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 Tumors or With Liver Metastases of Solid Tumors

Active:	No
Cancer Type:	Breast Cancer Colon/Rectal Cancer Melanoma	NCT ID:	NCT04348916
Trial Phases:	Phase I	Protocol IDs:	ONCR-177-101 (primary) NCI-2020-02978
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Oncorus, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04348916

Summary

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.

Objectives

ONCR-177 is an intratumorally administered oncolytic immunotherapy comprised of a
genetically engineered HSV-1 (herpes simplex virus type 1) that selectively replicates in
tumor tissue. Oncorus Inc. is developing ONCR-177 both as monotherapy and in combination
with PD-1 blockade for the treatment of advanced solid tumor malignancies. This
first-in-human (FIH) Phase 1 dose escalation and expansion study will determine the
intratumoral 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 tumors or with Liver Metastases of Solid Tumors. 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 tumors. 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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