GK01 with or without chemotherapy after surgical removal of solid tumors

The Single-arm Open-label Clinical Study Evaluating the Use of GK01 Cell Injection in Combination With or Without Chemotherapy for the Adjuvant Treatment of Solid Tumors

This trial tries GK01, alone or with chemotherapy, after surgery to help people with resectable solid tumors stay cancer-free.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Locations: 1 site (Tianjin)
• Trial ID: NCT07351903 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label phase 1 trial testing GK01 injection given as adjuvant therapy with or without standard chemotherapy after curative-intent surgery for a variety of histologically confirmed solid tumors. The primary focus is on safety and pharmacokinetics, with collection of preliminary signals of anti-tumor activity and recurrence outcomes. Eligible participants are adults (18–70 years) with localized, resectable primary tumors who have not received prior therapy for the primary lesion and have ECOG performance status 0–1. The trial is conducted at Tianjin Cancer Hospital Airport Hospital in Tianjin, China, and participants must be able to undergo radical resection at the site.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–70 with histologically confirmed, resectable primary solid tumors who have not received prior treatment for the primary lesion and have ECOG 0–1.

Not a fit: Patients with inoperable or metastatic (stage IV) disease, central nervous system metastases or major CNS disorders, prior organ or bone marrow transplantation, or poor performance status are unlikely to benefit from this adjuvant protocol.

Why it matters

Potential benefit: If successful, adding GK01 after surgery could reduce the risk of cancer recurrence and improve long-term outcomes for patients with resectable solid tumors.

How similar studies have performed: Adjuvant systemic therapies have benefited some tumor types, but GK01 is an investigational agent with limited prior human data and lacks large published efficacy results.

Eligibility criteria

* Ability to understand and sign a written informed consent document.
* At the date of signing ICF, 18 \~70 years old, male or female.
* Patients with solid tumors confirmed by histopathology (including but not limited to pancreatic cancer, cholangiocarcinoma, gastric cancer, etc.) who are judged by investigator to be capable of undergoing radical total resection of the primary tumor for the purpose of cure.
* No treatment for the primary tumor was received before surgical resection (no induction therapy or recurrent disease).
* The expected survival time is more than 12 weeks;.
* ECOG 0-1 points.

Exclusion Criteria:

* 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 this trial is running

Tianjin

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

Study contacts

• Study coordinator: Jihui Hao

Conditions Solid Tumors