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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

Status
Active
Cancer Type
Breast Cancer
Colon/Rectal Cancer
Melanoma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04348916
Protocol IDs
ONCR-177-101 (primary)
NCI-2020-02978
Study Sponsor
Oncorus, Inc.

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.

Eligibility

  1. Male or female = 18 years of age
  2. Solid tumor cancer with at least one injectable cutaneous, subcutaneous or nodal tumor OR at least one injectable liver metastasis that can be visualized and injected under radiologic guidance
  3. Have advanced or metastatic solid tumors who are refractory to, ineligible for, relapsed from and/or intolerant of standard of care treatment or must have a disease for which no standard of care exists
  4. Be fully recovered from major surgery and from the acute toxic effects of prior chemotherapy radiotherapy, or immunotherapy
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
  6. Must have adequate hematologic function in accordance with the study protocol
  7. Must have adequate hepatic function in accordance with the study protocol
  8. Must have adequate renal function in accordance with the study protocol
  9. Female subjects of reproductive potential must have a negative serum pregnancy test during Screening and a serum or urine pregnancy test must be re-confirmed as negative no more than 72 hours before starting study treatment. Females of reproductive potential as well as fertile men with partners who are female of reproductive potential must agree to abstain from sexual intercourse or to use 2 effective forms of contraception (including at least 1 barrier form) from the time of giving informed consent, during the study, and for 6 months (both females and males) following the last dose of study drug(s)
  10. Life expectancy of = 3 months

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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