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

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 Overview

• Status: Recruiting
• Conditions: Neoplasms
• Intervention / Treatment: Drug: JNJ-1761981; Drug: Cetrelimab

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dose Escalation; Participants will receive JNJ-1761981 intratumorally to determine a safe and tolerable total JNJ-1761981 dose.	Drug: JNJ-1761981; JNJ-1761981 will be administered intratumorally.
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.	Drug: JNJ-1761981; JNJ-1761981 will be administered intratumorally.; Drug: Cetrelimab; Cetrelimab will be administered intravenously.; Other Names: JNJ-63723283

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts 1 and 2: Plasma Concentration of Free and Total Platinum	Plasma concentration of free and total platinum will be assessed.	Up to approximately 2 years 10 months
Part 1: Administered Tumor Response Rate	Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve CR or PR.	Up to approximately 2 years 10 months
Parts 1 and 2: Administered Tumor Duration of Response	Administered tumor duration of response will be calculated among JNJ-1761981 administered lesions that responded from the date of initial documentation of lesion response to the date of first documented evidence of progression or start of subsequent anticancer treatment or death due to any cause, whichever occurs first.	Up to approximately 2 years 10 months
Parts 1 and 2: Objective Response Rate (ORR)	ORR is defined as the percentage of participants who have best response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to approximately 2 years 10 months
Parts 1 and 2: Disease Control Rate (DCR)	DCR is defined as the percentage of participants who have achieved CR, PR, and stable disease for at least 4 weeks after study treatment was administered.	Up to approximately 2 years 10 months
Parts 1 and 2: Duration of Response (DOR)	DOR will be calculated among responders from the date of initial documentation of a response (first CR/PR) to the date of first documented evidence of progression according to RECIST v.1.1, or death due to any cause, whichever occurs first.	Up to approximately 2 years 10 months
Part 2: 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 NCI-CTCAE 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 2: Number of Participants with AE 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 2: Number of Participants who Received Planned Intratumoral Volumetric Dose	Number of participants who received the planned intratumoral volumetric dose will be reported.	Up to approximately 2 years 10 months

Collaborators and Investigators

• Sponsor: Johnson & Johnson Enterprise Innovation Inc.
• Investigators: Study Director: Johnson & Johnson Enterprise Innovation, Inc Clinical Trial, Johnson & Johnson Enterprise Innovation Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): January 12, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 1761981STM1001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No