NCT07351903 A Single-arm, Open-label Study of GK01 in Combination With or Without Chemotherapy for the Adjuvant Treatment of Solid Tumors
| NCT ID | NCT07351903 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2028-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-10-16 with a primary completion date of 2028-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07351903 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07351903 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07351903 currently recruiting?
Yes, NCT07351903 is actively recruiting participants. Contact the research team at haojihui@tjmuch.com for enrollment information.
Where is the NCT07351903 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07351903 clinical trial?
NCT07351903 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 15 participants.