TerminatedPhase 2

OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer

Stopped: Strategy adjustment

China4 participantsStarted 2022-05-25

Plain-language summary

This Ⅱ study evaluates the safety and efficacy of intratumoral injection of OH2 in locally advanced or metastatic bladder cancer. OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Agree to sign informed consent, willing to follow the study procedures.
✓. Age 18 \~ 75 years old (including boundary value), male or female.
✓. ECOG 0-1.
✓. Histologically or cytologically confirmed advanced bladder cancer，relapsed and metastasized after radiotherapy or immunotherapy.
✓. Life expectancy \>12 weeks.
✓. Agree to provide last surgical specimens (including paraffin blocks, paraffin embedded sections, etc.).
✓. At least 6 weeks after previous anti-tumor treatment (radiotherapy, chemotherapy and immunotherapy) and the first administration of this trial.
✓. Appropriate organ function and hematopoietic function: neutrophil count (neut ≥ 1.5 × 109/L； White blood cell count (WBC) ≥ 3.0 × 109/L； Platelet count ≥ 100 × 109/L； Hemoglobin ≥ 90g / L; Serum creatinine ≤ 1.5 times the upper limit of normal value (ULN); AST and alt ≤ 2.5 times ULN; Serum total bilirubin ≤ 1.5 times ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN (except for patients undergoing anticoagulant therapy).

Exclusion criteria

What they're measuring

Objective Response Rate

Timeframe: 2 years

Trial details

NCT IDNCT05248789

SponsorBinhui Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-28

View on ClinicalTrials.gov More Advanced Bladder Carcinoma trials