CancerPhase 1NCT04348916
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
A Phase 1 study testing ONCR-177 and pembrolizumab in people with Cancer and Melanoma, run by Oncorus, Inc. at 11 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Melanoma, Solid Tumor
- What is being tested?
- ONCR-177 and pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 20 May 2020to 31 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Subjects on current antiviral treatment for herpes virus infections
- Requires chronic or intermittent treatment with systemic antivirals
- Any systemic anti-cancer treatment (including investigational agents) within 4 weeks prior to the first dose of study drug
- Has received prior radiotherapy within 2 weeks of start of study treatment
- Myelosuppressive chemotherapy within 4 weeks of study treatment
- Prior checkpoint inhibitor therapy administered within 4 weeks of study treatment
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- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Has not fully recovered from any effects of major surgery or not free of significant detectable infection
- Other active malignancy within the previous 3 years of first dose of study treatment
- Has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis
- Have had significant active cardiac disease within 6 months prior to the start of study treatment
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has received a live vaccine within 30 days prior to the first dose of study drug
- Are pregnant or breastfeeding
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Emory University
Atlanta, Georgia, 30322
The University of Texas at Austin
Austin, Texas, 78701
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263
The Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, 43210
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
City of Hope
Duarte, California, 91010
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, 37203
Moffitt Cancer Center
Tampa, Florida, 33612
Canada1 site
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1, Open-Label, Multicenter, 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
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.
Read the detailed description
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.
- Conditions
- Cancer, Melanoma, Solid Tumor, Squamous Cell Carcinoma of Head and Neck, Breast Cancer, Advanced Solid Tumor
- Being tested
- ONCR-177, pembrolizumab
- Medical subject headings
- Neoplasms, Melanoma, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Triple Negative Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONCR-177Biological
Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1
pembrolizumabBiological
Also called MK-3475, KEYTRUDA
Anti-PD-1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation of ONCR-177 by intratumoral injection in subjects with surface lesions | Experimental | Dose escalation of ONCR-177 intratumoral injections alone in four cohorts in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors Receives: Biological: ONCR-177 |
| Dose expansion of ONCR-177 in subjects with surface lesions | Experimental | Dose expansion of ONCR-177 intratumoral injections alone at the recommended phase 2 dose (RP2D) in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors Receives: Biological: ONCR-177 |
| Dose expansion of ONCR-177 and pembrolizumab in subjects with surface lesions | Experimental | Dose expansion of ONCR-177 intratumoral injections at the RP2D in combination with pembrolizumab in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors Receives: Biological: ONCR-177; Biological: pembrolizumab |
| Dose escalation of ONCR-177 by intratumoral injection in subjects with liver metastases | Experimental | Dose escalation of ONCR-177 intratumoral injections alone in four cohorts in subjects with advanced and/or refractory solid tumor cancer with liver metastases Receives: Biological: ONCR-177 |
| Dose expansion of ONCR-177 by intratumoral injection in subjects with liver metastases | Experimental | Dose expansion of ONCR-177 intratumoral injections alone at the recommended phase 2 dose (RP2D) in subjects with advanced and/or refractory solid tumor cancer with liver metastases Receives: Biological: ONCR-177 |
| Dose expansion of ONCR-177 and pembrolizumab in subjects with liver metastases | Experimental | Dose expansion of ONCR-177 intratumoral injections at the RP2D in combination with pembrolizumab in subjects with advanced and/or refractory solid tumor cancer with liver metastases Receives: Biological: ONCR-177; Biological: pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Dose-Limiting Toxicities (DLTs)
Percentage of subjects with DLTs
Measured: From Day 1 up to 30 days after last dose
Percentage of Adverse Events (AEs)
Percentage of subjects with AEs
Measured: From Day 1 up to 30 days after last dose
Percentage of Serious Adverse Events (SAEs)
Percentage of subjects with SAEs
Measured: From Day 1 up to 90 days after last dose
Maximum Tolerated Dose (MTD) of ONCR-177
MTD on the data collected during dose escalation
Measured: 6 Months
Recommended Phase 2 Dose (RP2D) of ONCR-177
RP2D of ONCR-177 based on the data collected during dose escalation
Measured: 6 Months
Secondary outcomes (6)
Percentage of Objective Response Rate (ORR)
Percentage of ORR
Measured: 40 Months
Durable Response Rate (DRR)
DRR (continuous CR or PR ≥6 months)
Measured: 40 Months
Progression Free Survival (PFS)
Duration of PFS for subjects
Measured: 40 Months
Overall Survival (OS)
OS rate for subjects
Measured: 40 Months
Incidence and rate of detection of ONCR-177
Data gathered from blood, urine, swabs of injection site, dressings, and oral mucosa to determine the shedding and biodistribution of ONCR-177
Measured: 6 Months
Changes in the level of HSV-1 antibodies compared to baseline
Change in HSV-1 antibody levels during treatment compared to baseline
Measured: From Day 1 up to last dose of ONCR-177 (up to 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start20 May 2020
- Primary completion31 May 2023
- Study completion31 May 2023
Why it stopped: Terminated due to Oncorus portfolio reprioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncorus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- John Goldberg, MD, Study director, Oncorus, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348916
- Sponsor's protocol ID
- ONCR-177-101
- Other IDs
- KEYNOTE-B73
- Status last verified
- Jun 2023
- First submitted
- 13 Apr 2020
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haines BB, Denslow A, Grzesik P, Lee JS, Farkaly T, Hewett J, Wambua D, Kong L, Behera P, Jacques J, Goshert C, Ball M, Colthart A, Finer MH, Hayes MW, Feau S, Kennedy EM, Lerner L, Queva C. ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity. Cancer Immunol Res. 2021 Mar;9(3):291-308. doi: 10.1158/2326-6066.CIR-20-0609. Epub 2020 Dec 22.
