Relapsed or Refractory Multiple Myeloma

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).

A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma

Relapsed/ Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma

Relapse Multiple Myeloma

Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma (RRMM)

Multiple Myeloma

Kahler's Disease

Blood Cancer

Hematologic Neoplasms

Hematologic Malignancies

Hematology

Hematological Malignancies

JNJ-87562761

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-87562761 in Relapsed/Refractory Multiple Myeloma

DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.

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.

Number of participants with clinically significant abnormal laboratory values (hematology or chemistry) will be reported.

Serum samples will be analyzed to determine concentrations of JNJ-87562761.

PK parameters for JNJ-87562761 will be evaluated.

Number of participants with presence of anti-JNJ-87562761 antibodies will be reported.

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.

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.

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.

sCR is defined as the percentage of participants who achieve a best response of sCR as assessed by IMWG 2016 response criteria.

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.

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.

Participants will receive JNJ-87562761 during the Part 1 (Dose escalation) to determine the recommended phase 2 dose (RP2D) regimen(s). The dose will be escalated sequentially until the RP2D regimen(s) have been identified. In Part 2 (Dose expansion) participants will receive JNJ-87562761 at the RP2D regimen(s) determined in Part 1.

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).

Princess Margaret Hospital

Seoul National University Hospital

Asan Medical Center

Samsung Medical Center

The Catholic University of Korea Seoul St Marys Hospital

Hosp. Univ. Germans Trias I Pujol

Hosp Clinic de Barcelona

Hosp Univ Fund Jimenez Diaz

Clinica Univ. de Navarra

Hosp Clinico Univ de Salamanca

DLTs are specific adverse events and are defined as any of the following: high grade
non-hematologic toxicity or hematologic toxicity.

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.

Number of participants with clinically significant abnormal laboratory values (hematology
or chemistry) will be reported.

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.

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.

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.

sCR is defined as the percentage of participants who achieve a best response of sCR as
assessed by IMWG 2016 response criteria.

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.

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.

Participants will receive JNJ-87562761 during the Part 1 (Dose escalation) to determine
the recommended phase 2 dose (RP2D) regimen(s). The dose will be escalated sequentially
until the RP2D regimen(s) have been identified. In Part 2 (Dose expansion) participants
will receive JNJ-87562761 at the RP2D regimen(s) determined in Part 1.

A Study of JNJ-87562761 in Participants With Relapsed or Refractory Multiple Myeloma

Trials at a glance

Trials at a glance