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Virus Therapy

ONCR-177 for Oral Squamous Cell Carcinoma

Phase 1

Waitlist Available

Research Sponsored by Oncorus, Inc.

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 40 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that uses a virus to kill cancer cells. The virus is injected into the tumor, and the dose is increased until the maximum tolerated dose is found. The trial is also testing whether this treatment is more effective when combined with another cancer treatment.

Eligible Conditions

Oral Squamous Cell Carcinoma
Colorectal Cancer
Cancer
Melanoma
Squamous Cell Carcinoma
Breast Cancer
Non-melanoma Skin Cancer
Liver Metastases
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 40 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~40 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum Tolerated Dose (MTD) of ONCR-177

Percentage of Adverse Events (AEs)

Percentage of Dose-Limiting Toxicities (DLTs)

+2 more

Secondary outcome measures

Changes in the level of HSV-1 antibodies compared to baseline

Durable Response Rate (DRR)

Incidence and rate of detection of ONCR-177

+3 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Dose expansion of ONCR-177 in subjects with surface lesionsExperimental Treatment1 Intervention

Dose expansion of ONCR-177 intratumoral injections alone at the recommended phase 2 dose (RP2D) in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors

Group II: Dose expansion of ONCR-177 by intratumoral injection in subjects with liver metastasesExperimental Treatment1 Intervention

Dose expansion of ONCR-177 intratumoral injections alone at the recommended phase 2 dose (RP2D) in subjects with advanced and/or refractory solid tumor cancer with liver metastases

Group III: Dose expansion of ONCR-177 and pembrolizumab in subjects with surface lesionsExperimental Treatment2 Interventions

Dose expansion of ONCR-177 intratumoral injections at the RP2D in combination with pembrolizumab in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors

Group IV: Dose expansion of ONCR-177 and pembrolizumab in subjects with liver metastasesExperimental Treatment2 Interventions

Dose expansion of ONCR-177 intratumoral injections at the RP2D in combination with pembrolizumab in subjects with advanced and/or refractory solid tumor cancer with liver metastases

Group V: Dose escalation of ONCR-177 by intratumoral injection in subjects with surface lesionsExperimental Treatment1 Intervention

Dose escalation of ONCR-177 intratumoral injections alone in four cohorts in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors

Group VI: Dose escalation of ONCR-177 by intratumoral injection in subjects with liver metastasesExperimental Treatment1 Intervention

Dose escalation of ONCR-177 intratumoral injections alone in four cohorts in subjects with advanced and/or refractory solid tumor cancer with liver metastases

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,054,938 Total Patients Enrolled

Oncorus, Inc.Lead Sponsor

John Goldberg, MDStudy DirectorOncorus, Inc.

Frequently Asked Questions

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

Has ONCR-177 been granted permission for use by the FDA?

"Our team has rated the safety of ONCR-177 to be a 1 due to there being limited data attesting both its efficacy and security, as this is only in the initial stages of trial."

Answered by AI

Are people still able to join this research endeavor?

"Affirmative. Clinicaltrials.gov records that this medical research, which was initially posted on May 20th 2020, is currently looking for participants. 132 clinical trial members need to be recruited from 11 different sites across the country."

Answered by AI

How many sites offer access to this research study?

"This research is currently enrolling participants at Sarah Cannon Research Institute, Roswell Park Cancer Institute and University Health Network. Additionally, 11 other sites are accepting patients for this trial."

Answered by AI

What is the current enrollment cap for this research project?

"This medical study requires 132 patients that meet the pre-determined qualifications to sign up. The Sarah Cannon Research Institute at HealthONE in Denver, Colorado and Roswell Park Cancer Institute are two of the locations recruiting participants for this clinical trial."

Answered by AI

Has ONCR-177 been a focus of any other research efforts?

"Currently, there are 961 active trials for ONCR-177 with 122 in the final phase. Although Houston is a hotspot of these studies, they can be found at 35 742 locations across the world."

Answered by AI

What maladies has ONCR-177 been found to ameliorate?

"ONCR-177 is primarily prescribed for malignant neoplasms, yet it has also been found to be beneficial in treating conditions such as unresectable melanoma and microsatellite instability high disease that progresses despite chemotherapy."

Answered by AI

What is the primary objective of this trial?

"The main outcome of the trial, measured between Day 1 and 30 days following the last dose administered, is to identify the Maximum Tolerated Dose (MTD) of ONCR-177. Additionally, researchers will be assessing Percentage Objective Response Rate (ORR), Progression Free Survival (PFS) duration among patients in addition to any changes observed in HSV-1 antibodies levels compared with baseline measures."

Answered by AI

Recent research and studies

Cancer Immunology ResearchJournal

ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity

Haines, Brian B., Agnieszka Denslow, Peter Grzesik, Jennifer S. Lee, Terry Farkaly, Jacqueline Hewett, Daniel Wambua, et al.. 2021. “ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity”. Cancer Immunology Research. American Association for Cancer Research (AACR). doi:10.1158/2326-6066.cir-20-0609.

clinicaltrials.govStudy

Study of ONCR-177 Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors

2020. "Study of ONCR-177 Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors or With Liver Metastases of Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04348916.