The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D\[s\]), optimal dosing schedule(s) and route(s) of administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
167
JNJ-80948543 will be administered as SC or IV injection.
City of Hope
Duarte, California, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Number of Participants with Dose-limiting Toxicity (DLT)
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Time frame: Up to 4 Years 3 months
Number of Participants with Adverse Events (AEs)
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.
Time frame: Up to 4 Years 3 months
Number of Participants with AE by Severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded as per American Society for Transplantation and Cellular Therapy (ASTCT).
Time frame: Up to 4 Years 3 months
Serum Concentration of JNJ-80948543
Serum samples will be analyzed to determine concentrations of JNJ-80948543 using a validated, specific, and sensitive method.
Time frame: Up to 4 Years 3 months
Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543
Number of participants with presence of anti-drug antibodies of JNJ-80948543 will be assessed.
Time frame: Up to 4 Years 3 months
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a best response of partial response (PR) or better.
Time frame: Up to 4 Years 3 months
Complete Response (CR) Rate
CR rate is defined as the percentage of participants who achieve a best response of CR.
Time frame: Up to 4 Years 3 months
Rate of VGPR or Better for Participants with Waldenstrom Macroglobulinemia (WM)
The response criteria planned to be used for participants with WM includes a category of VGPR, which is clinically understood to be better than PR but not as good as CR. For participants with WM, this rate is defined as the proportion of participants who achieve a best response of VGPR or better.
Time frame: Up to 4 Years 3 months
Time to Response (TTR)
TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR.
Time frame: Up to 4 Years 3 months
Duration of Response (DOR)
DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death.
Time frame: Up to 4 Years 3 months
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Texas Transplant Institute
San Antonio, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Macquarie University Hospital
Macquarie University, Australia
The Alfred Hospital
Melbourne, Australia
Linear Clinical Research Ltd
Nedlands, Australia
...and 19 more locations