The purpose of this study is to determine the recommended phase 2 dose(s) (RP2D\[s\]) of JNJ-87562761 in Part 1 (dose escalation), and to determine the safety and tolerability at RP2D in Part 2 (dose expansion) in participants with multiple myeloma (MM) whose disease has come back after treatment (relapsed) or hasn't responded to treatment (refractory).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
JNJ-87562761 will be administered.
Princess Margaret Hospital
Toronto, Ontario, Canada
RECRUITINGJewish General Hospital
Montreal, Quebec, Canada
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
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 approximately 3 years
Part 1 and 2: Number of Participants with Adverse Events (AEs)
Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: up to approximately 3 years
Part 2: Number of Participants with Clinically Significant Abnormal Laboratory Values
Number of participants with clinically significant abnormal laboratory values (hematology or chemistry) will be reported.
Time frame: up to approximately 3 years
Serum Concentration of JNJ-87562761
Serum samples will be analyzed to determine concentrations of JNJ-87562761.
Time frame: up to approximately 3 years
Pharmacokinetic (PK) Parameters of JNJ-87562761
PK parameters for JNJ-87562761 will be evaluated.
Time frame: up to approximately 3 years
Number of Participants with Presence of Anti-JNJ-87562761 Antibodies
Number of participants with presence of anti-JNJ-87562761 antibodies will be reported.
Time frame: up to approximately 3 years
Percentage of Participants with Response
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Seoul National University Hospital
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGThe Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea
RECRUITINGHosp. Univ. Germans Trias I Pujol
Badalona, Spain
RECRUITINGHosp Clinic de Barcelona
Barcelona, Spain
RECRUITINGHosp Univ Fund Jimenez Diaz
Madrid, Spain
RECRUITINGClinica Univ. de Navarra
Pamplona, Spain
RECRUITING...and 5 more locations
Overall response is defined as a best response of partial response (PR) or better as assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
Time frame: up to approximately 3 years
Percentage of Participants Who Achieve Very Good Partial Response (VGPR) or Better
VGPR or better response is defined as the percentage of participants who achieve a best response of VGPR or better as assessed by IMWG 2016 response criteria.
Time frame: up to approximately 3 years
Percentage of Participants Who Achieve Complete Response (CR) or Better
CR or better response is defined as percentage of participants who achieve a best response of CR or better as assessed by IMWG 2016 response criteria.
Time frame: up to approximately 3 years
Percentage of Participants Who Achieve Stringent Complete Response (sCR)
sCR is defined as the percentage of participants who achieve a best response of sCR as assessed by IMWG 2016 response criteria.
Time frame: up to approximately 3 years
Duration of Response (DOR)
DOR is defined for participants who achieve a response of PR or better as the time from the first efficacy evaluation at which the participant met all criteria for a response of PR or better to the time of first documented evidence of progressive disease or death, assessed by IMWG 2016 response criteria.
Time frame: up to approximately 3 years
Time to Response (TTR)
TTR is defined for participants who achieve a response of PR or better as the time from the first dose of study drug to the time of the first efficacy evaluation at which the participant met all criteria for a response of PR or better, assessed by IMWG 2016 response criteria.
Time frame: up to approximately 3 years