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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 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

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,908 Previous Clinical Trials
5,066,621 Total Patients Enrolled
Oncorus, Inc.Lead Sponsor
John Goldberg, MDStudy DirectorOncorus, Inc.
~13 spots leftby Jun 2025
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