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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGIncidence 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.
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 administration
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.
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.
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.
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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.
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.
OS
The Kaplan-Meier method will be used to estimate the median overall survival (OS).
Time frame: Through study completion, six months after the last administration of the study drug to the last enrolled subject.