during the study period.
- •At the time of signing the ICF, any toxicity from prior anti-cancer therapy (except alopecia and pigmentation) that has not recovered to Grade 1 (excluding lymphocytopenia) or to baseline level (according to NCI CTCAE version 5.0).
Arms & Interventions
GK01 PD-1 monoclonal
Experimental
GK01 combination with PD-1 monoclonal antibody
Intervention: GK01 combination with PD-1 monoclonal antibody (Drug)
Outcomes
Primary Outcomes
Safety and Tolerability
Time Frame: 2 years
The incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events).
Secondary Outcomes
- Pharmacokinetic(2 years)
- Objective response rate (ORR)(2 years)
- Progression-free Survival（PFS）(2 years)
- Duration of Response（DOR）(2 years)
- Overall survival（OS）(2 years)
- Disease Control Rate（DCR）(2 years)
Investigators
Study Sites (1)
Loading locations...
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