Status:
NOT_YET_RECRUITING
First in Human Study of YB1-X7 Injection
Lead Sponsor:
Shanghai Salvectors Biotechnology LTD.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical trial is an open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic, and preliminary efficacy of YB1-X7 injection in subjects with advanced solid...
Detailed Description
YB1-X7 is a genetically engineered attenuated Salmonella enterica strain. It has been further optimized based on the attenuated model of VNP20009 while inserting an anaerobic-targeting enrichment syst...
Eligibility Criteria
Inclusion
- Age ≥18 years, no gender limitatlon
- Subjects with advanced or metastatic solid tumors confirmed by pathological histology.
- Subjects with advanced malignant solid tumors for whom standard treatment has failed or no other effective standard treatment available.
- At least one measurable solid tumor by RECIST 1.1.
- Subjects assigned to intratumoral injection must have at least one tumor that is suitable for biopsy or intratumoral injection.
- Life expectancy must be at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
- 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.
- 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
- Pregnant or breastfeeding women. Subjects known to have a history of abuse of psychiatric drugs, alcoholism, or drug use.
- 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.
- 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.
- 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).
- 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.
- Subjects with active or uncontrolled infections or unexplained fever≥38.5℃, including but not limited to bacterial infections, tuberculosis, herpes virus infections syphilis infections.
- Subjects who underwent major surgery within 3 months prior to the first dose of the study drug (except for biopsies for diagnostic purposes).
- 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.
- 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).
- 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:
- New York Heart Association (NYHA) class ≥II;
- Unstable angina;
- 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.
- Subjects Known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Subjects who are positive for Treponema pallidum antibodies, individuals with human immunodeficiency virus (HIV) infection, or known acquired immunodeficiency syndrome (AIDS).
- 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.
- Other reasons unsuitable for the study as determined by the investigator.
Key Trial Info
Start Date :
March 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06889675
Start Date
March 15 2025
End Date
March 31 2027
Last Update
March 21 2025
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