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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03145909




Registration number
NCT03145909
Ethics application status
Date submitted
5/05/2017
Date registered
9/05/2017

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)
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)
Secondary ID [1] 0 0
2016-004597-18
Secondary ID [2] 0 0
M15-916
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Escalation Cohort: Tmax of ABBV-176
Timepoint [1] 0 0
Up to approximately 57 days
Primary outcome [2] 0 0
Dose Escalation Cohort: AUC8 for ABBV-176
Timepoint [2] 0 0
Up to approximately 57 days
Primary outcome [3] 0 0
Dose Escalation Cohort: Terminal phase elimination rate constant (ß) for ABBV-176
Timepoint [3] 0 0
Up to approximately 57 days
Primary outcome [4] 0 0
Dose Escalation Cohort: Recommended Phase 2 dose (RPTD) for ABBV-176
Timepoint [4] 0 0
Minimum first cycle of dosing (up to 21 days)
Primary outcome [5] 0 0
Dose Escalation Cohort: Cmax of ABBV-176
Timepoint [5] 0 0
Up to approximately 57 days
Primary outcome [6] 0 0
Dose Escalation Cohort: Maximum tolerated dose (MTD) of ABBV-176
Timepoint [6] 0 0
Minimum first cycle of dosing (up to 21 days)
Primary outcome [7] 0 0
Expanded Recommended Phase Two Dose (RPTD) Cohort: Objective Response Rate (ORR)
Timepoint [7] 0 0
Up to approximately 2 years
Primary outcome [8] 0 0
Dose Escalation Cohort: AUCt for ABBV-176
Timepoint [8] 0 0
Up to approximately 57 days
Primary outcome [9] 0 0
Dose Escalation Cohort: t1/2 for ABBV-176
Timepoint [9] 0 0
Up to approximately 57 days
Secondary outcome [1] 0 0
Expanded RPTD Cohort: AUCt for ABBV-176
Timepoint [1] 0 0
Up to approximately 15 days
Secondary outcome [2] 0 0
Expanded RPTD Cohort: Tmax of ABBV-176
Timepoint [2] 0 0
Up to approximately 15 days
Secondary outcome [3] 0 0
Expanded RPTD Cohort: Overall Survival (OS)
Timepoint [3] 0 0
Up to 2 years after the last dose of study drug
Secondary outcome [4] 0 0
Expanded RPTD Cohort: Cmax of ABBV-176
Timepoint [4] 0 0
Up to approximately 15 days
Secondary outcome [5] 0 0
Expanded RPTD Cohort: Duration of Response (DOR)
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Expanded RPTD Cohort: Terminal phase elimination rate constant (ß) for ABBV-176
Timepoint [6] 0 0
Up to approximately 15 days
Secondary outcome [7] 0 0
Expanded Recommended Phase Two Dose (RPTD) Cohort: Progression-Free Survival (PFS)
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Expanded RPTD Cohort: Change in ECOG Performance Status
Timepoint [8] 0 0
Up to approximately 2 years
Secondary outcome [9] 0 0
Expanded RPTD Cohort: AUC8 for ABBV-176
Timepoint [9] 0 0
Up to approximately 15 days
Secondary outcome [10] 0 0
Expanded RPTD Cohort: t1/2 for ABBV-176
Timepoint [10] 0 0
Up to approximately 15 days
Secondary outcome [11] 0 0
Dose Escalation Cohort: Change from Baseline in QTcF
Timepoint [11] 0 0
Up to approximately 47 days

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/11/2018
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Sydney Children's Hospital /ID# 162917 - Randwick
Recruitment hospital [2] 0 0
Mater Misericordiae /ID# 162918 - South Brisbane
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Denmark
State/province [7] 0 0
Hovedstaden
Country [8] 0 0
Spain
State/province [8] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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/NCT03145909