Back to resultsA Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer
Primary Purpose
Esophageal Cancer
Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
OBP-301
Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, OBP-301, radiation, Telomelysin, radiotherapy, oncolytic, virotherapy, loco regional
Eligibility Criteria
Key Inclusion Criteria:
- Patients who have primary tumor or metastatic lesion of histologically or cytologically diagnosed with esophageal carcinoma.
- Patients are feasible for injection of OBP-301 into target legion
- Patients aged in 20 to 89 years.
- Patients with ECOG Performance Status Score ≤ 2.
- Patient who have life expectancy longer than 12 weeks.
- Patients who are not applicable to standard therapy.
- Patients who have adequate organ function.
Key Exclusion Criteria:
- Patients who have an active, treatment-required concomitant malignancy.
- Patients who had been enrolled within 4 weeks to other clinical trials of unapproved drugs.
- Patients who have had chemotherapy within 4 weeks.
- Patients who have treatment history of cancer immunotherapy.
- Patients who had radiotherapy to treatment targeted lesion.
- Patients who have active infection which required systemic treatment.
- Patients who are scored III or IV by NYHA (New York Heart Association).
- Patients who are judged as inappropriate to this trial by investigator(s).
Sites / Locations
- Research siteRecruiting
- Research siteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OBP-301 + Radiation
Arm Description
OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.
Outcomes
Primary Outcome Measures
Occurrence of Dose Limiting Toxicity
Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy
Incidence rate of adverse event
Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy
Secondary Outcome Measures
Tumor response in the treatment objected lesion
Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.
Tumor response
Tumor response as the best overall response of the record within 18 weeks from the start of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03213054
Brief Title
A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer
Official Title
A Phase 1 Study to Evaluate the Safety of OBP-301, Telomelysin in Combination With Radiation Therapy in Patients With Esophageal Cancer Not Applicable for Standard Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2017 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oncolys BioPharma Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase 1 study to evaluate safety and tolerability of Telomelysin (OBP-301) in combination with radiation therapy in patient with esophageal cancer who are not applicable to standard therapy.
Detailed Description
After screening, patients will undergo a combination therapy of OBP-301 with radiation therapy for 6 weeks. At Day 1, Day 18 and Day 32, OBP-301 is directly injected to the location of the lesion. From Day 4, patients receive radiation therapy. Patients will be automatically entered follow-up period for 12 weeks to be observed tolerance and safety.
This study is designated as standard 3 + 3 dose escalation study. The first 3 patients will be evaluated with low-dose of OBP-301 and then the study move onto the high-dose cohort of OBP-301. When the DLT (Dose Limiting Toxicity) is observed, 3 more patients will be enrolled in the dose level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
esophageal cancer, OBP-301, radiation, Telomelysin, radiotherapy, oncolytic, virotherapy, loco regional
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OBP-301 + Radiation
Arm Type
Experimental
Arm Description
OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.
Intervention Type
Biological
Intervention Name(s)
OBP-301
Intervention Description
OBP-301 administration on the Day 1, Day 18 and Day 32
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
Standard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks
Primary Outcome Measure Information:
Title
Occurrence of Dose Limiting Toxicity
Description
Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy
Time Frame
18 weeks
Title
Incidence rate of adverse event
Description
Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Tumor response in the treatment objected lesion
Description
Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.
Time Frame
18 weeks
Title
Tumor response
Description
Tumor response as the best overall response of the record within 18 weeks from the start of treatment.
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Patients who have primary tumor or metastatic lesion of histologically or cytologically diagnosed with esophageal carcinoma.
Patients are feasible for injection of OBP-301 into target legion
Patients aged in 20 to 89 years.
Patients with ECOG Performance Status Score ≤ 2.
Patient who have life expectancy longer than 12 weeks.
Patients who are not applicable to standard therapy.
Patients who have adequate organ function.
Key Exclusion Criteria:
Patients who have an active, treatment-required concomitant malignancy.
Patients who had been enrolled within 4 weeks to other clinical trials of unapproved drugs.
Patients who have had chemotherapy within 4 weeks.
Patients who have treatment history of cancer immunotherapy.
Patients who had radiotherapy to treatment targeted lesion.
Patients who have active infection which required systemic treatment.
Patients who are scored III or IV by NYHA (New York Heart Association).
Patients who are judged as inappropriate to this trial by investigator(s).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yira Bermudez, PhD, MBA, RAC
Phone
5514442576
Email
y.bermudez@oncolys.com
Facility Information:
Facility Name
Research site
City
Kashima-shi
State/Province
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research site
City
Kita
State/Province
Okayama
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.oncolys.com/
Description
Oncolys BioPharma Homepage
Learn more about this trial
A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer
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