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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05424822
Registration number
NCT05424822
Ethics application status
Date submitted
15/06/2022
Date registered
21/06/2022
Date last updated
23/05/2024
Titles & IDs
Public title
A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
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Scientific title
A Phase 1, First-in-human Study of JNJ-80948543, a T-cell Redirecting Antibody, in Participants With NHL and CLL
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Secondary ID [1]
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2022-000685-18
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Secondary ID [2]
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CR109174
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Non-Hodgkin
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Leukemia, Lymphocytic, Chronic, B-Cell
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-80948543
Experimental: Part A: Dose Escalation - Participants will receive JNJ-80948543 by subcutaneous (SC) administration to determine the putative recommended Phase 2 dose (RP2D) and dosing schedule(s) based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens.
Experimental: Part B: Cohort Expansion - Participants will receive JNJ-80948543 by SC administration.
Treatment: Drugs: JNJ-80948543
JNJ-80948543 will be administered as SC injection.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Dose-limiting Toxicity (DLT)
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Assessment method [1]
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Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
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Timepoint [1]
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Up to 2 Years 5 months
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Primary outcome [2]
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Number of Participants with Adverse Events (AEs)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 2 Years 5 months
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Primary outcome [3]
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Number of Participants with AE by Severity
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Assessment method [3]
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Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded as per american society for transplantation and cellular therapy (ASTCT).
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Timepoint [3]
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Up to 2 Years 5 months
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Secondary outcome [1]
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Serum Concentration of JNJ-80948543
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Assessment method [1]
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Serum samples will be analyzed to determine concentrations of JNJ-80948543 using a validated, specific, and sensitive method.
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Timepoint [1]
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Up to 2 Years 5 months
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Secondary outcome [2]
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Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543
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Assessment method [2]
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Number of participants with presence of anti-drug antibodies of JNJ-80948543 will be assessed.
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Timepoint [2]
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Up to 2 Years 5 months
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Secondary outcome [3]
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Overall Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the percentage of participants who have a best response of partial response (PR) or better.
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Timepoint [3]
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Up to 2 Years 5 months
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Secondary outcome [4]
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Complete Response (CR) Rate
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Assessment method [4]
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CR rate is defined as the percentage of participants who achieve a best response of CR.
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Timepoint [4]
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Up to 2 Years 5 months
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Secondary outcome [5]
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Rate of VGPR or Better for Participants with Waldenstrom Macroglobulinemia (WM)
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Assessment method [5]
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The response criteria planned to be used for participants with WM includes a category of VGPR, which is clinically understood to be better than PR but not as good as CR. For participants with WM, this rate is defined as the proportion of participants who achieve a best response of VGPR or better.
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Timepoint [5]
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Up to 2 Years 5 months
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Secondary outcome [6]
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Time to Response (TTR)
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Assessment method [6]
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TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR.
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Timepoint [6]
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Up to 2 Years 5 months
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Secondary outcome [7]
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Duration of Response (DOR)
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Assessment method [7]
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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 or death.
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Timepoint [7]
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Up to 2 Years 5 months
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Eligibility
Key inclusion criteria
- Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chronic
lymphocytic leukemia (CLL) requiring therapy.
All participants must have relapsed or refractory disease with no other approved therapies
available that would be more appropriate in the investigator's judgment.
B-cell NHL as defined per the 2016 world health organization (WHO) classification. In
addition, the following disease-specific criteria outlined below must be met If diffuse
large B-cell lymphoma (DLBCL) or other high-Grade B-cell lymphoma: Received, or not
eligible for high-dose chemotherapy and autologous stem cell transplantation with curative
intent or deemed not eligible or fit for an alternative 2nd line therapy. Participants may
be eligible if relapsing after chimeric antigen receptors (CAR-T) cell treatment or while
waiting for a CAR-T cell treatment.
If transformed lymphoma from low Grade B-cell malignancies: Received or not a candidate for
an approved first-line regimen for DLBCL and received or not eligible for high-dose
chemotherapy and autologous stem cell transplantation with curative intent.
If follicular lymphoma (FL) (all grades): Previously treated with a minimum of 2 prior
lines of systemic therapy, with at least one prior line containing an anti-CD20 antibody.
If mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) (including nodal,
extranodal/MALT, and splenic MZL subtypes): Previously treated with at least 2 lines of
systemic therapy. H.pylori-positive gastric MALT lymphoma must have failed prior H. pylori
eradication therapy as one of their prior lines .
Waldenstrom macroglobulinemia (WM): Previously treated with at least 1 line of systemic
therapy.
small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL/SLL): Relapsed or refractory
with at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor (BTK)
inhibitor or a BCL2 inhibitor, if eligible. In addition for part B Participants must have
measurable disease as defined by the appropriate disease response criteria
- Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
- Cardiac parameters within the following range: corrected QT interval (QTc intervals
corrected using Fridericia's formula [QTcF]) less than or equal to (<=) 480
milliseconds based on the average of triplicate assessments performed no more than 5
(plus minus [+-] 3) minutes apart
- A female participant of childbearing potential must have a negative highly sensitive
serum pregnancy test (beta- human chorionic gonadotropin) at screening and must agree
to further serum or urine pregnancy tests prior to the first dose, during the study
and until 3 months after the last dose of study treatment
- A female participant must agree not to be pregnant, breastfeeding, or planning to
become pregnant while enrolled in this study or within 3 months after the last dose of
study intervention
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Known active central nervous system (CNS) involvement; Lymphoma with CNS involvement
may be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts if
approved by the study evaluation team (SET)
- 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, particularly the need for supplemental
oxygen use to maintain adequate oxygenation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/10/2026
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Macquarie University Hospital - Macquarie University
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Recruitment hospital [3]
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Linear Clinical Research Ltd - Nedlands
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Recruitment hospital [4]
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Scientia Clinical Research - Randwick
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Recruitment postcode(s) [1]
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2109 - Macquarie University
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment postcode(s) [4]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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New York
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Country [3]
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United States of America
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State/province [3]
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Tennessee
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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United States of America
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State/province [5]
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Washington
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Country [6]
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China
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State/province [6]
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Guangzhou
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Country [7]
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China
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State/province [7]
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Tianjin
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Country [8]
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China
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State/province [8]
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Wuhan
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Country [9]
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Denmark
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State/province [9]
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Copenhagen
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Denmark
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State/province [10]
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Odense
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Country [11]
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France
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State/province [11]
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Lille Cedex
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Country [12]
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France
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Paris
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Country [13]
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France
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State/province [13]
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Toulouse Cedex 9
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Country [14]
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Israel
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State/province [14]
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Haifa
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Israel
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Jerusalem
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Country [16]
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Israel
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State/province [16]
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Tel Aviv
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Poland
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State/province [17]
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Gdansk
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Poland
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Skorzewo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to characterize safety and to determine the putative recommended
Phase 2 dose(s) (RP2D[s]) and optimal dosing schedule(s) of JNJ-80948543 in Part A (Dose
Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in
Part B (Cohort Expansion).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05424822
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Phone
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844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05424822
Download to PDF