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A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02988960
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Cancer Drug: ABBV-927 Drug: ABBV-181 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : April 16, 2019
Estimated Study Completion Date : April 17, 2021

Resource links provided by the National Library of Medicine


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

Drug: ABBV-181
Intravenous

Experimental: Expansion Arm A
Additional participants (with squamous cell carcinoma of the head and neck [SCCHN], pancreatic adenocarcinoma, or non-small cell lung cancer [NSCLC]) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-927.
Drug: ABBV-927
Intravenous

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

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

Experimental: Expansion Arm B
Additional participants (with cutaneous melanoma or SCCHN) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-927.
Drug: ABBV-927
Intratumoral

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.
Drug: ABBV-927
Intravenous

Drug: ABBV-181
Intravenous




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 [ Time Frame: Up to 8 weeks ]
    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.

  2. Time to Cmax (Tmax) of ABBV-927 [ Time Frame: Up to 12 weeks after participant's first dose ]
    Time to Cmax (Tmax) of ABBV-927

  3. Maximum observed serum concentration (Cmax) of ABBV-927 [ Time Frame: Up to 12 weeks after participant's first dose ]
    Maximum observed serum concentration (Cmax) of ABBV-927

  4. Terminal half-life (t1/2) of ABBV-927 [ Time Frame: Up to 4 weeks after participant's first dose ]
    Terminal half-life (t1/2) of ABBV-927

  5. Area under the serum concentration-time curve (AUC) of ABBV-927 [ Time Frame: Up to 12 weeks after participant's first dose ]
    Area under the serum concentration-time curve (AUC) of ABBV-927

  6. Time to Cmax (Tmax) of ABBV-181 [ Time Frame: Up to 12 weeks after participant's first dose ]
    Time to Cmax (Tmax) of ABBV-181

  7. Maximum observed serum concentration (Cmax) of ABBV-181 [ Time Frame: Up to 12 weeks after participant's first dose ]
    Maximum observed serum concentration (Cmax) of ABBV-181

  8. Terminal half-life (t1/2) of ABBV-181 [ Time Frame: Up to 4 weeks after participant's first dose ]
    Terminal half-life (t1/2) of ABBV-181

  9. Area under the serum concentration-time curve (AUC) of ABBV-181 [ Time Frame: Up to 12 weeks after participant's first dose ]
    Area under the serum concentration-time curve (AUC) of ABBV-181


Secondary Outcome Measures :
  1. 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) [ Time Frame: Up to 30 days after and up to 24-month of treatment period ]
    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.

  2. Duration of objective response (DOR) [ Time Frame: Up to 30 days after and up to 24-month of treatment period ]
    DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.

  3. Objective response rate (ORR) [ Time Frame: Up to 30 days after and up to 24-month of treatment period ]
    ORR is defined as the proportion of participants with a confirmed partial or complete response to the treatment

  4. Progression-free survival (PFS) [ Time Frame: Up to 30 days after and up to 24-month of treatment period ]
    PFS time is defined as the time from the first dose of ABBV-927 to disease progression or death, whichever occurs first.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988960


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
United States, California
The Angeles Clinic and Researc /ID# 156324 Recruiting
Los Angeles, California, United States, 90025
United States, Illinois
University of Chicago /ID# 155264 Recruiting
Chicago, Illinois, United States, 60637-1443
United States, Massachusetts
Massachusetts General Hospital /ID# 155267 Recruiting
Boston, Massachusetts, United States, 02114
United States, North Carolina
Carolina BioOncology Institute /ID# 155265 Recruiting
Huntersville, North Carolina, United States, 28078
United States, Tennessee
Tennessee Oncology-Sarah Cannon Research Institute /ID# 158654 Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Univ TX, MD Anderson /ID# 155263 Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Virginia Cancer Specialists /ID# 155266 Recruiting
Fairfax, Virginia, United States, 22031
Australia, Victoria
Peninsula & South Eastern Haem /ID# 164372 Recruiting
Frankston, Victoria, Australia, 3199
Austin Health /ID# 171189 Recruiting
Melbourne, Victoria, Australia, 3084
Canada, Ontario
Princess Margaret Cancer Centr /ID# 200819 Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
France
Institut Bergonie /ID# 162665 Not yet recruiting
Bordeaux, Gironde, France, 33000
Institut Regional du Cancer /ID# 163609 Not yet recruiting
Montpellier CEDEX 5, Herault, France, 34298
Institut Gustave Roussy /ID# 162666 Not yet recruiting
Villejuif, Ile-de-France, France, 94805
Centre Leon Berard /ID# 162663 Not yet recruiting
Lyon CEDEX 08, Rhone, France, 69373
Korea, Republic of
Yonsei University Health System, Severance Hospital /ID# 166292 Not yet recruiting
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Seoul National University Hospital /ID# 166291 Not yet recruiting
Seoul, Korea, Republic of, 03080
Spain
Hospital Fundacion Jimenez Dia /ID# 200128 Not yet recruiting
Madrid, Spain, 28040
Hosp Univ Madrid Sanchinarro /ID# 200127 Not yet recruiting
Madrid, Spain, 28050
Hosp Univ Puerta de Hierro /ID# 200129 Not yet recruiting
Majadahonda, Spain, 28222
Hospital Universitario La Fe /ID# 200975 Not yet recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02988960     History of Changes
Other Study ID Numbers: M15-862
2016-002219-16 ( EudraCT Number )
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Non-small cell lung cancer (NSCLC)
Squamous cell carcinoma of the head and neck (SCCHN)
Advanced solid tumor
Cancer
Pancreatic adenocarcinoma
Cutaneous melanoma