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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. 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

Interventions

  • ONCR-177
  • pembrolizumab

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Percentage of Subjects with Dose-Limiting Toxicities (DLTs) During the First 28 Days of Treatment
  • Percentage of Subjects with Adverse Events and Serious Adverse Events

Secondary Outcome:

  • Objective Response Rate (ORR), based on RECIST v1.1, as well as Durable Response Rate (DRR) (continuous CR or PR ≥6 months), Progression Free Survival (PFS), and Overall Survival (OS)
  • Incidence of ONCR-177 detection
  • Changes in the level of anti-HSV-1 antibodies compared to baseline

Enrollment

71

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

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.