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NCT07525141From ClinicalTrials.govRecruiting

A Study of JNJ-1761981 in Participants With Solid Tumors

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

  • Neoplasms

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Johnson & Johnson Enterprise Innovation Inc.
Enrolment target
66
Started
18 May 2026
Main results due
12 January 2028
Study sites
4
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(4)

  • 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

Showing 4 of 4 sites. 4 of the 4 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07525141. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study of JNJ-1761981 in Participants With Solid Tumors | Trialion