Lymphoma, Non-Hodgkin
Conditions
Brief summary
The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).
Interventions
DRUGJNJ-80948543
JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.
DRUGJNJ-75348780
JNJ-75348780 will be administered as SC injection.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic documentation of diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy * Participants must have measurable disease as defined by the appropriate disease response criteria * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug * Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 24 hours before the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Exclusion criteria
* Known active central nervous system involvement (CNS) or leptomeningeal involvement * Prior solid-organ transplantation * Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug * Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade \<= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2) * Clinically significant pulmonary compromise defined as the need for supplemental oxygen to maintain adequate oxygenation * Evidence of clinically significant and/or symptomatic infection (viral, bacterial, or fungal) at the time of study drug initiation. Anti-microbial treatment for infection must be discontinued at least 7 days before the first dose of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose-limiting Toxicity (DLT) | Up to 1 year and 10 months | Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for \>=7 days or Grade \>3 with Grade \>=2 bleeding; Grade 4 anemia). |
| Number of Participants with Adverse Events (AEs) | Up to 1 year and 10 months | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of JNJ-80948543 and JNJ-75348780 | Up to 1 year and 10 months | Serum Concentration for JNJ-80948543 and JNJ-75348780 will be reported. |
| Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780 | Up to 1 year and 10 months | AUC tau is defined as area under the serum concentration-time curve during a dosing interval for JNJ-80948543 and JNJ-75348780. |
| Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780 | Up to 1 year and 10 months | Cmax for JNJ-80948543 and JNJ-75348780 will be reported. |
| Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780 | Up to 1 year and 10 months | Tmax is the time to reach maximum observed serum concentration for JNJ-80948543 and JNJ-75348780. |
| Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543 and JNJ-75348780 | Up to 1 year and 10 months | Number of participants with presence of anti-drug antibodies of JNJ-80948543 and JNJ-75348780 will be assessed. |
| Overall Response Rate (ORR) | Up to 1 year and 10 months | ORR is defined as the percentage of participants who have a best response of partial response (PR) or better as assessed by the investigator based on standard response criteria. |
| Complete Response Rate (CRR) | Up to 1 year and 10 months | CR is defined as the percentage of participants who achieve a best response of CR as assessed by the investigator based on standard response criteria. |
| Duration of Response (DoR) | Up to 1 year and 10 months | DOR is defined as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death as assessed by the investigator based on standard response criteria. |
Countries
Australia, Spain, Taiwan, United Kingdom
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed