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Recruiting NCT07525141

A Study of JNJ-1761981 in Participants With Solid Tumors

Phase I Interventional Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JNJ-1761981, Cetrelimab.
Who it may be relevant to
Registry conditions: Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug JNJ-1761981
    JNJ-1761981 will be administered intratumorally.
  • Drug Cetrelimab
    Cetrelimab will be administered intravenously.

Primary outcome measures

  • 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]
Secondary outcome measures (9)
  • Parts 1 and 2: Plasma Concentration of Free and Total Platinum [Time frame: Up to approximately 2 years 10 months]
  • Part 1: Administered Tumor Response Rate [Time frame: Up to approximately 2 years 10 months]
  • Parts 1 and 2: Administered Tumor Duration of Response [Time frame: Up to approximately 2 years 10 months]
  • Parts 1 and 2: Objective Response Rate (ORR) [Time frame: Up to approximately 2 years 10 months]
  • Parts 1 and 2: Disease Control Rate (DCR) [Time frame: Up to approximately 2 years 10 months]
  • Parts 1 and 2: Duration of Response (DOR) [Time frame: Up to approximately 2 years 10 months]
  • Part 2: Number of Participants with Adverse Events (AE) by Severity [Time frame: Up to approximately 2 years 10 months]
  • 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]
  • Part 2: Number of Participants who Received Planned Intratumoral Volumetric Dose [Time frame: Up to approximately 2 years 10 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Mayo Clinic in Florida — Jacksonville
  • Mayo Clinic Rochester — Rochester
  • Montefiore Medical Center — The Bronx
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT07525141 · 1761981STM1001 · 1761981STM1001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