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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 2.5 years
Awards & highlights

Summary

This trial tests a combination of a virus (OBP-301) that kills cancer cells and a drug (pembrolizumab) that helps the immune system fight cancer. It targets patients with advanced stomach and esophagus cancer who haven't responded to other treatments. Pembrolizumab has demonstrated activity in previously treated patients with various cancers, including gastric and esophageal cancers.

Eligible Conditions
  • Esophageal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Response Rate, as Assessed by Radiographic Imaging
Secondary study objectives
Disease Control Rate, as Assessed by Radiographic Imaging
Duration of Response, as Assessed by Radiographic Imaging
Overall Survival Rate, as Assessed by Survival
+1 more
Other study objectives
Change From Baseline in Immune Infiltrate by Multi-parameter 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.

Side effects data

From 2023 Phase 2 trial • 17 Patients • NCT03921021
47%
Anorexia
47%
Generalized muscle weakness
41%
Fatigue
35%
Vomiting
29%
Fever
29%
Nausea
24%
Abdominal pain
24%
Chills
18%
Other- Shortness of Breath
18%
Weight loss
18%
Anemia
18%
Dyspnea
18%
Diarrhea
18%
Dehydration
18%
Dysphagia
12%
Other - Gastrointestinal disorder (Gastrointestinal bleed)
12%
Abdominal distension
12%
Other: Muscle weakness
12%
Alkaline phosphatase increased
12%
Constipation
12%
Other (Hyponatremia)
12%
Back pain
12%
Aspartate aminotransferase increased
12%
Wheezing
12%
Edema limbs
12%
Confusion
6%
Hypoxia
6%
Pericardial Tamponade
6%
Acute coronary syndrome
6%
Others - Eye disorders (Intermittent Vision fogginess and Left-sided eye lid lag)
6%
Other (Rectal bleeding)
6%
Other (Delayed Speech and Ill-appearing )
6%
Other (Body Aches)
6%
Gastroesophageal reflux disease
6%
Other (Small pustule on scrotum)
6%
Hypertension
6%
Other (Left flank pain)
6%
Rash acneiform
6%
Other - Gastrointestinal disorder (Dry heaving)
6%
Muscle weakness left-sided
6%
Anxiety
6%
Sepsis
6%
Flu like symptoms
6%
Other (Cranial face deficit and Facial asymmetry)
6%
Other (Slow behavior and Distress)
6%
Hematuria
6%
Other: Type 1 Diabetes Mellitus
6%
Upper gastrointestinal hemorrhage
6%
Other: Gastrointestinal Bleed
6%
Bloating
6%
Hyponatremia
6%
Sinus tachycardia
6%
Other - Gastrointestinal disorder (Small bowel obstruction)
6%
Sinusitis
6%
Myalgia
6%
Other (Pain to left ribs)
6%
Flatulence
6%
Other - Gastrointestinal disorder (Epigastric pain and Abdominal Mass)
6%
Dry Eye
6%
Other - Ear and labyrinth disorders (Decreased hearing)
6%
Other - Gastrointestinal disorder (Dark stool)
6%
Other - Gastrointestinal disorder (Abdominal tenderness)
6%
Other - Gastrointestinal disorder (Belching)
6%
Other - Gastrointestinal disorder (Melena)
6%
Other (Cold Sore, Edema and Localized pain near injection site)
6%
Other - Gastrointestinal disorder (Balance Issues)
6%
Other (lightheadedness)
6%
Alanine aminotransferase increased
6%
Blood bilirubin increased
6%
Arthralgia
6%
Bone pain
6%
Pleural effusion
6%
Peripheral sensory neuropathy
6%
Tremor
6%
Hallucinations
6%
Other (Nervousness)
6%
Rash maculo-papular
6%
Hypotension
6%
Esophagitis
6%
Other (Cervical Adenopathy)
6%
Creatinine increased
6%
Other (Blood urea nitrogen increased)
6%
Dizziness
6%
Other (Pallor)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Telomelysin (OBP-301)

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

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,077 Previous Clinical Trials
1,320,650 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
393 Total Patients Enrolled
~3 spots leftby Sep 2025
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