Clinical Trial - NCT02099058

A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Subjects With Advanced Solid Tumors

Recruiting

Sponsor: AbbVie

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02099058

Protocol Info

Short Description: Phase 1/1b Study of ABBV-399 in Advanced Solid Tumors
Long Description: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects with Advanced Solid Tumors
MGH Status: Open
Sponsor: AbbVie
Disease Program: Phase I

Next Steps


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Purpose

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in subjects with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.
Condition Title Intervention Phase
Advanced Solid Tumors Cancer Osimertinib Nivolumab Telisotuzumab vedotin Telisotuzumab vedotin Erlotinib Phase 1
Study Type Interventional
Official Title A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

Primary Outcome Measures

Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) [Time Frame: Up to 24 months] [Designated as safety issue: ]

Maximum observed plasma concentration (Cmax) [Time Frame: Up to 24 months] [Designated as safety issue: ]

Time to Cmax (Tmax) [Time Frame: Up to 24 months] [Designated as safety issue: ]

Terminal elimination half life [Time Frame: Up to 24 months] [Designated as safety issue: ]


Secondary Outcome Measures

Objective response rate (ORR) [Time Frame: Up to 24 months] [Designated as safety issue: ]

Progression free survival (PFS) [Time Frame: Up to 24 months] [Designated as safety issue: ]

Duration of overall response (DOR) [Time Frame: Up to 24 months] [Designated as safety issue: ]

Estimated Enrollment: 225
Study Start Date: January 2014
Estimated Study Completion Date: February 2022
Estimated Primary Completion Date: February 2022
Arms Assigned Interventions

Experimental:Arm E (Telisotuzumab vedotin plus Osimertinib)

Telisotuzumab vedotin to be evaluated with Osimertinib.
Drug:Osimertinib
It is administered orally everyday.

Experimental:Arm D (Telisotuzumab vedotin plus Nivolumab)

Telisotuzumab vedotin to be evaluated with Nivolumab.
Drug:Telisotuzumab vedotin
It is administered by infusion in 28-day dosing cycles.

Experimental:Monotherapy Telisotuzumab vedotin (21-day dosing cycles)

Telisotuzumab vedotin will be administered at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin.

Experimental:Arm A (Telisotuzumab vedotin plus Erlotinib)

Telisotuzumab vedotin to be evaluated with Erlotinib.
Drug:Erlotinib
It is administered orally everyday.

Experimental:Monotherapy Telisotuzumab vedotin (28-day dosing cycles)

Telisotuzumab vedotin will be administered at escalating dose levels in 28-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate Telisotuzumab vedotin.

Eligibility

Ages Eligible for Study: 99 Years-99 Years

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Participant must have advanced Non-Small Cell Lung Cancer (NSCLC) that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  • Participant must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
  • Participant has fresh and/or archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue confirmed available for analyses.
  • Participant has adequate bone marrow, renal, and hepatic function.
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.
  • Participants in the combination therapy arms A and D must be eligible to receive erlotinib, or nivolumab per most current prescribing information, or at the discretion of the Investigator.
  • Participants in the combination therapy Arm E must satisfy following criteria.
  • Participant must have metastatic NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) known to be sensitive to osimertinib, including del19, L858R, G719X or L861Q.
  • Participant must have discontinued osimertinib due to disease progression.
  • Participant must have available post-progression tumor tissue for central c-Met immunohistochemistry (IHC) testing.

Exclusion Criteria:

  • Participant has received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days or herbal therapy within 7 days prior to the first dose of ABBV-399.
  • Participant has uncontrolled metastases to the central nervous system (CNS) based on head CT or MRI. Subjects with brain metastases may be eligible 2 weeks after definitive therapy to all known sites of CNS disease provided they are asymptomatic and either off or on a non-increasing dose (in last 2 weeks) of systemic steroids and not on anticonvulsants for seizure activity directly related to progressive CNS metastases.
  • Participant has history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis.
  • Participant has unresolved clinically significant adverse events >= Grade 2 from prior anticancer therapy, except for alopecia or anemia.
  • Participant has had major surgery within 21 days prior to the first dose of ABBV-399.
  • Participant has a clinically significant condition(s) described in the protocol.
  • Participant has history of major immunologic reaction to any Immunoglobulin G (IgG) containing agent.
  • Participants enrolled on the combination therapy phase must satisfy the above exclusion criteria and also the following:
  • Participants may not receive ABBV-399 in combination with osimertinib, erlotinib or nivolumab if they have any medical condition which in the opinion of the Investigator places the participant at an unacceptably high risk for toxicities from the combination.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099058

