A Study of JNJ-1761981 in Participants With Solid Tumors

ConditionNeoplasms
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohnson & Johnson Enterprise Innovation Inc.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • JNJ-1761981
  • Cetrelimab

Treatment groups

66 Participants
are divided into 2 treatment groups