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A Study of JNJ-1761981 in Participants With Solid Tumors
Trial Status: active
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07525141.
Locations matching your search criteria
United States
Florida
Jacksonville
Mayo Clinic in Florida
Status: Approved
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Approved
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationJohnson & Johnson Enterprise Innovation Inc.