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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02955251




Registration number
NCT02955251
Ethics application status
Date submitted
2/11/2016
Date registered
4/11/2016
Date last updated
7/11/2019

Titles & IDs
Public title
A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors
Scientific title
A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
2016-001461-88
Secondary ID [2] 0 0
M15-819
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-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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events
Timepoint [1] 0 0
First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose
Primary outcome [2] 0 0
Recommended Phase 2 Dose (RPTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab - 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.
Timepoint [2] 0 0
1 day of study drug administration within the 28-day cycle at the designated cohort dose
Primary outcome [3] 0 0
Area under the serum concentration-time curve (AUC) of ABBV-428
Timepoint [3] 0 0
Up to 30 days after a 24-month treatment period
Primary outcome [4] 0 0
Terminal half-life (t1/2) of ABBV-428
Timepoint [4] 0 0
Up to 30 days after a 24-month treatment period
Primary outcome [5] 0 0
Maximum observed serum concentration (Cmax) of ABBV-428
Timepoint [5] 0 0
Up to 30 days after a 24-month treatment period
Primary outcome [6] 0 0
Maximum tolerated dose (MTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab - 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.
Timepoint [6] 0 0
Up to 2 years
Primary outcome [7] 0 0
Time to Cmax (Tmax) of ABBV-428
Timepoint [7] 0 0
Up to 30 days after a 24-month treatment period
Secondary outcome [1] 0 0
Duration of Objective Response (DOR) - DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Timepoint [1] 0 0
Up to 30 days after a 24-month of treatment period
Secondary outcome [2] 0 0
Clinical benefit rate (CBR) - 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.
Timepoint [2] 0 0
Up to 30 days after a 24-month of treatment period
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) - PFS time is defined as the time from the first dose of ABBV-428 to disease progression or death, whichever occurs first
Timepoint [3] 0 0
Up to 30 days after a 24-month of treatment period
Secondary outcome [4] 0 0
Objective Response Rate (ORR) - ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.
Timepoint [4] 0 0
Up to 30 days after a 24-month of treatment period

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

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
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse /ID# 163131 - Camperdown
Recruitment hospital [2] 0 0
Northern Cancer Institute /ID# 163132 - St Leonards
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
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
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
France
State/province [7] 0 0
Gironde
Country [8] 0 0
France
State/province [8] 0 0
Ile-de-France
Country [9] 0 0
France
State/province [9] 0 0
Provence-Alpes-Cote-d Azur
Country [10] 0 0
France
State/province [10] 0 0
Rhone
Country [11] 0 0
Taiwan
State/province [11] 0 0
Tainan
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taipei

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02955251
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

Summary results
Other publications