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A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03213054
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Oncolys BioPharma Inc

Tracking Information
First Submitted Date  ICMJE July 6, 2017
First Posted Date  ICMJE July 11, 2017
Last Update Posted Date September 26, 2018
Actual Study Start Date  ICMJE July 7, 2017
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
  • Occurrence of Dose Limiting Toxicity [ Time Frame: 18 weeks ]
    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 [ Time Frame: 18 weeks ]
    Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03213054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
  • Tumor response in the treatment objected lesion [ Time Frame: 18 weeks ]
    Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.
  • Tumor response [ Time Frame: 18 weeks ]
    Tumor response as the best overall response of the record within 18 weeks from the start of treatment.
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 A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE
  • Biological: OBP-301
    OBP-301 administration on the Day 1, Day 18 and Day 32
  • Radiation: Radiation
    Standard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks
Study Arms  ICMJE Experimental: OBP-301 + Radiation
OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.
Interventions:
  • Biological: OBP-301
  • Radiation: Radiation
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: July 6, 2017)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Patients who have primary tumor or metastatic lesion of histologically or cytologically diagnosed with esophageal carcinoma.
  2. Patients are feasible for injection of OBP-301 into target legion
  3. Patients aged in 20 to 89 years.
  4. Patients with ECOG Performance Status Score ≤ 2.
  5. Patient who have life expectancy longer than 12 weeks.
  6. Patients who are not applicable to standard therapy.
  7. Patients who have adequate organ function.

Key Exclusion Criteria:

  1. Patients who have an active, treatment-required concomitant malignancy.
  2. Patients who had been enrolled within 4 weeks to other clinical trials of unapproved drugs.
  3. Patients who have had chemotherapy within 4 weeks.
  4. Patients who have treatment history of cancer immunotherapy.
  5. Patients who had radiotherapy to treatment targeted lesion.
  6. Patients who have active infection which required systemic treatment.
  7. Patients who are scored III or IV by NYHA (New York Heart Association).
  8. Patients who are judged as inappropriate to this trial by investigator(s).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yira Bermudez, PhD, MBA, RAC 5514442576 y.bermudez@oncolys.com
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03213054
Other Study ID Numbers  ICMJE TL04001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oncolys BioPharma Inc
Study Sponsor  ICMJE Oncolys BioPharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oncolys BioPharma Inc
Verification Date September 2018

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