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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02955251
Registration number
NCT02955251
Ethics application status
Date submitted
2/11/2016
Date registered
4/11/2016
Titles & IDs
Public title
A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors
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Scientific title
A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors
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Secondary ID [1]
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2016-001461-88
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Secondary ID [2]
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M15-819
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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:
Advanced Solid Tumors Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-428
Treatment: Drugs - Nivolumab
Experimental: Arm 1 - ABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle).
Experimental: Arm A, B, and C - Additional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428.
Experimental: Arm D - Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab.
Experimental: Arm 2 - ABBV-428 plus nivolumab.
Treatment: Drugs: ABBV-428
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
Treatment: Drugs: Nivolumab
Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.
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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 adverse events
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Assessment method [1]
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Timepoint [1]
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First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose
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Primary outcome [2]
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Recommended Phase 2 Dose (RPTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab
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Assessment method [2]
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If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-428 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.
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Timepoint [2]
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1 day of study drug administration within the 28-day cycle at the designated cohort dose
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Primary outcome [3]
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Area under the serum concentration-time curve (AUC) of ABBV-428
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Assessment method [3]
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Timepoint [3]
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Up to 30 days after a 24-month treatment period
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Primary outcome [4]
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Terminal half-life (t1/2) of ABBV-428
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Assessment method [4]
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Timepoint [4]
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Up to 30 days after a 24-month treatment period
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Primary outcome [5]
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Maximum observed serum concentration (Cmax) of ABBV-428
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Assessment method [5]
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Timepoint [5]
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Up to 30 days after a 24-month treatment period
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Primary outcome [6]
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Maximum tolerated dose (MTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab
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Assessment method [6]
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The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
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Timepoint [6]
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Up to 2 years
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Primary outcome [7]
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Time to Cmax (Tmax) of ABBV-428
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Assessment method [7]
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Timepoint [7]
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Up to 30 days after a 24-month treatment period
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Secondary outcome [1]
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Duration of Objective Response (DOR)
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Assessment method [1]
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DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first.
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Timepoint [1]
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Up to 30 days after a 24-month of treatment period
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Secondary outcome [2]
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Clinical benefit rate (CBR)
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Assessment method [2]
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CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment.
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Timepoint [2]
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Up to 30 days after a 24-month of treatment period
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Secondary outcome [3]
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Progression-Free Survival (PFS)
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Assessment method [3]
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PFS time is defined as the time from the first dose of ABBV-428 to disease progression or death, whichever occurs first
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Timepoint [3]
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Up to 30 days after a 24-month of treatment period
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Secondary outcome [4]
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Objective Response Rate (ORR)
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Assessment method [4]
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ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.
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Timepoint [4]
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Up to 30 days after a 24-month of treatment period
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Eligibility
Key inclusion criteria
* Participants must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
* Participants have adequate bone marrow, renal, hepatic and coagulation function.
* For all dose expansion arms, participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
* Participants in combination therapy cohorts must have an advanced solid tumor where the use of nivolumab is standard therapy.
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Minimum age
18
Years
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Maximum age
99
Years
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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
* Active or prior documented autoimmune disease in the last 2 years. Participants with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
* Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
* History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
* Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C. Participants who have a history of hepatitis B or C who have undetectable HBV DNA or HCV RNA after anti-viral therapy may be enrolled.
* Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis (or any other unresolved or symptomatic adverse event in the last 3 months) while receiving immunotherapy.
* Male participants who are considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
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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
Single group
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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
Completed
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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
18/11/2016
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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
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Actual
29/10/2019
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Sample size
Target
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Accrual to date
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Final
61
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Chris O'Brien Lifehouse /ID# 163131 - Camperdown
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Recruitment hospital [2]
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Northern Cancer Institute /ID# 163132 - St Leonards
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2065 - St Leonards
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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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Arizona
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United States of America
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California
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United States of America
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State/province [3]
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Illinois
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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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Pennsylvania
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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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South Carolina
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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France
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State/province [7]
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Gironde
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Country [8]
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France
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Ile-de-France
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Country [9]
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France
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Provence-Alpes-Cote-d Azur
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Country [10]
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France
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State/province [10]
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Rhone
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Country [11]
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Taiwan
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State/province [11]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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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
This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.
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Trial website
https://clinicaltrials.gov/study/NCT02955251
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Trial related presentations / publications
Luke JJ, Barlesi F, Chung K, Tolcher AW, Kelly K, Hollebecque A, Le Tourneau C, Subbiah V, Tsai F, Kao S, Cassier PA, Khasraw M, Kindler HL, Fang H, Fan F, Allaire K, Patel M, Ye S, Chao DT, Henner WR, Hayflick JS, McDevitt MA, Fong L. Phase I study of ABBV-428, a mesothelin-CD40 bispecific, in patients with advanced solid tumors. J Immunother Cancer. 2021 Feb;9(2):e002015. doi: 10.1136/jitc-2020-002015.
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Public notes
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Contacts
Principal investigator
Name
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AbbVie Inc.
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Address
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AbbVie
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Country
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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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Address
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Fax
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02955251