OH2 Injection in Combination With BS006 Injection for Advanced Solid Tumors

NCT07382531 | Recruiting Phase 1

• 1 other identifier: BS008-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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

  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

  4 weeks from the first administration

• MTD

  If ≥2/6 subjects developed DLT, the previous dose group was MTD

  Through study completion, six months after the last administration of the study drug to the last enrolled subject.

Secondary Outcomes (5)

• ORR/iORR

  Through study completion, six months after the last administration of the study drug to the last enrolled subject.

• DOR/iDOR

  Through study completion, six months after the last administration of the study drug to the last enrolled subject.

• PFS/iPFS

  Through study completion, six months after the last administration of the study drug to the last enrolled subject.

• DCR/iDCR

  Through study completion, six months after the last administration of the study drug to the last enrolled subject.

• OS

  Through study completion, six months after the last administration of the study drug to the last enrolled subject.

Study Arms (1)

OH2+BS006

EXPERIMENTAL

The administration method consists of sequential intratumoral injections of OH2 and BS006 at an equal volume ratio. Administration occurs once every 2 weeks (Q2W) until the investigator determines that the subject no longer derives clinical benefit and exhibits significant clinical disease progression (radiographic progression is not a mandatory criterion for treatment discontinuation), or until the treatment is no longer tolerated, or the clinical trial concludes. For each administration, subjects may receive a maximum of 6 mL each of OH2 Injection and BS006 Injection.

Biological: OH2+BS006

Interventions

OH2+BS006 BIOLOGICAL

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.

OH2+BS006

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Lack of standard effective treatment options, or failure of or relapse after standard treatments.
• 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.
• \. 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.
• \. Patients who have undergone major surgery must be at least 4 weeks post-operation.
• \. 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.
• \. No severe dysfunction of major organs.
• \. 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).
• \. Female subjects and their partners must use effective contraception during treatment and for 3 months after treatment.
• \. Subjects with genital herpes must have completed herpes resolution for at least 3 months.

You may not qualify if:

• \. Concomitant serious medical diseases, including uncontrolled diabetes, severe infections, or active gastrointestinal ulcers.
• \. 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.
• Uncontrolled primary brain tumors or brain metastases.
• \. Bone metastases (except for bone metastases that are stable and controlled after treatment), or the presence of active, clinically symptomatic brain metastases.
• \. 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.
• \. History of immunodeficiency (HIV antibody-positive), or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• \. Uncontrolled psychiatric disorders or infectious diseases. Lesions that do not meet the volume requirements for intratumoral injection.
• \. 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.
• \. Positive HIV test result.
• \. Presence of active tuberculosis infection or other infectious diseases requiring systemic treatment.
• \. Large amounts of pleural effusion or ascites accompanied by clinical symptoms or requiring symptomatic treatment.
• \. Pregnant or breastfeeding women.

Sponsors & Collaborators

• Binhui Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

Central Study Contacts

Juan Zeng

CONTACT

+86 13971257652; zengjuan@binhui-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 2, 2026
• Study Start: September 7, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

CN (1)