The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.
JNJ-75348780 will be administered as SC injection.
Concord Hospital
Concord, Australia
St Vincents Hospital Melbourne
Fitzroy, Australia
Macquarie University Hospital
North Ryde, Australia
Number of Participants with Dose-limiting Toxicity (DLT)
Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for \>=7 days or Grade \>3 with Grade \>=2 bleeding; Grade 4 anemia).
Time frame: Up to 1 year and 10 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 1 year and 10 months
Serum Concentration of JNJ-80948543 and JNJ-75348780
Serum Concentration for JNJ-80948543 and JNJ-75348780 will be reported.
Time frame: Up to 1 year and 10 months
Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780
AUC tau is defined as area under the serum concentration-time curve during a dosing interval for JNJ-80948543 and JNJ-75348780.
Time frame: Up to 1 year and 10 months
Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780
Cmax for JNJ-80948543 and JNJ-75348780 will be reported.
Time frame: Up to 1 year and 10 months
Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780
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Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp. Clinic de Barcelona
Barcelona, Spain
Inst. Cat. Doncologia-H Duran I Reynals
L'Hospitalet de Llobregat, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
...and 1 more locations
Tmax is the time to reach maximum observed serum concentration for JNJ-80948543 and JNJ-75348780.
Time frame: Up to 1 year and 10 months
Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543 and JNJ-75348780
Number of participants with presence of anti-drug antibodies of JNJ-80948543 and JNJ-75348780 will be assessed.
Time frame: Up to 1 year and 10 months
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a best response of partial response (PR) or better as assessed by the investigator based on standard response criteria.
Time frame: Up to 1 year and 10 months
Complete Response Rate (CRR)
CR is defined as the percentage of participants who achieve a best response of CR as assessed by the investigator based on standard response criteria.
Time frame: Up to 1 year and 10 months
Duration of Response (DoR)
DOR is defined as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death as assessed by the investigator based on standard response criteria.
Time frame: Up to 1 year and 10 months