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OH2 Injection in Solid Tumors

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ClinicalTrials.gov Identifier: NCT04386967
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Wuhan Binhui Biotechnology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE April 13, 2020
First Posted Date  ICMJE May 13, 2020
Last Update Posted Date July 21, 2021
Actual Study Start Date  ICMJE March 13, 2020
Estimated Primary Completion Date March 13, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2020)
  • Further evaluation of dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of OH2 in patients with solid tumors [ Time Frame: 12 months ]
  • The dose-limiting toxicity (DLT) of OH2 injection and Keytruda in patients with solid tumors [ Time Frame: 12 months ]
  • The maximum-tolerated dose (MTD) of OH2 injection in combination with Keytruda in patients with solid tumors [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2020)
  • The response rate of patients with solid tumors receiving OH2 injection monotherapy and OH2 injection in combination with Keytruda [ Time Frame: 12 months ]
  • The biodistribution of OH2 injection as determined by the concentration of OH2 in blood, urine and feces of participating patients [ Time Frame: 12 months ]
  • The immunogenicity of OH2 injection as determined by the detection of antibodies in response to OH2 and GM-CSF [ Time Frame: 12 months ]
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Melanoma
Intervention  ICMJE
  • Biological: OH2 injection
    Oncolytic Type 2 Herpes Simplex Virus
  • Drug: Keytruda
    Anti-PD-1 antibody
    Other Name: pembrolizumab
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:
  • Biological: OH2 injection
  • Drug: Keytruda
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 11, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 13, 2022
Estimated Primary Completion Date March 13, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The non-operative stage III or stage IV malignant tumor patients with clear diagnosis by pathology and/ or cytology; breast cancer, gastrointestinal adenocarcinoma, liver cancer, cervical cancer, malignant melanoma, head and neck tumors, Priority inclusion in soft tissue sarcomas (mainly for melanoma patients at the dose extension phase).
  2. The absence of a conventional effective treatment or treatment failure or recurrence by a conventional method.
  3. Male or female patients, aged 18 ≤ 75 years (including boundary value), general physical condition score ECOG 0 ≤ 1, expected survival time more than 3 months.
  4. Prior anti-tumor treatment (including endocrine, chemical/ radiotherapy,targeted therapy) was over 4 weeks (more than 6 weeks of discontinuation using nitroso-and mitomycin-based chemotherapy) and was recovered to grade 1 from the side effects of prior treatment.
  5. Those who have undergone major surgery will have to undergo surgery for four weeks.
  6. There is at least one measurable lesion that is suitable for intratumoral injection. According to RECIST version 1.1, it is determined that at least once the CT or MRI examination shows the tumor lesion, it is possible to measure the tumor focus. The measured tumor focus is defined as the longest diameter ≥ 10 mm and the scanning thickness is not more than 5.0 mm. For lymph node lesions, the short diameter is ≥ 15 mm.
  7. There is no serious dysfunction of the main organs.
  8. (a) WBC≥3.0×109/L,ANC≥2.0×109/L ,PLT≥100×109/L,Hb≥90 g/L; (b) BUN and Scr. were in the upper limit of 1.5 times of the normal value; (c) TBIL≤ 1.5 times the upper limit of the normal value. (d) ALT and AST ≤ 2.5 times the upper limit of normal value; The value of patients with liver metastasis did not exceed 5 times the upper limit of normal value. (e) Coagulation function is normal (PT and APPT are within 1.5 times of the upper limit of normal value).
  9. Female subjects and their spouses received effective contraceptives during and within 3 months of treatment.
  10. Subjects with herpes in the reproductive organs needed three months after the end of herpes.
  11. The informed consent was voluntarily signed and the expected compliance was good.

Exclusion Criteria:

  1. Severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active digestive tract ulcer, abnormal immune function (including, but not limited to, rheumatoid arthritis, lupus erythematosus, Sjogren's syndrome, etc.).
  2. History of primary grape-film melanoma or other malignant tumors in the 3 years prior to treatment. (use of combination drugs only)
  3. Past or present immunodeficiency diseases. (use of combination drugs only)
  4. Treated with PD-1/PD-L1 or PD-L2 monoantigens or inhibitors that have been used or used in the past. (use of combination drugs only)
  5. Autoimmune diseases requiring systemic treatment (e.g. steroids or immunosuppressants) during the first 2 years of treatment, such as autoimmune pneumonia, glomerular nephritis, vasculitis and other symptoms of autoimmune diseases; Except for wind or child asthma. (use of combination drugs only)
  6. Have uncontrolled primary or brain metastatic tumors.
  7. Suffering from uncontrolled mental illness, infectious diseases.
  8. The lesions cannot meet the requirements of injection capacity in the tumor body.
  9. Pregnant or lactating women.
  10. Other experimental therapies or antiviral therapy are used or are being used within 4 weeks of treatment.
  11. Other clinical studies have been taken in the past 4 weeks.
  12. Allergy to herpes virus and drug ingredients.
  13. The researchers believe that there is any reason why the patient is not suitable to participate in this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jun Guo, PH.D 86-010-88140650 guoj307@126.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wuhan Binhui Biotechnology Co., Ltd.
Study Sponsor  ICMJE Wuhan Binhui Biotechnology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wuhan Binhui Biotechnology Co., Ltd.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP