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
NCT04348916 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2023-06-08
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.
Conditions
- Cancer
- Melanoma
- Solid Tumor
- Squamous Cell Carcinoma of Head and Neck
- Breast Cancer
- Advanced Solid Tumor
- Triple Negative Breast Cancer
- Colorectal Carcinoma
- Non-melanoma Skin Cancer
- Liver Metastases
Interventions
- BIOLOGICAL
-
ONCR-177
Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1
- BIOLOGICAL
-
Anti-PD-1 monoclonal antibody
Sponsors & Collaborators
- collaborator INDUSTRY
-
Oncorus, Inc.
lead INDUSTRY
Principal Investigators
-
John Goldberg, MD · Oncorus, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-20
- Primary Completion
- 2023-05-31
- Completion
- 2023-05-31
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
More Related Trials
-
A Phase 1 Study of OMP-305B83 in Subjects With Solid Tumors
NCT02298387 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Intratumoral/Intralesional Administration of V938 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic or Recurrent Malignancies (V938-001)
NCT04135352 ·Status: TERMINATED ·Phase: PHASE1
-
oHSV2-PD-L1/CD3-BsAb Administered Via Intratumoral Injection
NCT05938296 ·Status: SUSPENDED ·Phase: PHASE1
-
Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression
NCT03872206 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Relapsed or Refractory Solid Tumors
NCT05361954 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Pharmacokinetic and Safety Study of MRX-2843 in Adults With Relapsed/Refractory Advanced and/or Metastatic Solid Tumors
NCT03510104 ·Status: COMPLETED ·Phase: PHASE1
-
Study of SRF617 in Patients With Advanced Solid Tumors
NCT04336098 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of ARQ 171 in Patients With Advanced Solid Tumors
NCT00398840 ·Status: TERMINATED ·Phase: PHASE1
-
ARQ 197 in Subjects With Metastatic Solid Tumors
NCT00302172 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors
NCT01277146 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.
NCT06022029 ·Status: RECRUITING ·Phase: PHASE1
-
AO-176 in Multiple Solid Tumor Malignancies
NCT03834948 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of LP-184 in Patients With Advanced Solid Tumors
NCT05933265 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase 1 Dose Escalation Study of OMP-21M18 in Subjects With Solid Tumors
NCT00744562 ·Status: COMPLETED ·Phase: PHASE1
-
Talimogene Laherparepvec in Treating Patients With Non-Muscle Invasive Bladder Transitional Cell Carcinoma
NCT03430687 ·Status: WITHDRAWN ·Phase: PHASE1
-
Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors
NCT03634982 ·Status: UNKNOWN ·Phase: PHASE1
-
A Phase 1 Study Evaluating CB-5083 in Subjects With Advanced Solid Tumors
NCT02243917 ·Status: TERMINATED ·Phase: PHASE1
-
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)
NCT05853367 ·Status: RECRUITING ·Phase: PHASE1
-
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
NCT04198766 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors
NCT06311578 ·Status: RECRUITING ·Phase: PHASE1
-
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
NCT05858736 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety, Tolerability, and Pharmacokinetics of Onartuzumab Combined With Vemurafenib and/or Cobimetinib in Cancer Patients
NCT01974258 ·Status: WITHDRAWN ·Phase: PHASE1
-
A Dose Escalation Study of OMP-18R5 in Subjects With Solid Tumors
NCT01345201 ·Status: COMPLETED ·Phase: PHASE1
-
A Dose Escalation/Expansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors
NCT05716295 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers
NCT02178722 ·Status: COMPLETED ·Phase: PHASE1/PHASE2