JNJ-79635322
DrugJNJ-79635322 will be administered as SC injection.
NCT Number: NCT05652335
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
UZ Antwerpen, Edegem, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For participants with relapsed or refractory multiple myeloma:
For participants with previously treated AL amyloidosis:
Exclusion criteria
For participants with relapsed or refractory multiple myeloma:
For participants with previously treated AL amyloidosis:
JNJ-79635322 will be administered as SC injection.
Time frame: Up to 2 years 5 months
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 2 years 5 months
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Time frame: Up to 2 Years 5 months
Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.
Time frame: Up to 2 Years 5 months
Serum samples will be analyzed to determine concentrations of JNJ-79635322.
Time frame: Up to 2 Years 5 months
Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.
Time frame: Up to 2 Years 5 months
Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
Time frame: Up to 2 Years 5 months
TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for partial response (PR) or better as defined by IMWG 2016 response criteria.
Time frame: Up to 2 Years 5 months
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 response criteria, or death due to any cause, whichever occurs first.
Time frame: Up to 2 Years 5 months
TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by International Amyloidosis Consensus Criteria.
Time frame: Up to 2 Years 5 months
DOR is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per International Amyloidosis Consensus Criteria or death due to any cause, whichever occurs first.
Time frame: Up to 2 Years 5 months
Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Amyloidosis Consensus Criteria.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated AL Amyloidosis
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.
Published trials that share one or more normalized conditions with this study.
NCT07116616
Blood Protein Disorders, Cardiovascular Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT05519085
Blood Protein Disorders, Cardiovascular Diseases
Los Alamitos, California, United States
View Trial DetailsNCT05927571
Blood Protein Disorders, Cardiovascular Diseases
Camperdown, New South Wales, Australia
View Trial DetailsNCT07018050
Blood Protein Disorders, Cardiovascular Diseases
Tianjin, China
View Trial Details