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NCT Number: NCT07525141

A Study of JNJ-1761981 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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Florida, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-1761981

Drug

JNJ-1761981 will be administered intratumorally.

Cetrelimab

Drug

Cetrelimab will be administered intravenously.

Other names: JNJ-63723283

Primary outcomes

  1. Part 1: Number of Participants with Adverse Events (AE) by Severity

    Time frame: Up to approximately 2 years 10 months

    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.

  2. Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)

    Time frame: Up to 28 days

    High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.

  3. 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

    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.

  4. Part 1: Number of Participants who Received Planned Total Dose per Level

    Time frame: Up to approximately 28 days

    Number of participants who received planned total dose per level will be reported.

  5. Part 2: Administered Tumor Response Rate

    Time frame: Up to approximately 2 years 10 months

    Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve complete response (CR) or partial response (PR).

Secondary outcomes

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

    Time frame: Up to approximately 2 years 10 months

    Plasma concentration of free and total platinum will be assessed.

  2. Part 1: Administered Tumor Response Rate

    Time frame: Up to approximately 2 years 10 months

    Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve CR or PR.

  3. Parts 1 and 2: Administered Tumor Duration of Response

    Time frame: Up to approximately 2 years 10 months

    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.

  4. Parts 1 and 2: Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years 10 months

    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.

  5. Parts 1 and 2: Disease Control Rate (DCR)

    Time frame: Up to approximately 2 years 10 months

    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.

  6. Parts 1 and 2: Duration of Response (DOR)

    Time frame: Up to approximately 2 years 10 months

    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.

  7. Part 2: Number of Participants with Adverse Events (AE) by Severity

    Time frame: Up to approximately 2 years 10 months

    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.

  8. Part 2: Number of Participants with AE by Severity Related to Delivery Device and/or Procedure

    Time frame: Up to approximately 2 years 10 months

    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.

  9. Part 2: Number of Participants who Received Planned Intratumoral Volumetric Dose

    Time frame: Up to approximately 2 years 10 months

    Number of participants who received the planned intratumoral volumetric dose will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Enterprise Innovation Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 13, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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