JNJ-87562761
DrugJNJ-87562761 will be administered.
NCT Number: NCT06604715
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).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Princess Margaret Hospital, Toronto, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-87562761 will be administered.
Time frame: up to approximately 3 years
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
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
Number of participants with clinically significant abnormal laboratory values (hematology or chemistry) will be reported.
Time frame: up to approximately 3 years
Serum samples will be analyzed to determine concentrations of JNJ-87562761.
Time frame: up to approximately 3 years
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 will be reported.
Time frame: up to approximately 3 years
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
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
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
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
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
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.
Janssen Research & Development, LLC
Industry
A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-87562761 in Relapsed/Refractory Multiple Myeloma
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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