NeoplasmsPhase 1NCT06311578
A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors
A Phase 1 study testing JNJ-87704916 and Cetrelimab in people with Neoplasms, run by Johnson & Johnson Enterprise Innovation Inc. at 10 sites in 4 countries.
Trial summary
The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- JNJ-87704916 and Cetrelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 10 Apr 2024to 14 Feb 2033
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor exhausting all available standard of care therapy; Part 2: Individuals with histologically or cytologically confirmed metastatic or locally advanced NSCLC
- Have at least 1 injectable tumor
- Eastern cooperative oncology group (ECOG) performance status of grade 0 or 1
- A participant who can have children must have a negative pregnancy test before the first dose of study treatment and during the study
- Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
Who cannot join
- Active disease involvement of the CNS (example, primary central nervous system tumors, metastases, leptomeningeal disease). Some exceptions are allowed
- Prior history of, or active, significant herpetic infections (example, herpetic keratitis or encephalitis) or active herpetic infections that require ongoing systemic anti-viral therapy
- Active infection or condition that requires treatment with systemic anti-infective agents (example, antibiotics, antifungals, or antivirals) within 7 days prior to the first dose of study treatment or chronic use of anti-infective agents
- History of solid organ or hematologic stem cell transplantation
- Known positive test result for human immunodeficiency virus (HIV) or other immunodeficiency syndrome
- History of allergy to protein-based therapies or history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia)
Trial locations and contacts
10 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 4 countries
United States4 sites, 3 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
NYU Langone Health
New York, New York, 10016
- Suspended
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
- Recruiting
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232
Spain3 sites, 3 recruiting
- Recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035
- Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
- Recruiting
Hosp Univ Hm Sanchinarro
Madrid, 28050
Canada2 sites, 2 recruiting
- Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.
- Conditions
- Neoplasms
- Being tested
- JNJ-87704916, Cetrelimab, Standard of Care PD(L)-1
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-87704916Drug
JNJ-87704916 will be administered as an intratumoral injection.
CetrelimabDrug
Also called JNJ-63723283
Cetrelimab will be administered.
Standard of Care PD(L)-1Drug
Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested. Receives: Drug: JNJ-87704916; Drug: Cetrelimab |
| Part 2: Dose Expansion | Experimental | Part 2 will consist of three cohorts: Cohort A, B and C. Participants in cohort A\&B with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Cohort C will evaluate JNJ-87704916 treatment in combination with ongoing Standard of care (SoC) PD(L)-1 antibody therapy in frontline treatment of NSCLC. Receives: Drug: JNJ-87704916; Drug: Cetrelimab; Drug: Standard of Care PD(L)-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol.
Measured: Up to 5 years
Number of Participants with Adverse Events (AEs) by Severity
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.
Measured: From first dose up to 100 days after last dose of study treatment (up to 5 years)
Secondary outcomes (8)
Parts 1 and 2: Percentage of Participants With Objective Response (OR)
OR is defined as the percentage of participants who have best response of Complete Response (CR) or Partial Response (PR) according to response evaluation criteria in solid tumors (RECIST) v1.1.
Measured: Up to 5 years
Parts 1 and 2: Percentage of Participants With Disease Control (DC)
DC is defined as the percentage of participants who have achieved complete response, partial response, and stable disease for at least 2 consecutive assessments according to RECIST v1.1.
Measured: Up to 5 years
Parts 1 and 2: Duration of Response (DOR)
DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse according to RECIST v1.1, or death due to any cause, whichever occurs first.
Measured: Up to 5 years
Part 2: Progression Free Survival (PFS)
PFS is defined as the time from treatment initiation until disease progression or worsening or death due to any cause.
Measured: From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years)
Part 2: Overall Survival (OS)
OS is defined as the time from treatment initiation until death due to any cause.
Measured: From treatment initiation until death due to any cause (up to 5 years)
Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter
Viral genome copies of JNJ-87704916 collected from samples (that is, blood, urine, oral mucosa, injection sites, and dressings) will be determined by quantitative polymerase chain reaction (qPCR) assays.
