NCT03213054

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

Status unknown Phase 1 Last updated 24 September 2018

What this trial tests

Phase 1 trial testing OBP-301 in Esophageal Cancer in 12 participants. Status unknown.

Timeline

7 July 2017

Primary endpoint
1 March 2019

1 June 2019

Quick facts

Lead sponsor	Oncolys BioPharma Inc
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	7 July 2017
Primary completion	1 March 2019
Estimated completion	1 June 2019
Sites	2 locations across Japan

Drugs / interventions tested

• OBP-301 — full drug profile →
• Radiation

Conditions studied

• Esophageal Cancer — all drugs for Esophageal Cancer →

Sponsor

Oncolys BioPharma Inc

Who can join

Adults 20 to 89, any sex, with Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Oncolytic Viruses for Cancer Therapy: Barriers and Recent Advances.
   Zheng M, Huang J, Tong A, Yang H. · · 2019 · cited 213× · PMID 31872046 · DOI 10.1016/j.omto.2019.10.007
2. Concepts in Oncolytic Adenovirus Therapy.
   Mantwill K, Klein FG, Wang D, Hindupur SV, et al · · 2021 · cited 75× · PMID 34638863 · DOI 10.3390/ijms221910522
3. Designer Oncolytic Adenovirus: Coming of Age.
   Baker AT, Aguirre-Hernández C, Halldén G, Parker AL. · · 2018 · cited 66× · PMID 29904022 · DOI 10.3390/cancers10060201
4. Overexpression of the MRE11-RAD50-NBS1 (MRN) complex in rectal cancer correlates with poor response to neoadjuvant radiotherapy and prognosis.
   Ho V, Chung L, Singh A, Lea V, et al · · 2018 · cited 65× · PMID 30176843 · DOI 10.1186/s12885-018-4776-9
5. Trial Watch: Oncolytic viro-immunotherapy of hematologic and solid tumors.
   Pol JG, Lévesque S, Workenhe ST, Gujar S, et al · · 2018 · cited 61× · PMID 30524901 · DOI 10.1080/2162402x.2018.1503032
6. Expanding the Spectrum of Adenoviral Vectors for Cancer Therapy.
   Gao J, Zhang W, Ehrhardt A. · · 2020 · cited 43× · PMID 32370135 · DOI 10.3390/cancers12051139
7. Oncolytic Adenoviruses: The Cold War against Cancer Finally Turns Hot.
   Oronsky B, Gastman B, Conley AP, Reid C, et al · · 2022 · cited 25× · PMID 36230621 · DOI 10.3390/cancers14194701
8. Oncolytic virotherapy in upper gastrointestinal tract cancers.
   Yokoda R, Nagalo BM, Arora M, Egan JB, et al · · 2017 · cited 17× · PMID 29616200 · DOI 10.2147/ov.s161397