A Study of JNJ-1761981 in Participants With Solid Tumors

This study is testing two drugs, JNJ-1761981 and Cetrelimab, in people with solid tumors (cancers that form solid masses). JNJ-1761981 will be given directly into the tumor, and Cetrelimab will be given through a vein. The main goals of the study are to find a safe and tolerable dose of JNJ-1761981 and to figure out the best amount of JNJ-1761981 to treat tumors. You may be able to join if you have locally advanced or metastatic (spread to other parts of the body) solid tumors, have already tried standard treatments, or cannot tolerate them. The study is currently unclear on its recruitment status and plans to enroll 66 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 66 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events (side effects) for up to approximately 2 years and 10 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07525141

A Study of JNJ-1761981 in Participants With Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Johnson & Johnson Enterprise Innovation Inc.
~66 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:JNJ-1761981Cetrelimab

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of Participants with Adverse Events (AE) by Severity
Measured over Up to approximately 2 years 10 months
+4 more outcomes measured
Neoplasms
4 sites across 4 states
Florida1
Minnesota1
New York1
Texas1
  • Johnson & Johnson Enterprise Innovation, Inc Clinical Trial · STUDY_DIRECTOR · Johnson & Johnson Enterprise Innovation Inc.

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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
  • Part 1: Number of Participants with Adverse Events (AE) by SeverityUp to approximately 2 years 10 months

    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.

  • Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)Up to 28 days

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

  • Part 1: Number of Participants with AEs by Severity Related to Delivery Device and/or ProcedureUp to approximately 2 years 10 months

    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.

  • Part 1: Number of Participants who Received Planned Total Dose per LevelUp to approximately 28 days

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

  • Part 2: Administered Tumor Response RateUp to approximately 2 years 10 months

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