The purpose of this study is to determine recommended phase 2 doses (RP2Ds) of JNJ-95437446 in Part 1, and to further evaluate the safety of the RP2Ds in participants with advanced solid tumors in Part 2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
380
JNJ-95437446 will be administered.
Florida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGTennessee Oncology
Nashville, Tennessee, United States
RECRUITINGNEXT Oncology
Fairfax, Virginia, United States
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 and 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 and 4 months
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation.
Time frame: Up to 21 days
Objective Response Rate
Objective response rate (ORR) is defined as the percentage of participants who have best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST).
Time frame: Up to 2 years and 4 months
Duration of Response (DOR)
DOR is defined for the responders from the date of initial documentation of a response to the date of first documented evidence of disease progression according to RECIST version (v.) 1.1, or death due to any cause, whichever occurs first.
Time frame: Up to 2 years and 4 months
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of JNJ-95437446 to either progressive disease (PD) or death due to any cause, whichever comes first.
Time frame: Up to 2 years and 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Severance Hospital Yonsei University Health System
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGHosp Univ Vall D Hebron
Barcelona, Spain
RECRUITINGHosp Univ Fund Jimenez Diaz
Madrid, Spain
RECRUITINGHosp. Univ. 12 de Octubre
Madrid, Spain
RECRUITINGHosp Univ Hm Sanchinarro
Madrid, Spain
RECRUITINGMaximum Plasma Concentration (Cmax) for JNJ-95437446
Serum samples will be analyzed to determine Cmax of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite.
Time frame: Up to 2 years and 4 months
Time to Reach Cmax (Tmax) for JNJ-95437446
Tmax defined as the the time to reach maximum observed plasma concentration of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported.
Time frame: Up to 2 years and 4 months
Area Under the Plasma Concentration - Time (AUC [0-t]) Curve for JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite.
AUC (0-t) defined as area under the plasma concentration-time curve during a dosing interval of JNJ-95437446 antibody-drug conjugate, total antibody, released payload and the payload's metabolite will be reported.
Time frame: Up to 2 years and 4 months
Number of Participants With Anti JNJ-95437446 Antibodies
Serum samples will be analyzed for the detection of anti-JNJ-95437446 antibodies using a validated assay method.
Time frame: Up to 2 years and 4 months