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

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Biological: OBP-301; Radiation: Radiation

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
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yira Bermudez, PhD, MBA, RAC; Phone Number: 5514442576; Email: y.bermudez@oncolys.com

Study Locations

• Japan
  • Chiba
    • Kashima-shi, Chiba, Japan
      • Recruiting
      • Research Site
  • Okayama
    • Kita, Okayama, Japan
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 weeks
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	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response in the treatment objected lesion	Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.	18 weeks
Tumor response	Tumor response as the best overall response of the record within 18 weeks from the start of treatment.	18 weeks

Collaborators and Investigators

• Sponsor: Oncolys BioPharma Inc

Publications and helpful links

Helpful Links

• Oncolys BioPharma Homepage

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: radiotherapy; esophageal cancer; virotherapy; radiation; oncolytic; OBP-301; Telomelysin; loco regional
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: TL04001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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