Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002666-12 | EudraCT Number |
Not provided
Not provided
Not provided
Business, strategic, and development considerations and not due to any safety concerns
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the First-In-Human study was to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.
This was a FIH, open-label, phase I/Ib, multi-center study, which consisted of a dose escalation part of JBH492 as a single agent, followed by an expansion part. The escalation part was conducted in patients with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and Non-Hodgkin's Lymphoma (r/r NHL). Once the maximum tolerated dose/recommended dose (MTD/RD) of single agent JBH492 was determined, the study continued with an expansion part with single agent JBH492 in defined patient populations.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JBH492 single agent | Experimental | Patients with R/R CLL or NHL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JBH492 | Drug | Anti-CCR7 antibody-drug conjugate (ADC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of dose limiting toxicities (DLTs) | 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. | 32 months |
| Incidence and severity of Adverse Events (AEs) | 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. | 32 months |
| Incidence and severity of Serious Adverse Events (SAEs) | A Serious adverse event (SAE) is defined as one of the following:
| 32 months |
| Number of patients with dose interruptions | Tolerability measured by the number of subjects who have interruptions of study treatment and reason for interruptions | 32 months |
| Number of patients with dose reductions | Tolerability measured by the number of subjects who have reductions of study treatment and reason for reductions | 32 months |
| Dose intensity | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | 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). | 32 months |
| Best overall response (BOR) |
Not provided
Inclusion Criteria:
For patients with CLL:
• Confirmed diagnosis of chronic lymphocytic leukemia (CLL)
For patients with NHL:
Exclusion Criteria, applicable to both CLL and NHL:
Other inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Helsinki | FIN-00029 | Finland | |||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| Link to study results | View source |
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 32 months |
The best overall response (BOR) is the best reponse recorded in a patient from the start of treatment until disease progression. |
| 32 months |
| Duration of Response (DOR) | 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. | 32 months |
| Progression Free Survival (PFS) | 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 | 32 months |
| Pharmacokinetics (PK) parameter AUClast | 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) | 32 months |
| PK parameter AUCinf | The AUC from time zero to infinity (mass × time × volume-1) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4) | 32 months |
| PK parameter AUCtau | 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) | 32 months |
| PK parameter Cmax and Cmin | The maximum (peak) and minimum observed serum drug concentration (mass × volume-1) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4) | 32 months |
| PK parameter Tmax | The time to reach maximum (peak) serum drug concentration (time) for four analytes (total antibody, total antibody-drug-conjugate, DM4, sDM4) | 32 months |
| PK parameter T1/2 | 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) | 32 months |
| Incidence of anti-JBH492 antibodies | Number of subjects with anti-JBH492 antibodies (Anti-Drug Antibodies) | 32 months |
| Dresden |
| 01307 |
| Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Tel Aviv | 6423906 | Israel |
| Novartis Investigative Site | Chuo Ku | Tokyo | 104 0045 | Japan |
| Novartis Investigative Site | Singapore | 169608 | Singapore |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |