JNJ-95437446
DrugJNJ-95437446 will be administered.
NCT Number: NCT07107230
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Samsung Medical Center, Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-95437446 will be administered.
Time frame: Up to 2 years and 4 months
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 21 days
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 2 years and 4 months
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
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
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
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
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
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
Serum samples will be analyzed for the detection of anti-JNJ-95437446 antibodies using a validated assay method.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
A Phase 1 Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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