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Trial Title:
A Study of JNJ-87704916, as Monotherapy and in Combination for Advanced Solid Tumors
NCT ID:
NCT06311578
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JNJ-87704916
Description:
JNJ-87704916 will be administered as an intratumoral injection.
Arm group label:
Part 1: Dose Escalation
Arm group label:
Part 2: Dose Expansion
Intervention type:
Drug
Intervention name:
Cetrelimab
Description:
Cetrelimab will be administered.
Arm group label:
Part 1: Dose Escalation
Arm group label:
Part 2: Dose Expansion
Other name:
JNJ-63723283
Summary:
The purpose of this study is to determine the safety, feasibility, recommended dose(s)
and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor
exhausting all available standard of care therapy; Part 2: Individuals with
histologically or cytologically confirmed metastatic or locally advanced NSCLC
- Have at least 1 injectable tumor
- Eastern cooperative oncology group (ECOG) performance status of grade 0 or 1
- A participant who can have children must have a negative pregnancy test before the
first dose of study treatment and during the study
Exclusion Criteria:
- Active disease involvement of the CNS (example, primary central nervous system
tumors, metastases, leptomeningeal disease). Some exceptions are allowed
- Prior history of, or active, significant herpetic infections (example, herpetic
keratitis or encephalitis) or active herpetic infections that require ongoing
systemic anti-viral therapy
- Active infection or condition that requires treatment with systemic anti-infective
agents (example, antibiotics, antifungals, or antivirals) within 7 days prior to the
first dose of study treatment or chronic use of anti-infective agents
- History of solid organ or hematologic stem cell transplantation
- Known positive test result for human immunodeficiency virus (HIV) or other
immunodeficiency syndrome
- History of Grade 3 or higher toxic effects during prior treatment with immunotherapy
or requirement of anti-tumor necrosis factor (TNF) or anti-interleukin 6 (IL-6)
agents to manage AEs from prior treatment with immunotherapy
- History of allergy to protein-based therapies or history of any significant drug
allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or
anemia)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Facility:
Name:
UPMC Cancer Centers
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Hosp Univ Fund Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Univ Hm Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Start date:
April 10, 2024
Completion date:
November 30, 2033
Lead sponsor:
Agency:
Johnson & Johnson Enterprise Innovation Inc.
Agency class:
Industry
Source:
Johnson & Johnson Enterprise Innovation Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06311578
