OH2 Injection in Combination With BS006 Injection for Advanced Solid Tumors

Официальное название

An Open-label, Dose-escalation Phase Ib/II Clinical Trial of Intratumoral Injection of OH2 Injection in Combination With BS006 Injection for the Treatment of Advanced Solid Tumors.

Обзор

BS008-001 is a multicenter, open-label phase Ib /II trial in heavily pre-treated patients with advanced solid tumors. Patients received biweekly sequential intratumoral injections of OH2 (fixed dose: 10⁷ CCID₅₀/mL) followed by BS006 (dose escalation: 10⁶-10⁷ CCID₅₀/mL), with identical volumes being injected at the same lesion. The primary endpoint is safety and tolerability; secondary endpoints included efficacy outcomes assessed by RECIST 1.1/iRECIST.

Вмешательства

• Биопрепарат OH2+BS006
  Patients received biweekly sequential intratumoral injections of OH2 (fixed dose: 10⁷ CCID₅₀/mL) followed by BS006 (dose escalation: 10⁶-10⁷ CCID₅₀/mL), with identical volumes being injected at the same lesion.

Первичные конечные точки

• Incidence of AE (Adverse Event) and SAE (Serious Adverse Event) [Срок оценки: Through study completion, six months after the last administration of the study drug to the last enrolled subject.]
• DLTs (Dose Limiting Toxicity) [Срок оценки: 4 weeks from the first administration]
• MTD [Срок оценки: Through study completion, six months after the last administration of the study drug to the last enrolled subject.]

Вторичные конечные точки (5)

• ORR/iORR [Срок оценки: Through study completion, six months after the last administration of the study drug to the last enrolled subject.]
• DOR/iDOR [Срок оценки: Through study completion, six months after the last administration of the study drug to the last enrolled subject.]
• PFS/iPFS [Срок оценки: Through study completion, six months after the last administration of the study drug to the last enrolled subject.]
• DCR/iDCR [Срок оценки: Through study completion, six months after the last administration of the study drug to the last enrolled subject.]
• OS [Срок оценки: Through study completion, six months after the last administration of the study drug to the last enrolled subject.]

Критерии участия

Критерии включения

• 1\. Patients with unresectable stage III or IV malignant tumors confirmed by pathology and/or cytology; such as malignant melanoma, head and neck tumors, soft tissue sarcoma, liver tumors (primary hepatocellular carcinoma or liver metastases), biliary tract tumors, pancreatic cancer, esophageal cancer, gastric cancer, etc.
• 2\. Lack of standard effective treatment options, or failure of or relapse after standard treatments.
• 3.Male or female patients aged 18-75 years (inclusive); Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; expected survival of more than 3 months.
• 4\. At least 4 weeks have elapsed since completion of prior antitumor therapies (including endocrine therapy, chemotherapy/radiotherapy, and targeted therapy) (except radiotherapy for bone metastases); for patients treated with nitrosoureas or mitomycin, at least 6 weeks since discontinuation; and recovery from prior treatment-related adverse effects to Grade 1 or lower.
• 5\. Patients who have undergone major surgery must be at least 4 weeks post-operation.
• 6\. According to RECIST 1.1 criteria, at least one measurable target lesion is required, with a lesion suitable for intratumoral injection. A measurable tumor lesion is defined as having a longest diameter ≥10 mm with a scan slice thickness ≤5.0 mm; for lymph node lesions, a short-axis diameter ≥15 mm.
• 7\. No severe dysfunction of major organs.
• 8\. Laboratory tests:

• White Blood Cell (WBC) ≥3.0×10⁹/L, Absolute Neutrophil Count (ANC) ≥2.0×10⁹/L, Hemoglobin (Hb) ≥90 g/L; Platelet (PLT) ≥100×10⁹/L; absolute lymphocyte count (ALC)≥0.8×10⁹/L;
• Blood urea nitrogen (BUN) and serum creatinine ≤1.5× the upper limit of normal (ULN);
• Total bilirubin (TBIL) ≤1.5× ULN (for patients with hepatic involvement, TBIL ≤3× ULN);
• Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5× ULN; for patients with liver metastases, ≤5× ULN;
• Normal coagulation function (Prothrombin Time, APTT, and Thrombin Time ≤1.5× ULN).
• 9\. Female subjects and their partners must use effective contraception during treatment and for 3 months after treatment.
• 10\. Subjects with genital herpes must have completed herpes resolution for at least 3 months.
• 11\. Voluntary signing of the informed consent form, with expected good compliance.

Критерии исключения

• 1\. Concomitant serious medical diseases, including uncontrolled diabetes, severe infections, or active gastrointestinal ulcers.
• 2\. Presence of clinically significant cardiovascular or cerebrovascular disease, including:

• Severe or uncontrolled heart disease requiring treatment, congestive heart failure classified as New York Heart Association (NYHA) class III or IV, unstable angina not controlled by medication, a history of myocardial infarction within the past 6 months, Corrected QT Interval (QTc) on Electrocardiogram (ECG) ≥450 ms in males or ≥470 ms in females, or severe arrhythmias requiring drug treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia);
• Placement of a cardiac stent within the past 6 months;
• Inadequately controlled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
• 3.Uncontrolled primary brain tumors or brain metastases.
• 4\. Bone metastases (except for bone metastases that are stable and controlled after treatment), or the presence of active, clinically symptomatic brain metastases.
• 5\. Active autoimmune diseases requiring systemic treatment within the past 2 years (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, etc., such as the use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for renal or pituitary insufficiency) is not considered a systemic treatment.
• 6\. History of immunodeficiency (HIV antibody-positive), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• 7\. Uncontrolled psychiatric disorders or infectious diseases. Lesions that do not meet the volume requirements for intratumoral injection.
• 8\. Patients with active hepatitis B or hepatitis C infection: those who are HBsAg-positive or HBcAb-positive with detectable HBV DNA copies (lower limit of quantification: 500 IU/mL); HBV DNA testing is mandatory at screening for such patients. Patients with a positive anti-HCV antibody test are eligible only if HCV RNA PCR testing is negative.
• 9\. Positive HIV test result.
• 10\. Presence of active tuberculosis infection or other infectious diseases requiring systemic treatment.
• 11\. Large amounts of pleural effusion or ascites accompanied by clinical symptoms or requiring symptomatic treatment.
• 12\. Pregnant or breastfeeding women.
• 13\. Use of, or ongoing treatment with, other investigational drugs or antiviral therapies within 4 weeks prior to treatment, except that patients with chronic hepatitis B receiving continuous treatment may use entecavir, tenofovir disoproxil fumarate, or adefovir dipivoxil.
• 14\. Participation in another clinical study within the past 4 weeks.
• 15\. Known allergy to herpes viruses or any components of the study drug.
• 16\. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongnan Hospital of Wuhan University — Ухань

Идентификаторы

NCT: NCT07382531 · BS008-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