Trials / Terminated
TerminatedNCT04637698
OH2 Oncolytic Viral Therapy in Pancreatic Cancer
Phase Ib/II Study of OH2 Injection, an Oncolytic Type 2 Herpes Simplex Virus Expressing Granulocyte Macrophage Colony-Stimulating Factor, in Pancreatic Cancer
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Binhui Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This phase Ib/II study evaluates the safety and efficacy of OH2 in patients with locally advanced/metastatic pancreatic cancer who have failed first-line standard treatment. 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.
Detailed description
OH2 injection ≤ 4 mL, administered by intratumoral injection of EUS-FNA, administered on the first day of the first cycle, every 3 weeks thereafter, administered on the 1st day of each cycle ± 3 days, continuous administration does not more than 6 treatment cycles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | OH2 injection | Oncolytic Type 2 Herpes Simplex Virus |
Timeline
- Start date
- 2021-02-02
- Primary completion
- 2023-05-04
- Completion
- 2023-05-04
- First posted
- 2020-11-20
- Last updated
- 2023-11-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04637698. Inclusion in this directory is not an endorsement.