A Study of JNJ-1761981 in Participants With Solid Tumors

NCT07525141 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 1761981STM1001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (5)

• 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.

  Up to approximately 2 years 10 months

• 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.

  Up to 28 days

• 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.

  Up to approximately 2 years 10 months

• 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.

  Up to approximately 28 days

• 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).

  Up to approximately 2 years 10 months

Secondary Outcomes (9)

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

  Up to approximately 2 years 10 months

• Part 1: Administered Tumor Response Rate

  Up to approximately 2 years 10 months

• Parts 1 and 2: Administered Tumor Duration of Response

  Up to approximately 2 years 10 months

• Parts 1 and 2: Objective Response Rate (ORR)

  Up to approximately 2 years 10 months

• Parts 1 and 2: Disease Control Rate (DCR)

  Up to approximately 2 years 10 months

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

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

Drug: JNJ-1761981

Part 2: Dose Expansion

EXPERIMENTAL

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.

Drug: JNJ-1761981; Drug: Cetrelimab

Interventions

JNJ-1761981 DRUG

JNJ-1761981 will be administered intratumorally.

Part 1: Dose Escalation; Part 2: Dose Expansion

Cetrelimab DRUG

Cetrelimab will be administered intravenously.

Also known as: JNJ-63723283

Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Enterprise Innovation Inc.: lead

Study Sites (2)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Johnson & Johnson Enterprise Innovation, Inc Clinical Trial

  Johnson & Johnson Enterprise Innovation Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): January 12, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (2)