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A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02955251
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Cancer Drug: ABBV-428 Drug: Nivolumab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors
Actual Study Start Date : November 18, 2016
Estimated Primary Completion Date : April 8, 2019
Estimated Study Completion Date : January 7, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Arm 1
ABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle).
Drug: ABBV-428
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.

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.
Drug: ABBV-428
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.

Experimental: Arm D
Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab.
Drug: ABBV-428
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.

Drug: Nivolumab
Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.
Other Name: OPDIVO

Experimental: Arm 2
ABBV-428 plus nivolumab.
Drug: ABBV-428
ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.

Drug: Nivolumab
Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.
Other Name: OPDIVO




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose ]
  2. Recommended Phase 2 Dose (RPTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab [ Time Frame: 1 day of study drug administration within the 28-day cycle at the designated cohort dose ]
    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.

  3. Area under the serum concentration-time curve (AUC) of ABBV-428 [ Time Frame: Up to 30 days after a 24-month treatment period ]
  4. Terminal half-life (t1/2) of ABBV-428 [ Time Frame: Up to 30 days after a 24-month treatment period ]
  5. Maximum observed serum concentration (Cmax) of ABBV-428 [ Time Frame: Up to 30 days after a 24-month treatment period ]
  6. Maximum tolerated dose (MTD) of ABBV-428 when administered as monotherapy or in combination with nivolumab [ Time Frame: Up to 2 years ]
    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.

  7. Time to Cmax (Tmax) of ABBV-428 [ Time Frame: Up to 30 days after a 24-month treatment period ]

Secondary Outcome Measures :
  1. Duration of Objective Response (DOR) [ Time Frame: Up to 30 days after a 24-month of treatment period ]
    DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first.

  2. Clinical benefit rate (CBR) [ Time Frame: Up to 30 days after a 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.

  3. Progression-Free Survival (PFS) [ Time Frame: Up to 30 days after a 24-month of treatment period ]
    PFS time is defined as the time from the first dose of ABBV-428 to disease progression or death, whichever occurs first

  4. Objective Response Rate (ORR) [ Time Frame: Up to 30 days after a 24-month of treatment period ]
    ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

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): NCT02955251


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

Locations
United States, Arizona
HonorHealth Research Institute - Pima /ID# 155461 Recruiting
Scottsdale, Arizona, United States, 85258-2345
United States, California
UC Davis Comp Cancer Ctr /ID# 154439 Recruiting
Sacramento, California, United States, 95817
United States, Illinois
University of Chicago /ID# 154440 Recruiting
Chicago, Illinois, United States, 60637-1443
United States, Pennsylvania
Fox Chase Cancer Center /ID# 170665 Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Greenville Hospital System /ID# 154437 Recruiting
Greenville, South Carolina, United States, 29605
United States, Texas
MD Anderson Cancer Center /ID# 154441 Recruiting
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics /ID# 154442 Recruiting
San Antonio, Texas, United States, 78229
Australia, New South Wales
Chris O'Brien Lifehouse /ID# 163131 Recruiting
Camperdown, New South Wales, Australia, 2050
Northern Cancer Institute /ID# 163132 Recruiting
St Leonards, New South Wales, Australia, 2065
France
Institut Bergonie /ID# 202391 Not yet recruiting
Bordeaux, Gironde, France, 33000
Institut Curie /ID# 162258 Recruiting
Paris CEDEX 05, Ile-de-France, France, 75248
Institut Gustave Roussy /ID# 162257 Recruiting
Villejuif, Ile-de-France, France, 94805
Hopital de la Timone /ID# 162256 Recruiting
Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France, 13385
Centre Leon Berard /ID# 168072 Recruiting
Lyon CEDEX 08, Rhone, France, 69373
Taiwan
National Cheng Kung University Hospital /ID# 169035 Not yet recruiting
Tainan City, Tainan, Taiwan, 70403
National Taiwan Univ Hosp /ID# 169034 Not yet recruiting
Taipei City, Taipei, Taiwan, 10002
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02955251     History of Changes
Other Study ID Numbers: M15-819
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 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:
Cancer
Neoplasm
Advanced solid tumor
Nivolumab
Non-small cell lung cancer (NSCLC)
Non-squamous NSCLC
Ovarian cancer

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs