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JBH492

The purpose of the First-In-Human study is to assess safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.

This is a FIH, open-label, phase I/Ib, multi-center study, which consists of a dose escalation part of JBH492 as a single agent, followed by an expansion part. The escalation part will be conducted in patients with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and Non-Hodgkin's Lymphoma (r/r NHL). Once the MTD/RD of single agent JBH492 is determined, the study will continue with an expansion part with single agent JBH492 in defined patient populations

Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL

A Phase I/Ib Open-label, Multi-center Dose Escalation Study of JBH492 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)

A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value that occurs during the first cycle of treatment with JBH492 and meets any of the protocol specified criteria, unless incontrovertibly related to underlying disease, intercurrent illness or concomitant medications.

An adverse event ( treatment emergent) is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.

A Serious adverse event (SAE) is defined as one of the following:

* Is fatal or life-threatening
* Results in persistent or significant disability/incapacity
* Constitutes a congenital anomaly/birth defect
* Is medically significant
* Requires inpatient hospitalization or prolongation of existing hospitalization.

Tolerability measured by the number of subjects who have interruptions of study treatment and reason for interruptions

Tolerability measured by the number of subjects who have reductions of study treatment and reason for reductions

Tolerability measured by the dose intensity of study drug, Relative Dose intensity for subjects with non-zero duration of exposure is computed as the ratio of dose intensity and planned dose intensity

The overall response rate (ORR), defined as the proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR), as per local review and according to the iwCLL guideline (CLL) or Lugano Classification (NHL).

The best overall response (BOR) is the best reponse recorded in a patient from the start of treatment until disease progression.

The time between the date of first documented response (CR or PR) and the date of first documented progression or death due to underlying cancer.

PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause

The area under the plasma concentration-time curve (AUC) of JBH492 from time zero to the last measurable concentration sampling time (tlast) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)

The AUC from time zero to infinity (mass × time × volume-1) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)

The AUC calculated to the end of a dosing interval (tau) (mass × time × volume-1) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)

The maximum (peak) and minimum observed serum drug concentration (mass × volume-1) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)

The time to reach maximum (peak) serum drug concentration (time) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)

The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4)

Number of subjects with anti-JBH492 antibodies (Anti-Drug Antibodies)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL	NCT04240704	Non-Hodgkins Ly... Chronic Lymphoc...	JBH492	18 Years -	Novartis
Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL	NCT04240704	Non-Hodgkins Ly... Chronic Lymphoc...	JBH492	18 Years -	Novartis
Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL	NCT04240704	Non-Hodgkins Ly... Chronic Lymphoc...	JBH492	18 Years -	Novartis

Spots Global Cancer Trial Database for jbh492

Every month we try and update this database with for jbh492 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for jbh492

Every month we try and update this database with for jbh492 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for jbh492 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.