First in Human Study of YB1-X7 Injection

Launched by SHANGHAI SALVECTORS BIOTECHNOLOGY LTD. · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called YB1-X7 injection for patients with advanced solid tumors, which are cancerous growths that have spread and are difficult to treat. The treatment uses a modified type of Salmonella bacteria that targets areas of the tumor with low oxygen levels, allowing it to grow and release a therapeutic agent that helps kill cancer cells. The study aims to see how safe this treatment is, how well it works, and how the body processes it.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of advanced or metastatic solid tumors that have not responded to standard treatments. They should have measurable tumors and must be in relatively good health with a life expectancy of at least three months. Participants will receive the injection directly into their tumors, and they will be monitored closely for any side effects or changes in their condition. This trial is not yet recruiting, but it offers hope for patients who have limited treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years, no gender limitatlon
• • 2. Subjects with advanced or metastatic solid tumors confirmed by pathological histology.
• • 3. Subjects with advanced malignant solid tumors for whom standard treatment has failed or no other effective standard treatment available.
• • 4. At least one measurable solid tumor by RECIST 1.1.
• • 5. Subjects assigned to intratumoral injection must have at least one tumor that is suitable for biopsy or intratumoral injection.
• • 6. Life expectancy must be at least 3 months.
• • 7. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
• • 8. Male and female subjects of childbearing potential should take effective contraceptive measures.
• • ① Fertile women and men must agree to use acceptable contraceptive methods from the start of informed consent until at least 6 months after the last administration.
• 9. Laboratory blood test results during the screen period:
• • (1)No blood cell growth factors received within 14 days prior to testing.
• • ① Absolute neutrophil count (ANC)≥1.5×109/L.
• • ② Platelets≥90×109/L. Hemoglobin ≥90 g/L (blood transfusion is allowed to correct). (2) Serum albumin \>30 g/L, total bilirubin \<1.5×ULN, ALT and AST \<2.5×ULN; for subjects with liver metastasis, ALT and AST \<5×ULN; creatinine clearance ≥50 mL/min (Cockcroft-Gault formula) or Cr \<1.5×ULN; (3) Prothrombin time (PT) and activated partial thromboplastin time (aPTT) \<1.5×ULN.
• • 10. Subjects understand the study and willing to sign the informed consent form.
• Exclusion Criteria:
• • 1.Pregnant or breastfeeding women. Subjects known to have a history of abuse of psychiatric drugs, alcoholism, or drug use.
• • 3.Subjects who have previously undergone oncolytic bacteria treatment. 4.Subjects planning to surgery, radiation therapy, or other local treatments for target lesions during the study.
• • 5.Subjects known to be allergic to the study drug or any of its excipients. 6.Subjects allergic or intolerant to antibiotics sensitive to Salmonella, such as amikacin cefpirome, ciprofloxacin,cefotaxime,meropenem.
• • 7.Subjects currently using antibiotics. 8.Subjects who have not recovered fom adverse reactions of prior treatments (treatment-related toxicity grade≤2, except for hair loss, pigmentation, and other tolerable events determined by the investigator).
• • 9.Subjects with active auto-immune diseases or prior diseases with recurrence potential (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroiditis.
• • 10.Subjects with active or uncontrolled infections or unexplained fever≥38.5℃, including but not limited to bacterial infections, tuberculosis, herpes virus infections syphilis infections.
• • 11.Subjects who underwent major surgery within 3 months prior to the first dose of the study drug (except for biopsies for diagnostic purposes).
• • 12.Subjects who have received any anti-tumor treatment within 28 days or 5 half-lives prior to the first dose of the study drug, including chemotherapy, cell therapy, gene therapy, immunotherapy,biological agents, hormone therapy, targeted therapy, tumor drug embolization therapy.
• • 13.Subjects who received radiation therapy within 28 days prior to the first dose of the study drug (except for local radiation therapy for pain relief).
• • 14.Subjects who receive (live attenuated) virus vaccines: within 28 days prior to the first dose of the study drug, or during the study period or within 60 days after the last dose of the study drug.
• • Subjects who have used immunosuppressive drugs within 14 days prior to the first dose of the study drug (i.e., prednisone≥10 mg/day, dexamethasone≥1.5 mg/day), except for corticosteroid nasal sprays and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., prednisone not exceeding 10 mg/day)or equivalent physiologica doses of other corticosteroids.
• • 16. Subjects with known, uncontrolled, or symptomatic active central nervous system conditions.
• 17. Subjects with existing clinical symptoms or pooely controlled heart disease:
• • 1. New York Heart Association (NYHA) class ≥II;
• • 2. Unstable angina;
• • 3. Myocardial infarction within the past year; Subjects with clinically significant supraventricular or ventricular arrhythmias needing treatment or intervention; Medicaion uncontrolled hypertension or hypotension (determined by the investigator); Subjects with valvular heart disease or mitral valve prolapse, aortic valve disease; Severe myocardial diseases. 18.Subjects known to have peripheral thromboembolic vascular diseases, aneurysms, or arterial/venous malformations.
• • 19.Subjects Known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• • 20.Subjects who are positive for Treponema pallidum antibodies, individuals with human immunodeficiency virus (HIV) infection, or known acquired immunodeficiency syndrome (AIDS).
• • 21.Subjects with active hepatitis B (HBsAg positive and/or HBcAb positive with HBV-DNA ≥2000 IU/mL or requiring antiviral treatment), or those who test positive for hepatitis C virus (HCV) antibodies; or subjects co-infection with hepatitis B and C.
• • 22.Other reasons unsuitable for the study as determined by the investigator.