OH2 Injection in Solid Tumors

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.

Trial Details

NCT ID
NCT04386967
Phase
PHASE1 / PHASE2
Sponsor
Binhui Biopharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • OH2 injection
  • Keytruda
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • The non-operative stage III or stage IV malignant tumor patients with clear diagnosis by pathology and/ or cytology; breast cancer, gastrointestina…
  • The absence of a conventional effective treatment or treatment failure or recurrence by a conventional method.
  • Male or female patients, aged 18 ≤ 75 years (including boundary value), general physical condition score ECOG 0 ≤ 1, expected survival time more th…
  • Prior anti-tumor treatment (including endocrine, chemical/ radiotherapy,targeted therapy) was over 4 weeks (more than 6 weeks of discontinuation us…

For full eligibility, visit ClinicalTrials.gov.

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