A Single-arm, Open-label Study of GK01 in Combination With or Without Chemotherapy for the Adjuvant Treatment of Solid Tumors

Recruiting now · Phase 1

Conditions studied: Solid Tumors

In brief

This study is an open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.

Key facts

Study ID

NCT07351903

Run by

Tianjin Medical University Cancer Institute and Hospital

People needed

15

Starts

2025-10-16

Expected to finish

2029-02-14

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Inoperable or metastatic (Stage IV) solid tumors.
• 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 solid 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.
• Allergy to any components of the drugs planned.
• Previous radiotherapy within 28 days before signing the ICF.
• History of active tuberculosis infection within 1 year before screening.
• Concurrent or previous history of interstitial lung disease or interstitial pneumonia; presence of chronic lung disease or other respiratory conditions that significantly impair lung function.
• Diagnosis of active autoimmune disease or a history of autoimmune disease that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or at risk of such conditions.
• Investigator-assessed clinically significant thyroid dysfunction.
• Cardiovascular diseases with clinical significance.
• No contraindications to curative resection of the primary tumor.
• Attenuated or inactivated vaccines within 28 days before signing the I form, or planned administration of such vaccines during the screening period.
• Comorbidities or other conditions are likely to affect protocol compliance or suitability for participation in this study.
• Female subjects who are pregnant or breastfeeding.

Where it is running

• Tianjin Cancer Hospital Airport Hospital — Tianjin, China (enrolling)

Full record on ClinicalTrials.gov

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