Clinical Trial - NCT02988960

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

Recruiting

Sponsor: AbbVie

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02988960

Protocol Info

Short Description: Phase 1 ABBV-927 in Advanced Solid Tumors
Long Description: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927, an Immunotherapy, in Subjects with Advanced Solid Tumors
MGH Status: Open
Sponsor: AbbVie
Disease Program: Head & Neck

Next Steps


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Purpose

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 Title Intervention Phase
Advanced Solid Tumors Cancer ABBV-927 ABBV-927 ABBV-181 Phase 1
Study Type Interventional
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

Primary Outcome Measures

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] [Designated as safety issue: ]

Time to Cmax (Tmax) of ABBV-927 [Time Frame: Up to 12 weeks after participant's first dose] [Designated as safety issue: ]

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

Terminal-Phase Elimination Rate Constant (ß) of ABBV-927 [Time Frame: Up to 12 weeks after participant's first dose] [Designated as safety issue: ]

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

Area under the serum concentration-time curve (AUCt) of ABBV-927 [Time Frame: Up to 12 weeks after participant's first dose] [Designated as safety issue: ]

Time to Cmax (Tmax) of ABBV-181 [Time Frame: Up to 12 weeks after participant's first dose] [Designated as safety issue: ]

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

Terminal-Phase Elimination Rate Constant (ß) of ABBV-181 [Time Frame: Up to 12 weeks after participant's first dose] [Designated as safety issue: ]

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

Area under the serum concentration-time curve (AUCt) of ABBV-181 [Time Frame: Up to 12 weeks after participant's first dose] [Designated as safety issue: ]

Number of Participants with Adverse Events [Time Frame: Up to 30 days after and up to 24-month of treatment period] [Designated as safety issue: ]


Secondary Outcome Measures

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] [Designated as safety issue: ]

Duration of objective response (DOR) [Time Frame: Up to 30 days after and up to 24-month of treatment period] [Designated as safety issue: ]

Objective response rate (ORR) [Time Frame: Up to 30 days after and up to 24-month of treatment period] [Designated as safety issue: ]

Progression-free survival (PFS) [Time Frame: Up to 30 days after and up to 24-month of treatment period] [Designated as safety issue: ]

Estimated Enrollment: 216
Study Start Date: February 2017
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: November 2021
Arms Assigned Interventions

Experimental:Escalating Arm 1: ABBV-927

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

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-181
Intravenous

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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02988960

Locations

  • United States, California
    • The Angeles Clinic and Researc /ID# 156324 Los Angeles, California, United States, 90025
  • United States, Illinois
    • University of Chicago DCAM /ID# 155264 Chicago, Illinois, United States, 60637-1443
  • United States, Massachusetts
    • Massachusetts General Hospital /ID# 155267 Boston, Massachusetts, United States, 02114
  • United States, North Carolina
    • Carolina BioOncology Institute /ID# 155265 Huntersville, North Carolina, United States, 28078
  • United States, Tennessee
    • Tennessee Oncology-Nashville Centennial /ID# 158654 Nashville, Tennessee, United States, 37203-1632
  • United States, Texas
    • University of Texas MD Anderson Cancer Center /ID# 155263 Houston, Texas, United States, 77030
  • United States, Virginia
    • Virginia Cancer Specialists /ID# 155266 Fairfax, Virginia, United States, 22031
  • Australia, Victoria
    • Peninsula & South Eastern Haem /ID# 164372 Frankston, Victoria, Australia, 3199
    • Austin Health /ID# 171189 Melbourne, Victoria, Australia, 3084
  • Canada, Ontario
    • Princess Margaret Cancer Centre /ID# 200819 Toronto, Ontario, Canada, M5G 2M9
  • France, Gironde
    • Institut Bergonie /ID# 162665 Bordeaux, Gironde, France, 33000
  • France, Herault
    • Institut Regional du Cancer /ID# 163609 Montpellier CEDEX 5, Herault, France, 34298
  • France, Ile-de-France
    • Gustave Roussy /ID# 162666 Villejuif, Ile-de-France, France, 94805
  • France, Rhone
    • Centre Leon Berard /ID# 162663 Lyon CEDEX 08, Rhone, France, 69373
  • Japan, Chiba
    • National Cancer Center Hospital East /ID# 216870 Kashiwa-shi, Chiba, Japan, 277-8577
  • Japan, Tokyo
    • National Cancer Center Hospital /ID# 217758 Chuo-ku, Tokyo, Japan, 104-0045
  • Korea, Republic of, Seoul Teugbyeolsi
    • Yonsei University Health System, Severance Hospital /ID# 166292 Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
  • Korea, Republic of,
    • Seoul National University Hospital /ID# 166291 Seoul, , Korea, Republic of, 03080
  • Spain, Madrid
    • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 200129 Majadahonda, Madrid, Spain, 28222
  • Spain,
    • Hospital Universitario Fundacion Jimenez Diaz /ID# 200128 Madrid, , Spain, 28040
    • Hospital Universitario HM Sanchinarro /ID# 200127 Madrid, , Spain, 28050
    • Hospital Universitario y Politecnico La Fe /ID# 200975 Valencia, , Spain, 46026

Sponsors and Collaborators

AbbVie

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02988960
Other Study ID Numbers: 2016-002219-16
Study First Received:
Last Updated:
Health Authority:

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:

Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on October 14, 2020