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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02988960
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : March 23, 2020
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Non-Randomized
Intervention Model: Sequential 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 : June 30, 2020
Estimated Study Completion Date : October 10, 2022

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

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.
Drug: ABBV-927
Intravenous

Drug: ABBV-181
Intravenous
Other Name: Budigalimab

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.
Drug: ABBV-927
Intratumoral

Drug: ABBV-181
Intravenous
Other Name: Budigalimab

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.
Drug: ABBV-927
Intratumoral

Drug: ABBV-181
Intravenous
Other Name: Budigalimab

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

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.
Drug: ABBV-927
Intravenous

Drug: ABBV-181
Intravenous
Other Name: Budigalimab

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.
Drug: ABBV-927
Intravenous

Drug: ABBV-181
Intravenous
Other Name: Budigalimab

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

Experimental: Escalating Arm 1: ABBV-927
Participants with solid tumors will receive escalating intravenous (IV) doses of ABBV-927.
Drug: ABBV-927
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 (AUCt) of ABBV-927 [ Time Frame: Up to 12 weeks after participant's first dose ]
    Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) 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 (AUCt) of ABBV-181 [ Time Frame: Up to 12 weeks after participant's first dose ]
    Area under the serum concentration-time curve from time zero to the time of last measurable concentration (AUCt) 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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, 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.
  • For Japan only, participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis).

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
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02988960    
Other Study ID Numbers: M15-862
2016-002219-16 ( EudraCT Number )
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
ABBV-927
ABBV-181
Budigalimab
Additional relevant MeSH terms:
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Neoplasms