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

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

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 12 participants
• Allocation: N/A
• 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: March 2019
• Estimated Study Completion Date: June 2019

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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).

Contacts and Locations

Contacts

Contact: Yira Bermudez, PhD, MBA, RAC; 5514442576; y.bermudez@oncolys.com

Locations

Japan

Research site; Recruiting

Kashima-shi, Chiba, Japan

Research site; Recruiting

Kita, Okayama, Japan

Sponsors and Collaborators

Oncolys BioPharma Inc

More Information

Additional Information:

Oncolys BioPharma Homepage 

• Responsible Party: Oncolys BioPharma Inc
• ClinicalTrials.gov Identifier: NCT03213054
• Other Study ID Numbers: TL04001
• First Posted: July 11, 2017
• Last Update Posted: September 26, 2018
• Last Verified: September 2018

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