A Phase 1 Study of JNJ-86974680, an A2a Receptor Antagonist, Administered as Monotherapy and in Combination With Cetrelimab and Radiotherapy for Advanced Non-small Cell Lung Cancer
Summary
The purpose of this study is to determine a safe and tolerable dose(s) of JNJ-86974680 for further research in combination with cetrelimab and radiation therapy.
Arms & interventions
- DrugJNJ-86974680
JNJ-86974680 will be administered.
- DrugCetrelimab
Cetrelimab will be administered.
- RadiationRadiation Therapy
Radiation therapy will be administered.
Outcome measures
Primary
Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to 2 years 5 months
Number of Participants with Dose Limiting Toxicities (DLTs)
The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.
Time frame: Up to 2 years 5 months
Secondary
Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680
Time frame: Up to 2 years 5 months
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680
Time frame: Up to 2 years 5 months
Part 2: Overall Response Rate (ORR)
Time frame: Up to 2 years 5 months
Part 2: Complete Response Rate (CRR)
Time frame: Up to 2 years 5 months
Part 2: Duration of Response (DOR)
Time frame: Up to 2 years 5 months
Part 2: Disease Control Rate (DCR)
Time frame: Up to 2 years 5 months
Eligibility criteria
Study locations (7)
City of Hope 1
Newnan, Georgia, 30265
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032
Providence Portland Medical Center
Portland, Oregon, 97213
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Next Virginia
Fairfax, Virginia, 22031