Clinical trial NCT03213054: A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Esophageal Cancer
Keywords: esophageal cancer
OBP-301
radiation
Telomelysin
radiotherapy
oncolytic
virotherapy
loco regional
Lead sponsor: Oncolys BioPharma Inc
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Occurrence of Dose Limiting Toxicity
timeFrame: 18 weeks
measure: Incidence rate of adverse event
timeFrame: 18 weeks
Secondary outcomes:
measure: Tumor response in the treatment objected lesion
timeFrame: 18 weeks
measure: Tumor response
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Kashima-shi
country: Japan
facility: Research site
state: Chiba
city: Kita
country: Japan
facility: Research site
state: Okayama
Study officials:
References: