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
Breast Cancer
Colon/Rectal Cancer
Melanoma
18 Years and older, Male and Female
ONCR-177-101 (primary)
NCI-2020-02978
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
- Male or female = 18 years of age
- 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
- 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
- Be fully recovered from major surgery and from the acute toxic effects of prior chemotherapy radiotherapy, or immunotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Must have adequate hematologic function in accordance with the study protocol
- Must have adequate hepatic function in accordance with the study protocol
- Must have adequate renal function in accordance with the study protocol
- 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)
- Life expectancy of = 3 months Expansion: •Evaluable or measurable disease, according to Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1 criteria Key
Treatment Sites in Georgia
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