Home › Trials › NCT07525141
Clinical trial Recruiting at 4 sites Phase 1 Interventional Ages 18 and up

JNJ-1761981 in solid tumors

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

Run by Johnson & Johnson Enterprise Innovation Inc. · NCT07525141 · Data updated 2026-11-12

A early-phase study tests how safe and tolerable a single intratumor injection of JNJ-1761981 is, and how to best dose it, in adults with solid tumors that have progressed after standard treatment.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment66 (estimated)
SponsorJohnson & Johnson Enterprise Innovation Inc.
Industry-sponsored
Drugs / interventionscetrelimab
Locations4 sites (Jacksonville, Florida and 3 other locations)
StatusRecruiting
StartedMay 18, 2026
Main results expectedJanuary 12, 2028
Study endsJanuary 31, 2029
Registry record updatedNovember 3, 2026
Trial IDNCT07525141 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with locally advanced or metastatic solid tumors (excluding CNS) who have progressed after standard therapy or cannot tolerate it, and who fit the specific Part 2 eligibility for histology and ECOG 0-1.

Probably not a fit

Patients whose tumors do not respond to intratumoral JNJ-1761981 or who do not receive cetrelimab due to eligibility limits may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study explores intratumoral JNJ-1761981, alone and with optional cetrelimab, to determine a safe total dose and the optimal tumor-volume dose for treating solid tumors. Part 1 focuses on safety, tolerability, and feasibility of the recommended total dose. Part 2 seeks to identify the best intratumoral dosing strategy for tumor lesions in patients whose disease has progressed after standard therapies. Eligible participants include adults with locally advanced or metastatic solid tumors (excluding CNS cancers) and those whose disease progressed on or could not tolerate standard therapy. Study sites include Mayo Clinic in Florida and Rochester, and Montefiore Medical Center in the Bronx, under Johnson & Johnson Enterprise Innovation Inc.

Why it matters

Potential benefit: Participants may experience disease stabilization or tumor responses if the treatment proves effective, contributing to the development of new intratumoral therapies.

How similar studies have gone: Early-phase studies in intratumoral therapies have shown safety signals and dose-finding feasibility, but this exact approach with JNJ-1761981 is novel/limited in prior data.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion criteria:

* 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 criteria:

* 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

Where it's running

  • Mayo Clinic in Florida
    Jacksonville, Florida, United States     Recruiting
  • Mayo Clinic Rochester
    Rochester, Minnesota, United States     Recruiting
  • Montefiore Medical Center
    The Bronx, New York, United States     Recruiting
  • MD Anderson Cancer Center
    Houston, Texas, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Neoplasms 154Johnson & Johnson Enterprise Innovation Inc. 5
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.