Locations

  • United States, Arizona
    • Scottsdale Healthcare /ID# 123761 Scottsdale, Arizona, United States, 85258-4566
  • United States, California
    • Cedars-Sinai Medical Center /ID# 216836 Beverly Hills, California, United States, 90211
    • City of Hope /ID# 153759 Duarte, California, United States, 91010
    • University of California, Los Angeles /ID# 148295 Los Angeles, California, United States, 90095
    • UC Irvine /ID# 165107 Orange, California, United States, 92868
    • UC Davis Comprehensive Cancer Center - Main /ID# 129805 Sacramento, California, United States, 95817
  • United States, Colorado
    • Univ of Colorado Cancer Center /ID# 123759 Aurora, Colorado, United States, 80045
  • United States, Illinois
    • University of Chicago /ID# 136995 Chicago, Illinois, United States, 60637-1443
    • Ingalls Memorial Hosp /ID# 165876 Harvey, Illinois, United States, 60426
  • United States, Massachusetts
    • Massachusetts General Hospital /ID# 129804 Boston, Massachusetts, United States, 02114
    • Dana-Farber Cancer Institute /ID# 168782 Boston, Massachusetts, United States, 02215
  • United States, Michigan
    • Henry Ford Health System /ID# 149857 Detroit, Michigan, United States, 48202
    • Herbert Herman Cancer Center /ID# 149858 Lansing, Michigan, United States, 48912
  • United States, Minnesota
    • Virginia Piper Cancer Institut /ID# 217418 Minneapolis, Minnesota, United States,
  • United States, Missouri
    • Washington University-School of Medicine /ID# 143798 Saint Louis, Missouri, United States, 63110
  • United States, North Carolina
    • Duke University Medical Center /ID# 123763 Durham, North Carolina, United States, 27710-3000
  • United States, Tennessee
    • Tennessee Oncology, PLLC /ID# 129802 Nashville, Tennessee, United States, 37203
  • United States, Texas
    • Mary Crowley Cancer Research /ID# 123760 Dallas, Texas, United States, 75230
    • University of Texas MD Anderson Cancer Center /ID# 154648 Houston, Texas, United States, 77030
  • United States, Virginia
    • Virginia Cancer Specialists /ID# 165708 Fairfax, Virginia, United States, 22031
  • Belgium,
    • UZ Antwerpen /ID# 170118 Edegem, , Belgium, 2650
  • Finland,
    • Tays Keskussairaala /ID# 165065 Tampere, , Finland, 33520
  • France, Ile-de-France
    • Gustave Roussy /ID# 132747 Villejuif, Ile-de-France, France, 94805
  • France, Provence-Alpes-Cote-d Azur
    • Hopital de la Timone /ID# 151570 Marseille CEDEX 05, Provence-Alpes-Cote-d Azur, France, 13385
  • Italy, Emilia-Romagna
    • IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 164077 Meldola, Emilia-Romagna, Italy, 47014
  • Japan, Chiba
    • National Cancer Center Hospital East /ID# 217570 Kashiwa-shi, Chiba, Japan, 277-8577
  • Japan, Tokyo
    • National Cancer Center Hospital /ID# 217571 Chuo-ku, Tokyo, Japan, 104-0045
  • Korea, Republic of,
    • Severance Hospital /ID# 217333 Seoul, , Korea, Republic of, 03722
    • Asan Medical Center /ID# 217334 Seoul, , Korea, Republic of, 05505
  • Taiwan, Taichung
    • China Medical University Hosp /ID# 217494 Taichung City, Taichung, Taiwan, 40447
  • Taiwan, Tainan
    • National Cheng Kung University Hospital /ID# 167175 Tainan City, Tainan, Taiwan, 70403
  • Taiwan, Taipei
    • National Taiwan University Hospital /ID# 167173 Taipei City, Taipei, Taiwan, 100
  • Taiwan,
    • Taipei Veterans General Hosp /ID# 217392 Taipei City, , Taiwan, 11217

Sponsors and Collaborators

AbbVie

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02099058
Other Study ID Numbers: 2014-003154-14
Study First Received:
Last Updated:
Health Authority:

Keywords provided by AbbVie:

Cancer

Advanced Solid Tumor

Neoplasm

Additional relevant MeSH terms:

Neoplasms

Nivolumab

Erlotinib Hydrochloride

Osimertinib

Antibodies, Monoclonal

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 April 09, 2020