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Trial record 21 of 385 for:    Recruiting, Not yet recruiting, Available Studies | "Esophageal Neoplasms"

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 : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Oncolys BioPharma Inc

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Biological: OBP-301 Radiation: Radiation Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. Tumor response [ Time Frame: 18 weeks ]
    Tumor response as the best overall response of the record within 18 weeks from the start of treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213054


Contacts
Contact: Oncolys BioPharma 03-5472-1578 nakamura@oncolys.com

Locations
Japan
Research site Recruiting
Kashima-shi, Chiba, Japan
Research site Recruiting
Kita, Okayama, Japan
Sponsors and Collaborators
Oncolys BioPharma Inc

Additional Information:
Responsible Party: Oncolys BioPharma Inc
ClinicalTrials.gov Identifier: NCT03213054     History of Changes
Other Study ID Numbers: TL04001
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Oncolys BioPharma Inc:
esophageal cancer
OBP-301
radiation
Telomelysin
radiotherapy
oncolytic
virotherapy
loco regional

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases