Clinical Trial - NCT02099058

       

A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants 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


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




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 participants 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

Number of Participants with Adverse Events [Time Frame: Up to 24 Months] [Designated as safety issue: ]

Recommended Phase 2 Dose (RPTD) of ABBV-399 when Administered as Monotherapy and in Combination with Osimertinib, Erlotinib or Nivolumab [Time Frame: Up to 24 Months] [Designated as safety issue: ]

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

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

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: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.

Experimental:Arm A (Telisotuzumab vedotin plus Erlotinib)

Telisotuzumab vedotin to be evaluated with Erlotinib.
Drug:Erlotinib
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:Arm E (Telisotuzumab vedotin plus Osimertinib)

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

Eligibility

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

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 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 at baseline.
  • • Participants in the combination therapy arms A and D must be eligible to receive erlotinib, or nivolumab per most locally approved labeling, or at the discretion of the Investigator.
  • • Participants in the combination therapy Arm E must satisfy following criteria.
  • • Participant must have metastatic/locally advanced nonsquamous NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) del19 or L858R, with or without T790M mutation, and none of the EGFR mutations known to be resistant to osimertinib.
  • • Participant must have received at least 1 but no more than 2 prior regimens, one of which must have contained osimertinib. Participant must have had disease progression while on osimertinib. Only 1 prior regimen may have contained chemotherapy.
  • • Participant must have available post-progression tumor tissue for central c-Met immunohistochemistry (IHC) testing.
  • • Participant has adequate bone marrow function.

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. Participants 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.
  • • History of major immunologic reaction to any Immunoglobulin G (IgG) containing agent.
  • • Participant has any medical condition which in the opinion of the Investigator or Medical Monitor places the participant at an unacceptably high risk for toxicities.
  • • Participant is a lactating or pregnant female.
  • • Participants with known active Coronavirus Disease - 2019 (COVID-19) infection. Participant with signs/symptoms associated with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection during 14 days prior to Screening:
  • • 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.
  • • Participants may not receive nivolumab if they have:
  • • Active autoimmune disease with exceptions of vitiligo, type I diabetes mellitus, hypothyroidism and psoriasis.
  • • Used systemic corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration, with exception of inhaled, locally injected or topical steroids.
  • • Known immunosuppressive disease, for example human immunodeficiency virus infection or history of bone marrow transplant or chronic lymphocytic leukemia.
  • • Participants may not be enrolled into the osimertinib Combination Therapy Arm E if they have the following:
  • • History of hypersensitivity to active or inactive excipients of osimertinib.
  • • History of osimertinib dose reduction to below 80 mg once a day (QD).
  • • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib.
  • • Any of the following cardiac criteria: a) Mean resting corrected QT interval (QTc) > 470 ms; b) Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG, e.g., complete left bundle branch block, second- or third-degree heart block, PR interval > 250 ms; c) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, or any concomitant medication known to prolong the QT interval.

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
    • 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
    • University of California, Davis Comprehensive Cancer Center /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 DCAM /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, Missouri
    • Washington University-School of Medicine /ID# 143798 Saint Louis, Missouri, United States, 63110
  • United States, Montana
    • Billings Clinic /ID# 217650 Billings, Montana, United States, 59101-0733
  • United States, New Jersey
    • Summit Medical Group - Florham Park /ID# 217651 Florham Park, New Jersey, United States, 07932-1049
  • United States, New York
    • Northwell Health - Monter Cancer Center /ID# 218170 Lake Success, New York, United States, 11042
    • New York Presbyterian Hospital - Weill Cornell Medical Center /ID# 218445 New York, New York, United States, 10065
  • 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 January 14, 2021