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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02988960
Ethics application status
Date submitted
8/12/2016
Date registered
12/12/2016

Titles & IDs
Public title
A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants 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: Escalating Arm 1: ABBV-927 - Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.

Experimental: Escalating Arm 2: ABBV-927 - Participants with solid tumors will receive escalating intratumoral (IT) doses of ABBV-927.

Experimental: Escalating Arm 3: ABBV-927+ABBV-181 - Participants with Non-Small Cell Lung Cancer (NSCLC) will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.

Experimental: Escalating Arm 4: ABBV-927+ABBV-181 - Participants with Head and Neck Squamous Cell Carcinoma (HNSCC) will receive escalating IT doses of ABBV-927 and IV doses of ABBV-181.

Experimental: Escalating Arm 5 (Japan): ABBV-927 - Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.

Experimental: Escalating Arm 6 (Japan): ABBV-927+ABBV-181 - Participants with solid tumors will receive escalating IV doses of ABBV-927 and IV doses of ABBV-181.

Experimental: Expansion Arm A: ABBV-927 - Additional participants with HNSCC or NSCLC will receive intravenous (IV) doses of ABBV-927.

Experimental: Expansion Arm B: ABBV-927+ABBV-181 - Additional participants with HNSCC will receive IT doses of ABBV-927 and IV doses of ABBV-181.

Experimental: Expansion Arm C: ABBV-927+ABBV-181 - Additional participants with NSCLC will receive IV doses of ABBV-927 and IV doses of ABBV-181.


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
Timepoint [1] 0 0
Up to 8 weeks
Primary outcome [2] 0 0
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
Timepoint [3] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [4] 0 0
Terminal-Phase Elimination Rate Constant (ß) of ABBV-927
Timepoint [4] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [5] 0 0
Terminal half-life (t1/2) of ABBV-927
Timepoint [5] 0 0
Up to 4 weeks after participant's first dose
Primary outcome [6] 0 0
Area under the serum concentration-time curve (AUCt) of ABBV-927
Timepoint [6] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [7] 0 0
Time to Cmax (Tmax) of ABBV-181
Timepoint [7] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [8] 0 0
Maximum observed serum concentration (Cmax) of ABBV-181
Timepoint [8] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [9] 0 0
Terminal-Phase Elimination Rate Constant (ß) of ABBV-181
Timepoint [9] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [10] 0 0
Terminal half-life (t1/2) of ABBV-181
Timepoint [10] 0 0
Up to 4 weeks after participant's first dose
Primary outcome [11] 0 0
Area under the serum concentration-time curve (AUCt) of ABBV-181
Timepoint [11] 0 0
Up to 12 weeks after participant's first dose
Primary outcome [12] 0 0
Number of Participants with Adverse Events
Timepoint [12] 0 0
Up to 30 days after and up to 24-month of treatment period
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)
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)
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)
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)
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 HNSCC or 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
Sex
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 clinically significant uncontrolled condition(s) including but not limited to the following: uncontrolled hypertension; symptomatic congestive heart failure; unstable angina pectoris or cardiac arrhythmia including atrial fibrillation.
* Participant must not have a history of coagulopathy or a platelet disorder associated with significant clinical risk of thromboembolic event in the judgement of the investigator, or major thromboembolic event within 6 months prior to the first dose of study treatment.
* 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.
* For Japan only, participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis).

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/03/2025
Actual
Sample size
Target
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peninsula Oncology Centre /ID# 164372 - Frankston
Recruitment hospital [2] 0 0
Austin Health /ID# 171189 - Heidelberg
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
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
Rhone
Country [12] 0 0
France
State/province [12] 0 0
Val-de-Marne
Country [13] 0 0
Japan
State/province [13] 0 0
Chiba
Country [14] 0 0
Japan
State/province [14] 0 0
Tokyo
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul Teugbyeolsi
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Spain
State/province [18] 0 0
Valencia

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)?
No
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/NCT02988960