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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
JNJ-79635322 will be administered as SC injection.
City of Hope
Duarte, California, United States
RECRUITINGCity of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGColorado Blood Cancer Institute
Denver, Colorado, United States
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 2 years 5 months
Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity
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
Part 2: Number of Participants with Abnormalities in Laboratory Values
Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.
Time frame: Up to 2 Years 5 months
Serum Concentration of JNJ-79635322
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
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 as Defined by International Myeloma Working Group (IMWG) 2016 Response Criteria
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
Time to Response (TTR) as Defined by IMWG 2016 Response Criteria
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
Duration of Response (DOR) as Defined by IMWG 2016 Response Criteria
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
Part 2: Time to Response (TTR) as Defined by International Amyloidosis Consensus Criteria
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
Part 2: Duration of Response (DOR) as Defined by International Amyloidosis Consensus Criteria
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
Part 2: Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Amyloidosis Consensus Criteria
Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Amyloidosis Consensus Criteria.
Time frame: Up to 2 Years 5 months
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Icahn School of Medicine at Mt. Sinai
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGLevine Cancer Institute
Charlotte, North Carolina, United States
RECRUITINGUniversity of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGUZ Antwerpen
Edegem, Belgium
RECRUITING...and 19 more locations