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

Phase 1

• Conditions: Esophageal Cancer
• Interventions: Biological: OBP-301; Radiation: Radiation

• Registration Number: NCT03213054
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-06
• Study Start: 2017-07-07
• Study First Posted: 2017-07-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-26
• Primary Completion: 2019-03
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OBP-301 + Radiation	OBP-301	OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.
OBP-301 + Radiation	Radiation	OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Incidence rate of adverse event	18 weeks	Incidence rate of adverse event for study period to see safety and tolerability of OBP-301 combined with radiation therapy
Occurrence of Dose Limiting Toxicity	18 weeks	Occurrence of Dose Limiting Toxicity for study period to see safety and tolerability of OBP-301 combined with radiation therapy

Secondary Outcome Measures

Name	Time	Method
Tumor response in the treatment objected lesion	18 weeks	Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.
Tumor response	18 weeks	Tumor response as the best overall response of the record within 18 weeks from the start of treatment.

Trial Locations

Locations (1)

Research site; 🇯🇵 Kita, Okayama, Japan