Search Cancer Clinical Trials
Recruiting
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.
- Cancer
- Melanoma
- Solid Tumor
- Squamous Cell Carcinoma of Head and Neck
- Breast Cancer
- Advanced Solid Tumor
- ONCR-177
- pembrolizumab
Phase 1
Interventional
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
71
May 20, 2020
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Oncorus, Inc.
Oncorus, Inc.
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
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.