OH2 Injection in Solid Tumors
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ClinicalTrials.gov Identifier: NCT04386967 |
Recruitment Status :
Recruiting
First Posted : May 13, 2020
Last Update Posted : April 4, 2022
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Sponsor:
Binhui Biopharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Binhui Biopharmaceutical Co., Ltd.
Tracking Information | |||||
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First Submitted Date ICMJE | April 13, 2020 | ||||
First Posted Date ICMJE | May 13, 2020 | ||||
Last Update Posted Date | April 4, 2022 | ||||
Actual Study Start Date ICMJE | November 22, 2018 | ||||
Estimated Primary Completion Date | March 13, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | OH2 Injection in Solid Tumors | ||||
Official Title ICMJE | Open and Incremental Phase I Clinical Trial of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) in the Treatment of Advanced Solid Tumors | ||||
Brief Summary | This phase I study evaluates the safety and efficacy of OH2 as single agent or in combination with Keytruda, an anti-PD-1 antibody, in patients with malignant solid tumors (Melanoma). 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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Dose expansion
Dose expansion trial comprises of 2 cohorts. In cohort 1, OH2 injection will be administered at 1x10e7CCID50/mL . In cohort 2, OH2 injection will be administered at 1x10e7CCID50/mL in combination with Keytruda injection, an anti-PD-1 antibody, and the first doses of the two anti-tumor agents will be administered on the same day.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 13, 2023 | ||||
Estimated Primary Completion Date | March 13, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04386967 | ||||
Other Study ID Numbers ICMJE | OH2-I-ST-01 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Binhui Biopharmaceutical Co., Ltd. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Binhui Biopharmaceutical Co., Ltd. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Binhui Biopharmaceutical Co., Ltd. | ||||
Verification Date | April 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |