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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
OH2+BS006
Biological/VaccinePatients 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: OH2+BS006Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of AE (Adverse Event) and SAE (Serious Adverse Event)
Toxic reactions according to the NCI-CTCAE 5.0 grading standard that occur within 3 weeks from the first administration, are judged to be drug-related by the investigator, and meet the non-hematological toxicity and hematological toxicity conditions specified in the clinical protocol
Time frame
Through study completion, six months after the last administration of the study drug to the last enrolled subject.2
DLTs (Dose Limiting Toxicity)
Toxic reactions according to the NCI-CTCAE 5.0 grading standard that occur within 4 weeks from the first administration, are judged to be drug-related by the investigator, and meet the non-hematological toxicity and hematological toxicity conditions specified in the clinical protocol
Time frame
4 weeks from the first administration3
MTD
If ≥2/6 subjects developed DLT, the previous dose group was MTD
Time frame
Through study completion, six months after the last administration of the study drug to the last enrolled subject.Secondary outcomes
1
ORR/iORR
Tumor response will be assessed according to RECIST 1.1 and iRECIST criteria. Descriptive statistics will be used to calculate the number and proportion of subjects achieving objective response (CR/iCR + PR/iPR) at each evaluation time point.
Time frame
Through study completion, six months after the last administration of the study drug to the last enrolled subject.2
DOR/iDOR
The Kaplan-Meier method will be used to estimate the median duration of response (DoR).
Time frame
Through study completion, six months after the last administration of the study drug to the last enrolled subject.3
PFS/iPFS
The Kaplan-Meier method will be used to estimate the median progression-free survival.
Time frame
Through study completion, six months after the last administration of the study drug to the last enrolled subject.4
DCR/iDCR
umor assessments will be performed according to RECIST 1.1 and iRECIST criteria. Descriptive statistics will be used to calculate the number and proportion of subjects achieving complete response (CR/iCR), partial response (PR/iPR), and stable disease (SD/iSD) at each assessment time point.
Time frame
Through study completion, six months after the last administration of the study drug to the last enrolled subject.Sponsors and contacts
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Source ClinicalTrials.gov