PIN in Combination With Anti-PD1 in Previously Treated Solid Tumor

Launched by CHINESE PLA GENERAL HOSPITAL · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment combination called PIN and anti-PD1 for adults with advanced solid tumors that have not responded to previous therapies. The main goals are to check how safe this combined treatment is, how well it can fight tumors, and to understand how it affects the immune system and the tumor environment. The study will enroll about 20 to 30 participants who are between 18 and 75 years old and have specific types of advanced cancer that have not responded well to other treatments.

To be eligible for this trial, participants should have a certain level of health and be able to provide a measurable tumor sample. They should not be currently taking certain medications or have specific health issues that could interfere with the study. Those who join the trial will receive the PIN and anti-PD1 treatment and will be monitored closely for any side effects and changes in their condition. It's important for potential participants to understand that they need to be willing to undergo additional tests and share their health information as part of the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-75 (inclusive).
• • 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and Estimated life expectancy of more than 3 months.
• • 3. Histopathological confirmed advanced or metastatic solid tumors failed to at least first-line treatment or initially diagnosed advanced/metastatic solid tumors that have no National Comprehensive Cancer Network (NCCN) guideline recommended standard first-line therapy.
• • 4. Patients with previous anti-PD-1/ PD-L1 antibodies treatment resistance,non-response,or low response tumor types (such as hepatic carcinoma,et al) .
• • 5. At least one measurable lesion at baseline according to RECIST 1.1.
• • 6. Patients with injectable lesions (those suitable for direct injection or injection with the assistance of medical imaging), defined as follows: at least one injectable lesion in the skin, mucous membrane, subcutaneous tissue, lymph node or visceral organ with a longest diameter ≥10 mm.
• • 7. Subjects are willing to accept tumor rebiopsy in the process of this study.
• 8. Adequate organ function as defined by the following criteria:
• • Absolute neutrophil count (ANC) ≥ 1 x 10\^9/L, Platelet count ≥50 x 10\^9/ L, hemoglobin (Hgb) ≥ 80g/L ;
• • Serum creatinine≤1.5 upper limit of normal (ULN) or creatinine clearance (as estimated by Cockcroft Gault) ≥60 mL/min;
• • Serum aspartate amino transferase (AST) and alanine aminotransferase (ALT), ≤3.0 x ULN (≤5 x ULN for patients with liver cancer or metastases); Total serum bilirubin ≤1.5 x ULN(≤3 x ULN for patients with liver cancer or metastases);
• • Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings;
• • International Normalized Ratio (INR) ≤ 1.5 times the upper limit of normal (ULN), and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN;
• • Baseline oxygen saturation \>91% on room air.
• • 9. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to \<= grade 1 Toxicity (except for hematological toxicities and clinically non-significant toxicities such as alopecia).
• • 10. Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.
• • 11. Voluntarily participate in this clinical trial and sign an informed consent form.
• Exclusion Criteria:
• • 1. Subjects are being treated with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
• • 2. Active central nervous system disease involvement (but allow patients with prior brain metastases treated at least 4 weeks prior to enrollment that are clinically stable and do not require intervention), or prior history of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥3 drug-related Central Nervous System (CNS) toxicity.
• • 3. Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management.
• • 4. Any serious underlying medical (eg, pulmonary, renal, hepatic,gastrointestinal, or neurological) or psychiatric condition or any issue that would limit compliance with study requirements.
• • 5. Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.
• • 6. Received cytotoxic chemicals, monoclonal antibodies, immunotherapy or other intervene within 4 weeks or 5 half-lives before enrollment.
• • 7. Received radiotherapy within 3 months before enrollment.
• • 8. Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy.
• • 9. The presence of uncontrollable serous membrane fluid, such as massive pleural effusion or ascites.
• • 10. Previous or concurrent cancer within 3 years prior to treatment start except for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\].
• • 11. Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
• • 12. Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation.
• • 13. History of allergy or intolerance to study drug components.
• • 14. Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented.
• • 15. Being participating any other trials or withdraw within 4 weeks.
• • 16. Researchers believe that other reasons are not suitable for clinical trials.