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 Tumours or With Liver Metastases of Solid Tumours

Titre officiel

A Phase 1, Open-Label, Multicentre, Dose Escalation and Expansion Study of ONCR-177, an Oncolytic Herpes Simplex Virus for Intratumoural Injection, Alone and in Combination With PD-1 Blockade in Adult Subjects With Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumours or With Liver Metastases of Solid Tumours

Sommaire:

ONCR-177-101 est une étude ouverte de phase 1 multicentrique, d’augmentation et d’expansion de la dose portant sur ONCR-177, un virus oncolytique de l’herpès simplex pour injection intratumorale, seul et en association avec un blocage de PD-1 chez des sujets adultes atteints de tumeurs solides ganglionnaires cutanées, sous-cutanées ou métastatiques avancées ou réfractaires, ou de métastases hépatiques de tumeurs solides. L’objectif de cette étude est de déterminer la dose maximale tolérée (DMT) et la dose recommandée pour la phase 2 (DRP2) ainsi que d’évaluer l’efficacité préliminaire.

Description de l'essai

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

ONCR-177 is an intratumourally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1 (herpes simplex virus type 1) that selectively replicates in tumour tissue. Oncorus Inc. is developing ONCR-177 both as monotherapy and in combination with PD-1 blockade for the treatment of advanced solid tumour malignancies. This first-in-human (FIH) Phase 1 dose escalation and expansion study will determine the intratumoural dose of ONCR-177 as a monotherapy and in combination with pembrolizumab, in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumours or with Liver Metastases of Solid Tumours. This protocol will enroll subjects who have at least one lesion that is visible, palpable or detectable and can be injected, and subjects who have liver metastases of solid tumours. Subjects with any cancer types who are eligible for the trial and have such lesions can be considered for enrollment. Additionally, preliminary evidence for clinical and immunologic activity will be sought to guide ongoing studies and development of ONCR-177 in subjects with cancers that are unmet medical needs. Confirmation of safety of ONCR-177 administration in combination with pembrolizumab will also be evaluated in this study, to enable development as part of combination immunotherapy.

Voir cet essai sur ClinicalTrials.gov