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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OBP-301 + Radiation | Experimental | OBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OBP-301 | Biological | OBP-301 administration on the Day 1, Day 18 and Day 32 |
| |
| 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 |
| 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yira Bermudez, PhD, MBA, RAC | Contact | 5514442576 | y.bermudez@oncolys.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Recruiting | Kashima-shi | Chiba | Japan | ||
| Research site |
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| Label | URL |
|---|---|
| Oncolys BioPharma Homepage | View source |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| Radiation |
| Radiation |
Standard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks |
|
| 18 weeks |
| Recruiting |
| Kita |
| Okayama-ken |
| Japan |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |