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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/NCT03145909
Registration number
NCT03145909
Ethics application status
Date submitted
5/05/2017
Date registered
9/05/2017
Date last updated
29/11/2018
Titles & IDs
Public title
A Study Evaluating the Safety, Pharmacokinetics and Anti-Tumor Activity of ABBV-176 in Subjects With Advanced Solid Tumors Likely to Express Prolactin Receptor (PRLR)
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Scientific title
A Phase 1 Study Evaluating the Safety, Pharmacokinetics and Anti-Tumor Activity of ABBV-176 in Subjects With Advanced Solid Tumors Likely to Express Prolactin Receptor (PRLR)
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Secondary ID [1]
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2016-004597-18
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Secondary ID [2]
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M15-916
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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-176
Experimental: Dose Escalation Cohort - ABBV-176 will be administered via intravenous infusion at escalating dose levels until the maximum tolerated dose is reached.
Experimental: Expanded RPTD Cohort - ABBV-176 via intravenous administration in participants with breast cancer at the Recommended Phase Two Dose (RPTD) determined during the Dose Escalation Cohort
Treatment: Drugs: ABBV-176
Intravenous infusion
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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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Dose Escalation Cohort: Tmax of ABBV-176
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Assessment method [1]
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Time to Cmax (Tmax) of ABBV-176
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Timepoint [1]
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Up to approximately 57 days
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Primary outcome [2]
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Dose Escalation Cohort: AUC8 for ABBV-176
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Assessment method [2]
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AUC8 is the area under the plasma concentration-time curve from Time 0 to infinite time.
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Timepoint [2]
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Up to approximately 57 days
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Primary outcome [3]
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Dose Escalation Cohort: Terminal phase elimination rate constant (ß) for ABBV-176
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Assessment method [3]
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Terminal phase elimination rate constant (ß)
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Timepoint [3]
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Up to approximately 57 days
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Primary outcome [4]
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Dose Escalation Cohort: Recommended Phase 2 dose (RPTD) for ABBV-176
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Assessment method [4]
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The RPTD will be determined using available safety and pharmacokinetics data upon completion of the Dose Escalation Cohort.
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Timepoint [4]
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Minimum first cycle of dosing (up to 21 days)
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Primary outcome [5]
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Dose Escalation Cohort: Cmax of ABBV-176
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Assessment method [5]
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Maximum observed plasma concentration (Cmax) of ABBV-176.
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Timepoint [5]
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Up to approximately 57 days
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Primary outcome [6]
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Dose Escalation Cohort: Maximum tolerated dose (MTD) of ABBV-176
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Assessment method [6]
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MTD will be defined as the highest dose level at which less than or equal to 33% of participants experience a dose limiting toxicity.
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Timepoint [6]
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Minimum first cycle of dosing (up to 21 days)
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Primary outcome [7]
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Expanded Recommended Phase Two Dose (RPTD) Cohort: Objective Response Rate (ORR)
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Assessment method [7]
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ORR is defined as the proportion of participants with a response of partial response (PR) or better per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
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Timepoint [7]
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Up to approximately 2 years
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Primary outcome [8]
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Dose Escalation Cohort: AUCt for ABBV-176
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Assessment method [8]
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Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt) for ABBV-176.
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Timepoint [8]
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Up to approximately 57 days
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Primary outcome [9]
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Dose Escalation Cohort: t1/2 for ABBV-176
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Assessment method [9]
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Terminal elimination half-life (t1/2)
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Timepoint [9]
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Up to approximately 57 days
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Secondary outcome [1]
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Expanded RPTD Cohort: AUCt for ABBV-176
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Assessment method [1]
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Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt)
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Timepoint [1]
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Up to approximately 15 days
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Secondary outcome [2]
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Expanded RPTD Cohort: Tmax of ABBV-176
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Assessment method [2]
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Time to Cmax (Tmax) of ABBV-176
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Timepoint [2]
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Up to approximately 15 days
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Secondary outcome [3]
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Expanded RPTD Cohort: Overall Survival (OS)
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Assessment method [3]
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OS is defined as number of days from the date of the first dose to the date of death for all dosed subjects. For subjects who are not deceased, the data will be censored at the date of the last study visit, or the last know date to be alive, whichever is later.
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Timepoint [3]
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Up to 2 years after the last dose of study drug
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Secondary outcome [4]
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Expanded RPTD Cohort: Cmax of ABBV-176
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Assessment method [4]
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Maximum observed plasma concentration (Cmax) of ABBV-176.
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Timepoint [4]
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Up to approximately 15 days
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Secondary outcome [5]
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Expanded RPTD Cohort: Duration of Response (DOR)
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Assessment method [5]
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DOR is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first.
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Timepoint [5]
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Up to approximately 2 years
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Secondary outcome [6]
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Expanded RPTD Cohort: Terminal phase elimination rate constant (ß) for ABBV-176
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Assessment method [6]
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Terminal phase elimination rate constant (ß) for ABBV-176
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Timepoint [6]
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Up to approximately 15 days
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Secondary outcome [7]
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Expanded Recommended Phase Two Dose (RPTD) Cohort: Progression-Free Survival (PFS)
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Assessment method [7]
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PFS is defined as the time from the participant's first dose of study drug (Day 1) to the date of documented disease progression (per RECIST 1.1), or death due to any cause, whichever occurs first.
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Timepoint [7]
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Up to approximately 2 years
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Secondary outcome [8]
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Expanded RPTD Cohort: Change in ECOG Performance Status
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Assessment method [8]
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Change from baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
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Timepoint [8]
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Up to approximately 2 years
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Secondary outcome [9]
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Expanded RPTD Cohort: AUC8 for ABBV-176
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Assessment method [9]
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Area Under the Plasma Concentration-time Curve from Time 0 to infinite time (AUC8)
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Timepoint [9]
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Up to approximately 15 days
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Secondary outcome [10]
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Expanded RPTD Cohort: t1/2 for ABBV-176
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Assessment method [10]
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Terminal elimination half-life (t1/2) for ABBV-176
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Timepoint [10]
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Up to approximately 15 days
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Secondary outcome [11]
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Dose Escalation Cohort: Change from Baseline in QTcF
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Assessment method [11]
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QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline
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Timepoint [11]
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Up to approximately 47 days
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Eligibility
Key inclusion criteria
- Participant has histological confirmation of a locally advanced or metastatic solid
tumor of a type associated with Prolactin Receptor (PRLR) expression that has
progressed on prior treatment, is not amenable to treatment with curative intent, and
has no other therapy options known to provide clinical benefit or the subject is
ineligible for such therapies.
- Dose Escalation Cohort: must have breast cancer, colorectal cancer, adrenocortical
carcinoma, chromophobe renal cell carcinoma.
- Expanded Cohort: must have breast cancer.
- Participant must consent to provide the following for biomarker analyses:
- Dose Escalation Cohort: archived tumor tissue or fresh tumor biopsy.
- Expanded Cohort: archived tumor tissue and fresh tumor biopsy.
- Participant has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Participant has adequate bone marrow, renal, and hepatic function.
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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
- Participant received anticancer therapy including chemotherapy, immunotherapy,
radiotherapy, biologic, or any investigational therapy within 21 days before Study Day
1; participant received palliative radiotherapy or small molecule targeted anti-cancer
agents within 14 days of Study Day 1.
- Participant has prior exposure to any pyrrolobenzodiazopine-containing agent
- Participant has unresolved, clinically significant toxicities from prior anticancer
therapy, defined as greater than Grade 1 on Common Terminology for adverse events.
- Participant has clinically significant uncontrolled conditions.
- Participant has a history of major immunologic reaction to any Immunoglobulin G (IgG).
- Participant has received more than 4 prior lines of systemic cytotoxic therapy (not
including neo-adjuvant or adjuvant therapy).
- For prior cytotoxic therapy, treatment for 1 full cycle or less will not be
considered as prior therapy unless the patient experienced progression of disease
while on that therapy.
- Participant has a history of >= grade 3 AST, ALT, or bilirubin increase or has
extensive liver resection (i.e., left lobe resection).
- Participant has a history of cholecystitis (subject with history of cholecystectomy
will not be excluded), or has active gallbladder disease.
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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
Parallel
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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
Terminated
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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
3/07/2017
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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
27/11/2018
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Sample size
Target
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Accrual to date
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Final
19
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Sydney Children's Hospital /ID# 162917 - Randwick
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Recruitment hospital [2]
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Mater Misericordiae /ID# 162918 - South Brisbane
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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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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Country [2]
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United States of America
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State/province [2]
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California
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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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Connecticut
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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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Missouri
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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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New Jersey
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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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Utah
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Country [7]
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Denmark
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State/province [7]
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Hovedstaden
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Country [8]
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Spain
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State/province [8]
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Madrid
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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 maximum tolerated dose
(MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary
efficacy, and pharmacokinetic (PK) profile of ABBV-176 for participants with advanced solid
tumors likely to express Prolactin Receptor (PRLR). The study will consist of 2 cohorts: Dose
Escalation and Expanded Recommended Phase 2 Dose.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03145909
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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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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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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03145909
Download to PDF