OH2 Injection in Combination With BS006 Injection for Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBinhui Biopharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
1. Concomitant serious medical diseases, including uncontrolled diabetes, severe infections, or active gastrointestinal ulcers.
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.
Trial design
Treatments tested in this trial
- OH2+BS006
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov