UnknownPhase 1

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

Japan12 participantsStarted 2017-07-07

Plain-language 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.

Who can participate

Age range20 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).

What they're measuring

Occurrence of Dose Limiting Toxicity

Timeframe: 18 weeks

Incidence rate of adverse event

Timeframe: 18 weeks

Trial details

NCT IDNCT03213054

SponsorOncolys BioPharma Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03

Contact for this trial

Yira Bermudez, PhD, MBA, RAC

5514442576 y.bermudez@oncolys.com

View on ClinicalTrials.gov More Esophageal Cancer trials