Measured: Up to 5 years
Parts 1 and 2: Payload Concentrations of JNJ-87704916
Blood samples will be collected to characterize JNJ-87704916 payload concentrations in blood will be analyzed using immunoassay.
Measured: Up to 2 years
Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies
Antibodies against JNJ-87704916 encoded payloads and against herpes simplex virus type-1 (HSV-1) will be analyzed.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start10 Apr 2024
- Primary completion8 Nov 2028 (estimated)
- Study completion14 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Enterprise Innovation Inc Clinical Trial, Study director, Johnson & Johnson Enterprise Innovation Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311578
- Sponsor's protocol ID
- 87704916LUC1001
- Other IDs
- 2023-506495-27-00, 2023
- Status last verified
- Nov 2026
- First submitted
- 8 Mar 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06311578
- Acronym / sponsor ID
- 87704916LUC1001
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Johnson & Johnson Enterprise Innovation Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 8 Nov 2028 (estimated)
- Study completion
- 14 Feb 2033 (estimated)
- First posted
- 15 Mar 2024 (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.
The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: JNJ-87704916, Drug: CetrelimabParticipants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested. |
| Part 2: Dose Expansion | Experimental | Drug: JNJ-87704916, Drug: Cetrelimab, Drug: Standard of Care PD(L)-1Part 2 will consist of three cohorts: Cohort A, B and C. Participants in cohort A\&B with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Cohort C will evaluate JNJ-87704916 treatment in combination with ongoing Standard of care (SoC) PD(L)-1 antibody therapy in frontline treatment of NSCLC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor exhausting all available standard of care therapy; Part 2: Individuals with histologically or cytologically confirmed metastatic or locally advanced NSCLC
- Have at least 1 injectable tumor
- Eastern cooperative oncology group (ECOG) performance status of grade 0 or 1
- A participant who can have children must have a negative pregnancy test before the first dose of study treatment and during the study
- Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
Key exclusion criteria (6 listed)
- Active disease involvement of the CNS (example, primary central nervous system tumors, metastases, leptomeningeal disease). Some exceptions are allowed
- Prior history of, or active, significant herpetic infections (example, herpetic keratitis or encephalitis) or active herpetic infections that require ongoing systemic anti-viral therapy
- Active infection or condition that requires treatment with systemic anti-infective agents (example, antibiotics, antifungals, or antivirals) within 7 days prior to the first dose of study treatment or chronic use of anti-infective agents
- History of solid organ or hematologic stem cell transplantation
- Known positive test result for human immunodeficiency virus (HIV) or other immunodeficiency syndrome
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 |
|---|---|---|
| JNJ-87704916JNJ-87704916 will be administered as an intratumoral injection. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| CetrelimabAlso: JNJ-63723283Cetrelimab will be administered. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| Standard of Care PD(L)-1Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment. | Drug | Part 2: Dose Expansion |
Primary outcome
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Time frame: Up to 5 years
The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol.
Number of Participants with Adverse Events (AEs) by Severity
Time frame: From first dose up to 100 days after last dose of study treatment (up to 5 years)
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.
8 secondary outcomes
Parts 1 and 2: Percentage of Participants With Objective Response (OR)
Time frame: Up to 5 years
Parts 1 and 2: Percentage of Participants With Disease Control (DC)
Time frame: Up to 5 years
Parts 1 and 2: Duration of Response (DOR)
Time frame: Up to 5 years
Part 2: Progression Free Survival (PFS)
Time frame: From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years)
Part 2: Overall Survival (OS)
Time frame: From treatment initiation until death due to any cause (up to 5 years)
Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter
Time frame: Up to 5 years
Parts 1 and 2: Payload Concentrations of JNJ-87704916
Time frame: Up to 2 years
Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Johnson & Johnson Enterprise Innovation Inc Clinical Trial study director
Johnson & Johnson Enterprise Innovation Inc.
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-87704916 and Cetrelimab in people with Neoplasms, run by Johnson & Johnson Enterprise Innovation Inc. at 10 sites in 4 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Spain, Canada, France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.