Advanced Solid Tumors
Conditions
Interventions
Experimental Group:Tumor Microenvironment Modulation Technology via Ethylenediaminetetraacetic Acid (EDTA)-Loaded Micro/Nano-Sheet Layered Double Hydroxides (LDHs)
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years (inclusive), regardless of gender. 2. Patients with histologically or cytologically confirmed advanced solid tumors who have failed standard treatment, have no standard treatment options available, or are not suitable for standard treatment at the current stage. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. 4. Expected survival time of >= 3 months. 5. (Dose Escalation Phase) At least one evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; (Dose Expansion Phase) At least one measurable tumor lesion according to RECIST Version 1.1 (Tumor lesions located in previously irradiated areas or other sites treated with locoregional therapy are generally not considered measurable lesions, unless the lesion shows clear progression or persists for three months after radiotherapy). 6. Adequate function of major organs and bone marrow. 7. Female subjects of childbearing potential must have a negative pregnancy test at the screening stage and use highly effective contraceptive measures from the screening stage to 3 months after the last study intervention. 8. The subject must understand the procedures of this study, be willing to comply with the clinical study protocol to complete the study, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. A history of other malignant tumors within 5 years before the first study intervention, except for the following cases: a. Any other invasive malignant tumors (for which the subject has received adequate treatment) with a disease-free status lasting for more than 3 years, and the investigator assesses that it will not affect the evaluation of tumor efficacy; b. Curable local cancers such as basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast that have been cured. 2. Patients with tumors located in hollow viscera (such as the gastrointestinal tract, urinary tract, major bronchi, etc.) and assessed by the investigator as having a risk of perforation or fistula formation during the study treatment period. 3. Patients whose lesions invade or are adjacent to the heart or large blood vessels (especially large mediastinal blood vessels), or in whom the investigator judges that the tumor has an extremely high risk of invading important blood vessels and causing fatal massive hemorrhage during treatment. 4. Known symptomatic central nervous system (CNS) metastasis or meningeal metastasis. 5. Active hepatitis B at screening (hepatitis B surface antigen [HBsAg] test positive, and hepatitis B virus deoxyribonucleic acid [HBV-DNA] > 500 IU/ml or the lower limit of detection [LLOD] of the study center [only when the LLOD of the study center is higher than 500 IU/ml]); active hepatitis C at screening (hepatitis C virus [HCV] antibody positive and hepatitis C virus ribonucleic acid [HCV-RNA] > the LLOD of the study center). 6. A history of immunodeficiency or positive human immunodeficiency virus (HIV) antibody test. 7. Patients with active autoimmune diseases, or a history of autoimmune diseases with potential for recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for patients with clinically stable autoimmune thyroid disease or type 1 diabetes mellitus. 8. Subjects with active infections who currently require intravenous anti-infective therapy. 9. Presence of clinically significant electrolyte disturbances as judged by the investigator. 10. Patients with any severe and/or uncontrolled cardiovascular diseases. 11. Clinically uncontrolled third-space fluid accumulation (such as pleural effusion, pericardial effusion, ascites, etc.) that the investigator determines is unsuitable for inclusion in this study. 12. Having undergone major surgery (excluding needle biopsy) or suffered a severe injury within 4 weeks before the first study intervention, or planning to undergo elective surgery during the study period. 13. Adverse reactions from previous anti-tumor treatments have not recovered to a level of <= Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 or the level specified in the inclusion/exclusion criteria (except for toxicities that the investigator judges to be without safety risks, such as alopecia, Grade 2 peripheral neurotoxicity, etc.). 14. A history of or current severe mental disorders, or a history of psychoactive substance abuse that cannot be abstained from. 15. A history of other diseases with significant clinical significance that the investigator judges would affect the patient's safety or efficacy, including but not limited to a history of splenectomy. 16. Failure to meet the requirement for the washout period of previous anti-tumor treatments before the fir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence and Frequency of Dose-Limiting Toxicity (DLT);Occurrence and Frequency of Adverse Events (AE)/Serious Adverse Events (SAE) (According to NCI CTCAE v5.0); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR), Disease Control Rate (DCR), Progression-Free Survival (PFS);AUC, CL, Cmin, Cmax, T1/2; | — |
Countries
China
Contacts
Public ContactJunli Xue
Shanghai Tenth People's Hospital
Outcome results
None listed