PubMed 33355229
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter, 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
- ClinicalTrials.gov ID
- NCT04348916
- Acronym / sponsor ID
- ONCR-177-101
- Conditions
- Cancer, Melanoma, Solid Tumor, Squamous Cell Carcinoma of Head and Neck, Breast Cancer, Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to Oncorus portfolio reprioritization
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Oncorus, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 20 May 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose escalation of ONCR-177 by intratumoral injection in subjects with surface lesions | Experimental | Biological: ONCR-177Dose escalation of ONCR-177 intratumoral injections alone in four cohorts in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors |
| Dose expansion of ONCR-177 in subjects with surface lesions | Experimental | Biological: ONCR-177Dose expansion of ONCR-177 intratumoral injections alone at the recommended phase 2 dose (RP2D) in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors |
| Dose expansion of ONCR-177 and pembrolizumab in subjects with surface lesions | Experimental | Biological: ONCR-177, Biological: pembrolizumabDose expansion of ONCR-177 intratumoral injections at the RP2D in combination with pembrolizumab in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors |
| Dose escalation of ONCR-177 by intratumoral injection in subjects with liver metastases | Experimental | Biological: ONCR-177Dose escalation of ONCR-177 intratumoral injections alone in four cohorts in subjects with advanced and/or refractory solid tumor cancer with liver metastases |
| Dose expansion of ONCR-177 by intratumoral injection in subjects with liver metastases | Experimental | Biological: ONCR-177Dose expansion of ONCR-177 intratumoral injections alone at the recommended phase 2 dose (RP2D) in subjects with advanced and/or refractory solid tumor cancer with liver metastases |
| Dose expansion of ONCR-177 and pembrolizumab in subjects with liver metastases | Experimental | Biological: ONCR-177, Biological: pembrolizumabDose expansion of ONCR-177 intratumoral injections at the RP2D in combination with pembrolizumab in subjects with advanced and/or refractory solid tumor cancer with liver metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (15 listed)
- Subjects on current antiviral treatment for herpes virus infections
- Requires chronic or intermittent treatment with systemic antivirals
- Any systemic anti-cancer treatment (including investigational agents) within 4 weeks prior to the first dose of study drug
- Has received prior radiotherapy within 2 weeks of start of study treatment
- Myelosuppressive chemotherapy within 4 weeks of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONCR-177Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1 | Biological | Dose escalation of ONCR-177 by intratumoral injection in subjects with liver metastases, Dose escalation of ONCR-177 by intratumoral injection in subjects with surface lesions, Dose expansion of ONCR-177 and pembrolizumab in subjects with liver metastases, Dose expansion of ONCR-177 and pembrolizumab in subjects with surface lesions, Dose expansion of ONCR-177 by intratumoral injection in subjects with liver metastases, Dose expansion of ONCR-177 in subjects with surface lesions |
| pembrolizumabAlso: MK-3475, KEYTRUDAAnti-PD-1 monoclonal antibody | Biological | Dose expansion of ONCR-177 and pembrolizumab in subjects with liver metastases, Dose expansion of ONCR-177 and pembrolizumab in subjects with surface lesions |
Primary outcome
Percentage of Dose-Limiting Toxicities (DLTs)
Time frame: From Day 1 up to 30 days after last dose
Percentage of subjects with DLTs
Percentage of Adverse Events (AEs)
Time frame: From Day 1 up to 30 days after last dose
Percentage of subjects with AEs
Percentage of Serious Adverse Events (SAEs)
Time frame: From Day 1 up to 90 days after last dose
Percentage of subjects with SAEs
Maximum Tolerated Dose (MTD) of ONCR-177
Time frame: 6 Months
MTD on the data collected during dose escalation
Recommended Phase 2 Dose (RP2D) of ONCR-177
Time frame: 6 Months
RP2D of ONCR-177 based on the data collected during dose escalation
6 secondary outcomes
Percentage of Objective Response Rate (ORR)
Time frame: 40 Months
Durable Response Rate (DRR)
Time frame: 40 Months
Progression Free Survival (PFS)
Time frame: 40 Months
Overall Survival (OS)
Time frame: 40 Months
Incidence and rate of detection of ONCR-177
Time frame: 6 Months
Changes in the level of HSV-1 antibodies compared to baseline
Time frame: From Day 1 up to last dose of ONCR-177 (up to 5 months)
Results and safety
The study was stopped early (reason given: Terminated due to Oncorus portfolio reprioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Derived from this study: PubMed 33355229Haines BB, Denslow A, Grzesik P, Lee JS, Farkaly T, Hewett J, Wambua D, Kong L, Behera P, Jacques J, Goshert C, Ball M, Colthart A, Finer MH, Hayes MW, Feau S, Kennedy EM, Lerner L, Queva C. ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity. Cancer Immunol Res. 2021 Mar;9(3):291-308. doi: 10.1158/2326-6066.CIR-20-0609. Epub 2020 Dec 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Goldberg, MD study director
Oncorus, Inc.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONCR-177 and pembrolizumab in people with Cancer and Melanoma, run by Oncorus, Inc. at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated due to Oncorus portfolio reprioritization). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Dose-Limiting Toxicities (DLTs) (time frame: From Day 1 up to 30 days after last dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04348916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.