Recruiting
Phase 1

JNJ-1761981

Sponsor:

Johnson & Johnson Enterprise Innovation Inc.

Code:

NCT07525141

Conditions

Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-1761981

Cetrelimab

Study Details

Brief 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.

Conditions

Neoplasms

Study ID

NCT07525141

Start date

May 18, 2026

Status verified date

Aug, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

66 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Dose Escalation

Participants will receive JNJ-1761981 intratumorally to determine a safe and tolerable total JNJ-1761981 dose.

experimental: Part 2: Dose Expansion

Participants 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.

Interventions

JNJ-1761981

JNJ-1761981 will be administered intratumorally.

Cetrelimab

Cetrelimab will be administered intravenously.

Primary outcome measure

  • Part 1: Number of Participants with Adverse Events (AE) by Severity [ Time Frame: Up to approximately 2 years 10 months ]
  • Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
  • Part 1: Number of Participants with AEs by Severity Related to Delivery Device and/or Procedure [ Time Frame: Up to approximately 2 years 10 months ]
  • Part 1: Number of Participants who Received Planned Total Dose per Level [ Time Frame: Up to approximately 28 days ]
  • Part 2: Administered Tumor Response Rate [ Time Frame: Up to approximately 2 years 10 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johnson & Johnson Enterprise Innovation Inc. on 2026-08-28.