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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03213054
• Other study ID #: TL04001
• Status: Recruiting
• Phase: Phase 1
• Start date: July 7, 2017
• Est. completion date: June 2019

Study information

• Verified date: September 2018
• Source: Oncolys BioPharma Inc
• Contact: Yira Bermudez, PhD, MBA, RAC
• Phone: 5514442576
• Email: y.bermudez[@]oncolys.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 89 Years

Eligibility

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).

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Research site	Kashima-shi	Chiba
Japan	Research site	Kita	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
Oncolys BioPharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Tumor response in the treatment objected lesion	Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.	18 weeks
Secondary	Tumor response	Tumor response as the best overall response of the record within 18 weeks from the start of treatment.	18 weeks

External Links

•   Oncolys BioPharma Homepage