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Virus Therapy

Telomelysin for Esophageal Cancer

Phase 2

Waitlist Available

Led By Manish Shah, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

Study Summary

This trial is testing a new drug, OBP-301, to see if it can help treat stomach and esophageal cancer that has gotten worse despite other treatments.

Eligible Conditions

Esophageal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall response rate, as assessed by radiographic imaging

Secondary outcome measures

Disease control rate, as assessed by radiographic imaging

Duration of response, as assessed by radiographic imaging

Overall survival, as assessed by survival

+1 more

Other outcome measures

Flow Cytometry

Change from baseline in T-cell response, as measured by TCR-sequencing of tumor biopsies

Change from baseline in tumor-immune microenvironment, as measured by bulk RNA sequencing and single-cell RNA sequencing.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Telomelysin (OBP-301)Experimental Treatment1 Intervention

All patients will receive Telomelysin (OBP-301) at 2x10^12 viral particles (VP)/ tumor injection administered every two weeks x 4 injections as well as standard dose pembrolizumab 200 mg IV every 3 weeks. The tumor will be injected with OBP-301 four times (d1, d15, d29, d43). The preference is to inject the primary tumor endoscopically. Metastatic lesions may be injected on a case-by-case basis after discussion with the PI (Shah).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Telomelysin

2019

Completed Phase 2

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,535 Total Patients Enrolled

Oncolys BioPharma IncIndustry Sponsor

7 Previous Clinical Trials

101 Total Patients Enrolled

Manish Shah, MDPrincipal InvestigatorWeill Medical College of Cornell University

6 Previous Clinical Trials

390 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How potentially hazardous is Telomelysin for individuals receiving treatment?

"After assessing the safety profile of Telomelysin, our team at Power has assigned it a rating of 2. This is because Phase 2 trials have only provided limited evidence in regards to its efficacy and lack data concerning its hazard potential."

Answered by AI

How many participants are actively engaged in this clinical endeavor?

"Oncolys BioPharma Inc's clinical trial necessitates 41 participants that adhere to the set inclusion criteria. The study will take place at well-known medical centres including Dana-Farber Cancer Institute in Boston, Massachusetts and University of Pennsylvania in Philadelphia, Pennsylvania."

Answered by AI

Is this trial open to enrollment of participants at present?

"Indeed, clinicaltrials.gov data indicates that the study is now recruiting participants; it was initially published on May 9th 2019 and last revised April 29th 2022. The medical trial seeks to enrol 41 patients from 4 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 Study of Telomelysin (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma

2019. "Phase 2 Study of Telomelysin (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03921021.