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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02988960




Registration number
NCT02988960
Ethics application status
Date submitted
8/12/2016
Date registered
12/12/2016
Date last updated
12/03/2019

Titles & IDs
Public title
A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors
Scientific title
A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
2016-002219-16
Secondary ID [2] 0 0
M15-862
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-927
Treatment: Drugs - ABBV-927
Treatment: Drugs - ABBV-181

Experimental: Expansion Arm C - Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-927 plus ABBV-181.

Experimental: Expansion Arm A - Additional participants (with Head and Neck Squamous Cell Carcinoma (HNSCC), or non-small cell lung cancer [NSCLC]) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-927.

Experimental: Escalating Arm 2 - ABBV-927 via intratumoral administration at escalating dose levels in 28-day dosing cycles (initially 2 doses per cycle).

Experimental: Escalating Arm 1 - ABBV-927 via intravenous administration at escalating dose levels in 28-day dosing cycles (initially 2 doses per cycle).

Experimental: Expansion Arm B - Additional participants (with HNSCC) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-927 plus ABBV-181.

Experimental: Escalation Arm 3 - ABBV-927 via intravenous administration at escalating dose levels (initially 2 doses per cycle) in combination with ABBV-181 via intravenous administration.

Experimental: Escalation Arm 4 - ABBV-927 via intratumoral administration at escalating dose levels (initially 2 doses per cycle) in combination with ABBV-181 via intravenous administration.


Treatment: Drugs: ABBV-927
Intravenous

Treatment: Drugs: ABBV-927
Intratumoral

Treatment: Drugs: ABBV-181
Intravenous

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

Outcomes
Primary outcome [1] 0 0
Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 - The MTD and the RPTD of ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study. Once the RPTD has been determined, the dose expansion portion will begin.
Timepoint [1] 0 0
Up to 8 weeks
Primary outcome [2] 0 0
Time to Cmax (Tmax) of ABBV-927 - Time to Cmax (Tmax) of ABBV-927
Timepoint [2] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [3] 0 0
Maximum observed serum concentration (Cmax) of ABBV-927 - Maximum observed serum concentration (Cmax) of ABBV-927
Timepoint [3] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [4] 0 0
Terminal half-life (t1/2) of ABBV-927 - Terminal half-life (t1/2) of ABBV-927
Timepoint [4] 0 0
Up to 4 weeks after participant's first dose
Primary outcome [5] 0 0
Area under the serum concentration-time curve (AUC) of ABBV-927 - Area under the serum concentration-time curve (AUC) of ABBV-927
Timepoint [5] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [6] 0 0
Time to Cmax (Tmax) of ABBV-181 - Time to Cmax (Tmax) of ABBV-181
Timepoint [6] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [7] 0 0
Maximum observed serum concentration (Cmax) of ABBV-181 - Maximum observed serum concentration (Cmax) of ABBV-181
Timepoint [7] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [8] 0 0
Terminal half-life (t1/2) of ABBV-181 - Terminal half-life (t1/2) of ABBV-181
Timepoint [8] 0 0
Up to 4 weeks after participant's first dose
Primary outcome [9] 0 0
Area under the serum concentration-time curve (AUC) of ABBV-181 - Area under the serum concentration-time curve (AUC) of ABBV-181
Timepoint [9] 0 0
Up to 12 weeks after participant's first dose
Secondary outcome [1] 0 0
Clinical benefit rate (CBR, defined as the percentage of participants with a confirmed partial, complete response, or stable disease for at least 24 weeks to the treatment) - 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 [1] 0 0
Up to 30 days after and up to 24-month of treatment period
Secondary outcome [2] 0 0
Duration of objective response (DOR) - DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Timepoint [2] 0 0
Up to 30 days after and up to 24-month of treatment period
Secondary outcome [3] 0 0
Objective response rate (ORR) - ORR is defined as the proportion of participants with a confirmed partial or complete response to the treatment
Timepoint [3] 0 0
Up to 30 days after and up to 24-month of treatment period
Secondary outcome [4] 0 0
Progression-free survival (PFS) - PFS time is defined as the time from the first dose of ABBV-927 to disease progression or death, whichever occurs first.
Timepoint [4] 0 0
Up to 30 days after and up to 24-month of treatment period

Eligibility
Key inclusion criteria
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
to 1.

- Participants have adequate bone marrow, kidney and liver function.

- Participants with a history of chronic heart failure or significant cardiovascular
disease must have an echocardiogram or multigated acquisition scan indicating left
ventricular ejection fraction greater than or equal to 45% within 28 days prior to the
first dose of study drug.

- Participants must have creatinine clearance greater than or equal to 50 mL/min as
measured by 24-hour urine or estimated by the Cockcroft-Gault formula.

- Participants must have total bilirubin less than or equal to 1.5 times the upper limit
of normal (ULN), and aspartate aminotransferase and alanine aminotransferase less than
or equal to 2.5 times ULN.

- Participants in all monotherapy arms 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 in all combination therapy arms must have recurrent or metastatic NSCLC
and previously received platinum-based therapy and progressed either during or after
anti-programmed death ligand 1 (PDL1)-based therapy. In addition, participants must
have received only one prior immunotherapy.

- The Sponsor may decide to limit the specific tumor types selected or treatment
settings for specific arms based on evidence gathered.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant must not have an active or prior documented autoimmune disease in the last
2 years.

- Participant must not have current or prior use of immunosuppressive medication within
14 days prior to the first dose (with certain exceptions).

- Participant must not have a history of primary immunodeficiency, bone marrow
transplantation, chronic lymphocytic leukemia, solid organ transplantation, previous
clinical diagnosis of tuberculosis, inflammatory bowel disease, interstitial lung
disease, or immune-mediated pneumonitis.

- Participant must not have a history of a coagulopathy or a platelet disorder.

- Participant must not have a prior grade greater than or equal to 3 immune-mediated
neurotoxicity or pneumonitis while receiving immunotherapy.

- Participant must not have a known uncontrolled malignancy of the central nervous
system.

- Participants in all combination therapy arms must not have a history of exposure to an
immunotherapy experiencing an immune-mediated adverse event that required permanent
discontinuation of the immunotherapy.

- Female participants must not be pregnant, breastfeeding or considering becoming
pregnant 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.

- Male participants must not be 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.

- Participant is judged by the investigator to have evidence of hemolysis.

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
Recruiting
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)
VIC
Recruitment hospital [1] 0 0
Peninsula & South Eastern Haem /ID# 164372 - Frankston
Recruitment hospital [2] 0 0
Austin Health /ID# 171189 - Melbourne
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
France
State/province [9] 0 0
Gironde
Country [10] 0 0
France
State/province [10] 0 0
Herault
Country [11] 0 0
France
State/province [11] 0 0
Ile-de-France
Country [12] 0 0
France
State/province [12] 0 0
Rhone
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul Teugbyeolsi
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Spain
State/province [16] 0 0
Majadahonda
Country [17] 0 0
Spain
State/province [17] 0 0
Valencia

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and
pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or
recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as
combination therapy with ABBV-181 in participants with advanced solid tumors.
Trial website
https://clinicaltrials.gov/show/NCT02988960
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
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02988960