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OH2 Alone or in Combination With Keytruda in Advanced Solid Tumors
NCT04386967Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2018
- Primary completion
- Jun 2026
- Countries
- 1
- Modality
- Gene Editing, Prophylactic Vaccines, Gene Silencing
- Drugs
- OH2
- Conditions
- solid tumormelanoma
01
Overview
Phase 2, open-label trial of OH2 in solid tumor and melanoma (2 cohorts), sponsored by Wuhan Binhui Biopharmaceutical Co., Ltd. Primary endpoints: Dose-Limiting Toxicity of OH2 at 12 months, Maximum-Tolerated Dose of OH2 at 12 months and 2 more. Started Nov 2018; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Cohort 1: OH2 Monotherapy
OH2 injection administered at 1x10e7 CCID50/mL.
Cohort 2: OH2 + Keytruda
OH2 injection administered at 1x10e7 CCID50/mL in combination with Keytruda (pembrolizumab).
03
Who it enrols
Adult patients (18-75 years) with advanced solid tumors (priority for melanoma) who have failed conventional treatments, have an ECOG score of 0-1, life expectancy >3 months, and at least one measurable lesion suitable for intratumoral injection. Excludes patients with severe medical conditions, uncontrolled brain metastases, autoimmune diseases, or prior treatment with PD-1/PD-L1 inhibitors (for the combination cohort).
04
Endpoints
Primary
Dose-Limiting Toxicity of OH2
Maximum-Tolerated Dose of OH2
Dose-Limiting Toxicity of OH2 and Keytruda
Maximum-Tolerated Dose of OH2 and Keytruda
Secondary
Objective Response Rate
Biodistribution of OH2
Immunogenicity of OH2
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