JNJ-79635322
DrugJNJ-79635322 will be administered subcutaneously.
NCT Number: NCT06768489
The primary purpose of this study for Part 1 (Dose Escalation) is to identify the safe effective dose (recommended Phase 2 doses [RP2Ds]) and schedule for JNJ-79635322 treatment regimen in combination with daratumumab with or without lenalidomide or with pomalidomide; and for Part 2 (Dose Expansion) is to further characterize the safety and tolerability of JNJ-79635322 combination treatment regimens at selected RP2D(s).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Monash Medical Centre, Clayton, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-79635322 will be administered subcutaneously.
Daratumumab will be administered subcutaneously.
Pomalidomide will be administered orally.
Lenalidomide will be administered orally.
Time frame: Up to 28 days
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 3 Years and 3 months
An AE 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 3 Years and 3 months
Participants with clinically significant laboratory abnormalities (hematology and chemistry) will be reported.
Time frame: Up to 3 Years and 3 months
Overall response rate is defined as percentage of participants who have a partial response (PR) or better evaluated by the investigator as per international myeloma working group (IMWG) 2016 criteria.
Time frame: Up to 3 Years and 3 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), as per IMWG 2016 response criteria, or death due to progression, whichever occurs first.
Time frame: Up to 3 Years and 3 months
TTR is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better as defined by IMWG 2016 response criteria.
Time frame: Up to 3 Years and 3 months
Serum samples will be analyzed to determine concentrations of JNJ-79635322 and daratumumab.
Time frame: Up to 3 Years and 3 months
AUCinf for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
AUC(0-t) for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
AUCtau for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Cmax for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
T1/2 for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Tmax for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
CL/F for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Vss/F for JNJ-79635322 and daratumumab will be reported.
Time frame: Up to 3 Years and 3 months
Participants with anti-drug antibodies to JNJ-79635322 and daratumumab will be reported.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
A Phase 1b Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for 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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