Clinical Trials in the USA / NCT07525141
Recruiting
Phase 1
A Study of JNJ-1761981 in Participants With Solid Tumors
NCT07525141 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Neoplasms
Investigational drug(s) / intervention(s)
JNJ-1761981Cetrelimab →
JNJ-1761981: JNJ-1761981 will be administered intratumorally.
Cetrelimab: Cetrelimab will be administered intravenously.
Study 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.
Eligibility
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
Primary outcome measure(s)
- Part 1: Number of Participants with Adverse Events (AE) by Severity — 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. - Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs) — 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. - Part 1: Number of Participants with AEs by Severity Related to Delivery Device and/or Procedure — 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. - Part 1: Number of Participants who Received Planned Total Dose per Level — Up to approximately 28 days
Number of participants who received planned total dose per level will be reported. - Part 2: Administered Tumor Response Rate — 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).
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | Recruiting |
| Montefiore Medical Center | The Bronx | New York | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07525141 on ClinicalTrials.gov ↗ ← All trials in the USA