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NeoplasmsPhase 1NCT07525141

A Study of JNJ-1761981 in Participants With Solid Tumors

A Phase 1 study testing JNJ-1761981 and Cetrelimab in people with Neoplasms, run by Johnson & Johnson Enterprise Innovation Inc. at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of Part 1 of this study is to determine a safe, tolerable, and feasible recommended total dose of intratumorally administered JNJ-1761981. The purpose of Part 2 of this study is to identify the optimal volumetric dose of JNJ-1761981 for the treatment of tumor lesions. 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-1761981 and Cetrelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
4 sitesUnited States
Study dates
18 May 2026to 31 Jan 2029
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

  • Part 1: Individuals with a diagnosis of locally advanced or metastatic disease (solid tumors except tumors of the central nervous system [CNS]) who have previously received available standard therapy and progressed, or cannot tolerate standard therapy, or for whom there is no standard of care per regional guidelines
  • Part 2 Cohort A: Individuals with histologically or cytologically confirmed metastatic tumors of adenocarcinoma or squamous cell carcinoma histology, for which any platinum-based systemic regimen is considered a standard of care (per national comprehensive cancer network [NCCN] guidelines) and whose disease has progressed after standard therapy
  • Eastern cooperative oncology group performance status (ECOG) performance status of Grade 0 or 1
  • Part 2 Cohort A participants planned to receive optional cetrelimab (participants not meeting this criterion may still be enrolled in the study but cannot receive cetrelimab): Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
  • A participant of childbearing potential must practice at least 2 highly effective methods of contraception throughout the study and through 14 months (for women) and 11 months (for men) after the last dose of JNJ-1761981 or 5 months after the last dose of cetrelimab or other anti-PD(L)1 treatment, whichever is later

Who cannot join

  • Active symptomatic disease involvement of the central nervous system
  • Prior or concurrent second malignancy (other than the disease under study) that due to natural history or treatment is likely to interfere with any study endpoints of safety or the antitumor activity of the study treatment(s)
  • Active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures
  • Known allergies, hypersensitivity, or intolerance to JNJ-1761981 or its excipients
  • Lesions invading or adjacent to major blood vessels or other critical structures (for example, airways) not suitable for injection

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

United States4 sites, 4 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Recruiting

Other trials in United States

About this study

Official title: Phase 1 Study of Intratumoral Administration of JNJ-1761981 ER, an Extended Release Chemotherapy, in Participants With Solid Tumors

The purpose of Part 1 of this study is to determine a safe, tolerable, and feasible recommended total dose of intratumorally administered JNJ-1761981. The purpose of Part 2 of this study is to identify the optimal volumetric dose of JNJ-1761981 for the treatment of tumor lesions.

Conditions
Neoplasms
Being tested
JNJ-1761981, Cetrelimab
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-1761981Drug

    JNJ-1761981 will be administered intratumorally.

  • CetrelimabDrug

    Also called JNJ-63723283

    Cetrelimab will be administered intravenously.

Study groups in NCT07525141
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalParticipants will receive JNJ-1761981 intratumorally to determine a safe and tolerable total JNJ-1761981 dose.
Receives: Drug: JNJ-1761981
Part 2: Dose ExpansionExperimentalParticipants in Cohort A will receive JNJ-1761981 at specified volumetric doses. Participants who receive more than 1 dose of JNJ-1761981 may receive optional systemic therapy with cetrelimab at the discretion of the treating physician.
Receives: Drug: JNJ-1761981; Drug: Cetrelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants with Adverse Events (AE) by Severity

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.

    Measured: Up to approximately 2 years 10 months

  2. Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)

    High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.

    Measured: Up to 28 days

  3. Part 1: Number of Participants with AEs by Severity Related to Delivery Device and/or Procedure

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Participants with AEs related to delivery device and/or procedure will be reported.

    Measured: Up to approximately 2 years 10 months

  4. Part 1: Number of Participants who Received Planned Total Dose per Level

    Number of participants who received planned total dose per level will be reported.

    Measured: Up to approximately 28 days

  5. Part 2: Administered Tumor Response Rate

    Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve complete response (CR) or partial response (PR).

    Measured: Up to approximately 2 years 10 months

Secondary outcomes (9)

  1. Parts 1 and 2: Plasma Concentration of Free and Total Platinum

    Plasma concentration of free and total platinum will be assessed.

    Measured: Up to approximately 2 years 10 months

  2. Part 1: Administered Tumor Response Rate

    Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve CR or PR.

    Measured: Up to approximately 2 years 10 months

  3. Parts 1 and 2: Administered Tumor Duration of Response

    Administered tumor duration of response will be calculated among JNJ-1761981 administered lesions that responded from the date of initial documentation of lesion response to the date of first documented evidence of progression or start of subsequent anticancer treatment or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years 10 months

  4. Parts 1 and 2: Objective Response Rate (ORR)

    ORR 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) version 1.1.

    Measured: Up to approximately 2 years 10 months

  5. Parts 1 and 2: Disease Control Rate (DCR)

    DCR is defined as the percentage of participants who have achieved CR, PR, and stable disease for at least 4 weeks after study treatment was administered.

    Measured: Up to approximately 2 years 10 months

  6. Parts 1 and 2: Duration of Response (DOR)

    DOR will be calculated among responders from the date of initial documentation of a response (first CR/PR) to the date of first documented evidence of progression according to RECIST v.1.1, or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years 10 months

  7. Part 2: Number of Participants with Adverse Events (AE) by Severity

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the NCI-CTCAE v 5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.

    Measured: Up to approximately 2 years 10 months

  8. Part 2: Number of Participants with AE by Severity Related to Delivery Device and/or Procedure

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Participants with AEs related to delivery device and/or procedure will be reported.

    Measured: Up to approximately 2 years 10 months

  9. Part 2: Number of Participants who Received Planned Intratumoral Volumetric Dose

    Number of participants who received the planned intratumoral volumetric dose will be reported.

    Measured: Up to approximately 2 years 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start18 May 2026
  3. Primary completion12 Jan 2028 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

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
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07525141
Sponsor's protocol ID
1761981STM1001
Other IDs
1761981STM1001
Status last verified
Nov 2026
First submitted
6 Apr 2026
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-1761981 and Cetrelimab in people with Neoplasms, run by Johnson & Johnson Enterprise Innovation Inc. at 4 sites in United States.

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 5 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 4 sites in United States. 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 Adverse Events (AE) by Severity (time frame: Up to approximately 2 years 10 months). 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 NCT07525141.

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.

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