JNJ-95566692
DrugJNJ-95566692 will be administered subcutaneously.
NCT Number: NCT07308132
The purpose of this study is to determine the putative recommended Phase 2 doses (RP2Ds) and optimal dose schedule(s) for JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) (Part 1: Dose Escalation) and to further characterize the safety and clinical activity of JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) at the putative RP2D(s) (Part 2: Dose Expansion).
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-95566692 will be administered subcutaneously.
JNJ-87801493 will be administered subcutaneously.
Time frame: Approximately 2 years and 8 months
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity for AEs will be specified as per: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and Grade 5 (death related to adverse event). SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Time frame: Approximately 2 years and 8 months
Number of participants with DLTs for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity.
Time frame: Approximately 2 years and 8 months
Serum concentration for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be assessed using a validated assay method.
Time frame: Approximately 2 years and 8 months
AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau).
Time frame: Approximately 2 years and 8 months
Cmax for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.
Time frame: Approximately 2 years and 8 months
Cmin for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.
Time frame: Approximately 2 years and 8 months
AUC(0-t) for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.
Time frame: Approximately 2 years and 8 months
Half-life (t1/2) for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.
Time frame: Approximately 2 years and 8 months
Tmax is the time to reach maximum observed serum concentration for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B).
Time frame: Approximately 2 years and 8 months
CL/F for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.
Time frame: Approximately 2 years and 8 months
V/F for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported.
Time frame: Approximately 2 years and 8 months
Participants with presence of antibodies binding to JNJ-95566692 in arm A and arm B will be reported.
Time frame: Approximately 2 years and 8 months
Participants with presence of antibodies binding to JNJ-87801493 in arm B will be reported.
Time frame: Approximately 2 years and 8 months
Overall response is defined as a best response of partial response (PR) or better as assessed by the investigator according to standard response criteria per Lugano.
Time frame: Approximately 2 years and 8 months
Complete response (CR) is defined as a best response of CR as assessed by the investigator according to standard response criteria per Lugano.
Time frame: Approximately 2 years and 8 months
TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better.
Time frame: Approximately 2 years and 8 months
DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease, initiation of a new systemic anti-cancer therapy or death.
Time frame: Approximately 2 years and 8 months
PFS is defined as the time from the date of first dose of study treatment to the date of first documented evidence of progressive disease (as defined in the disease-specific response criteria; unless) or death due to any cause, whichever occurs first.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
A Phase 1, First-in-Human Study of a Novel CD79bxCD20xCD3 Trispecific Antibody in B-Cell Non-Hodgkin Lymphoid Malignancies (NHLs)
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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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