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Protocol # 20-135

Status

Recruiting

Description

ONCR-177-101 is a phase 1, open-label, multi-center, dose escalation and expansion study of ONCR-177, an oncolytic Herpes Simplex Virus for intratumoral injection, 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. The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

Condition

  • Cancer
  • Melanoma
  • Solid Tumor
  • Squamous Cell Carcinoma of Head and Neck
  • Breast Cancer
  • Advanced Solid Tumor
  • Triple Negative Breast Cancer
  • Colorectal Carcinoma
  • Non-melanoma Skin Cancer
  • Liver Metastases

Interventions

  • ONCR-177
  • pembrolizumab

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Percentage of Dose-Limiting Toxicities (DLTs)
  • Percentage of Adverse Events (AEs)
  • Percentage of Serious Adverse Events (SAEs)
  • Maximum Tolerated Dose (MTD) of ONCR-177
  • Recommended Phase 2 Dose (RP2D) of ONCR-177

Secondary Outcome:

  • Percentage of Objective Response Rate (ORR)
  • Durable Response Rate (DRR)
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Incidence and rate of detection of ONCR-177
  • Changes in the level of HSV-1 antibodies compared to baseline

Enrollment

132

Study Start Date

May 20, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Oncorus, Inc.

Source

Oncorus, Inc.

Official title

A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of ONCR-177, an Oncolytic Herpes Simplex Virus for Intratumoral Injection, 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 Identifier

NCT04348916

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.