A Study of JNJ-1761981 in Participants With Solid Tumors

Purpose

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.

Condition

  • Neoplasms

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: Dose Escalation 		Participants will receive JNJ-1761981 intratumorally to determine a safe and tolerable total JNJ-1761981 dose.
  • Drug: JNJ-1761981
    JNJ-1761981 will be administered intratumorally.
Experimental
Part 2: Dose Expansion 		Participants in Cohort A will receive JNJ-1761981 at specified volumetric doses. Participants who receive more than 1 dose of JNJ-1761981 may receive optional systemic therapy with cetrelimab at the discretion of the treating physician.
  • Drug: JNJ-1761981
    JNJ-1761981 will be administered intratumorally.
  • Drug: Cetrelimab
    Cetrelimab will be administered intravenously.
    Other names:
    • JNJ-63723283

Recruiting Locations

Montefiore Medical Center
The Bronx, New York 10467

MD Anderson Cancer Center
Houston, Texas 77030

More Details

Status
Recruiting
Sponsor
Johnson & Johnson Enterprise Innovation Inc.

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com