Esophageal CancerPhase 1NCT03213054
A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer
A Phase 1 study testing OBP-301 and Radiation in people with Esophageal Cancer, run by Oncolys BioPharma Inc at 2 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- OBP-301 and Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesJapan
- Study dates
- 7 Jul 2017to Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have primary tumor or metastatic lesion of histologically or cytologically diagnosed with esophageal carcinoma.
- Patients are feasible for injection of OBP-301 into target legion
- Patients aged in 20 to 89 years.
- Patients with ECOG Performance Status Score ≤ 2.
- Patient who have life expectancy longer than 12 weeks.
- Patients who are not applicable to standard therapy.
- Patients who have adequate organ function.
Who cannot join
- Patients who have an active, treatment-required concomitant malignancy.
- Patients who had been enrolled within 4 weeks to other clinical trials of unapproved drugs.
- Patients who have had chemotherapy within 4 weeks.
- Patients who have treatment history of cancer immunotherapy.
- Patients who had radiotherapy to treatment targeted lesion.
- Patients who have active infection which required systemic treatment.
- Patients who are scored III or IV by NYHA (New York Heart Association).
- Patients who are judged as inappropriate to this trial by investigator(s).
Trial locations and contacts
2 sites in 1 country.
Japan2 sites, 2 recruiting
- Recruiting
Research site
Kashima-shi, Chiba
- Recruiting
Research site
Kita, Okayama-ken
About this study
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
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.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- OBP-301, Radiation
- Keywords
- esophageal cancer, OBP-301, radiation, Telomelysin, radiotherapy, oncolytic, virotherapy, loco regional
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBP-301Biological
OBP-301 administration on the Day 1, Day 18 and Day 32
RadiationRadiation
Standard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: OBP-301; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 18 weeks
Secondary outcomes (2)
Tumor response in the treatment objected lesion
Tumor response in the treatment objected lesion within 18 weeks from the start of treatment.
Measured: 18 weeks
Tumor response
Tumor response as the best overall response of the record within 18 weeks from the start of treatment.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start7 Jul 2017
- Primary completionMar 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncolys BioPharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213054
- Sponsor's protocol ID
- TL04001
- Status last verified
- Sep 2018
- First submitted
- 6 Jul 2017
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03213054
- Acronym / sponsor ID
- TL04001
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer, OBP-301, radiation, Telomelysin, radiotherapy, oncolytic, virotherapy, loco regional
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Oncolys BioPharma IncIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OBP-301 + Radiation | Experimental | Biological: OBP-301, Radiation: RadiationOBP-301 administration on the Day 1, Day 18 and Day 32 with standard course of radiation(total 60 Gy) for 6 weeks. |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have primary tumor or metastatic lesion of histologically or cytologically diagnosed with esophageal carcinoma.
- Patients are feasible for injection of OBP-301 into target legion
- Patients aged in 20 to 89 years.
- Patients with ECOG Performance Status Score ≤ 2.
- Patient who have life expectancy longer than 12 weeks.
Key exclusion criteria (8 listed)
- Patients who have an active, treatment-required concomitant malignancy.
- Patients who had been enrolled within 4 weeks to other clinical trials of unapproved drugs.
- Patients who have had chemotherapy within 4 weeks.
- Patients who have treatment history of cancer immunotherapy.
- Patients who had radiotherapy to treatment targeted lesion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBP-301OBP-301 administration on the Day 1, Day 18 and Day 32 | Biological | OBP-301 + Radiation |
| RadiationStandard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks | Radiation | OBP-301 + Radiation |
Primary outcome
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
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
2 secondary outcomes
Tumor response in the treatment objected lesion
Time frame: 18 weeks
Tumor response
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Oncolys BioPharma HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OBP-301 and Radiation in people with Esophageal Cancer, run by Oncolys BioPharma Inc at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yira Bermudez, PhD, MBA, RAC (5514442576, y.bermudez@oncolys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Dose Limiting Toxicity (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.