A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors
NCT ID: NCT02099058
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
237 participants
INTERVENTIONAL
2014-01-15
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
Telisotuzumab vedotin
It is administered by infusion in 21-day dosing cycles.
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.
Telisotuzumab vedotin
It is administered by infusion in 28-day dosing cycles.
Monotherapy Expansion Cohort
Telisotuzumab vedotin will be administered every 14 days on a 28-day dosing cycle.
Telisotuzumab vedotin
It is administered by infusion in 28-day dosing cycles.
Arm A (Telisotuzumab vedotin plus Erlotinib)
Telisotuzumab vedotin to be evaluated with Erlotinib.
Telisotuzumab vedotin
It is administered by infusion in 21-day dosing cycles.
Erlotinib
It is administered orally everyday.
Arm D (Telisotuzumab vedotin plus Nivolumab)
Telisotuzumab vedotin to be evaluated with Nivolumab.
Nivolumab
It is an intravenous infusion administered every 14 days.
Telisotuzumab vedotin
It is administered by infusion in 28-day dosing cycles.
Arm E (Telisotuzumab vedotin plus Osimertinib)
Telisotuzumab vedotin to be evaluated with Osimertinib.
Osimertinib
It is administered orally everyday.
Telisotuzumab vedotin
It is administered by infusion in 28-day dosing cycles.
Interventions
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Osimertinib
It is administered orally everyday.
Nivolumab
It is an intravenous infusion administered every 14 days.
Telisotuzumab vedotin
It is administered by infusion in 21-day dosing cycles.
Telisotuzumab vedotin
It is administered by infusion in 28-day dosing cycles.
Erlotinib
It is administered orally everyday.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. For Monotherapy Expansion Cohort, participant must have ECOG Performance Status of 0 or 1.
* 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. Consecutive EGFR TKIs will count as 1 regimen
* Participant must have available post-progression tumor tissue for central c-Met immunohistochemistry (IHC) testing.
* Participant has adequate bone marrow function.
* Participants in the Monotherapy Expansion Cohort must satisfy following criteria.
* Participant must have locally advanced or metastatic, non-squamous, EGFR wild type, c-Met+ NSCLC. Participants must not have adenosquamous histology.
* Participant must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting.
* Participant must have progressed on systemic cytotoxic chemotherapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible for an immune checkpoint inhibitor), and prior anti-cancer therapies targeting driver gene alterations (if applicable).
* Participant should not have received prior c-Met-targeted antibody-based therapies.
Exclusion Criteria
* Participant has received anticancer therapy including chemotherapy, 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 2-4 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.
* Participant has evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or interstitial lung disease (ILD) within 3 months of the planned first dose of the study drug.
* 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.
* Participant with known active COVID-19 infection, subjects 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 must be screen failed and may only rescreen after they have recovered from COVID-19 and they are no longer considered contagious, per investigator assessment.
* 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.
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Scottsdale Healthcare /ID# 123761
Scottsdale, Arizona, United States
City of Hope /ID# 153759
Duarte, California, United States
University of California, Los Angeles /ID# 148295
Los Angeles, California, United States
UC Irvine /ID# 165107
Orange, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 129805
Sacramento, California, United States
Univ of Colorado Cancer Center /ID# 123759
Aurora, Colorado, United States
The University of Chicago Medical Center /ID# 136995
Chicago, Illinois, United States
Ingalls Memorial Hosp /ID# 165876
Harvey, Illinois, United States
Massachusetts General Hospital /ID# 129804
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 168782
Boston, Massachusetts, United States
Duplicate_Henry Ford Health System /ID# 149857
Detroit, Michigan, United States
Herbert Herman Cancer Center /ID# 149858
Lansing, Michigan, United States
Washington University-School of Medicine /ID# 143798
St Louis, Missouri, United States
Summit Medical Group-Florham Park /ID# 217651
Florham Park, New Jersey, United States
Northwell Health - Monter Cancer Center /ID# 218170
Lake Success, New York, United States
Montefiore Medical Park at Eastchester /ID# 218445
The Bronx, New York, United States
Duke Cancer Center /ID# 123763
Durham, North Carolina, United States
Tennessee Oncology, PLLC /ID# 129802
Nashville, Tennessee, United States
Mary Crowley Cancer Research /ID# 123760
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center /ID# 154648
Houston, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 165708
Fairfax, Virginia, United States
Universitair Ziekenhuis Antwerpen /ID# 170118
Edegem, Antwerpen, Belgium
Duplicate_Tampere University Hospital /ID# 165065
Tampere, Pirkanmaa, Finland
AP-HM - Hopital de la Timone /ID# 151570
Marseille, Bouches-du-Rhone, France
Institut Gustave Roussy /ID# 132747
Villejuif, Val-de-Marne, France
Duplicate_Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS /ID# 164077
Meldola, Emilia-Romagna, Italy
National Cancer Center Hospital East /ID# 217570
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital /ID# 217571
Chuo-ku, Tokyo, Japan
Radboud Universitair Medisch Centrum /ID# 246908
Nijmegen, Gelderland, Netherlands
Duplicate_The Catholic University of Korea, ST. Vincent's Hospital /ID# 233378
Suwon, Gyeonggido, South Korea
Asan Medical Center /ID# 217334
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 217333
Seoul, , South Korea
China Medical University Hospital /ID# 217494
Taichung, Taichung, Taiwan
National Cheng Kung University Hospital /ID# 167175
Tainan City, Tainan, Taiwan
National Taiwan University Hospital /ID# 167173
Taipei City, Taipei, Taiwan
Taipei Veterans General Hosp /ID# 217392
Taipei, Taipei, Taiwan
Countries
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References
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Camidge DR, Barlesi F, Goldman JW, Morgensztern D, Heist R, Vokes E, Spira A, Angevin E, Su WC, Hong DS, Strickler JH, Motwani M, Dunbar M, Parikh A, Noon E, Blot V, Wu J, Kelly K. Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein-Expressing Non-Small-Cell Lung Cancer. J Clin Oncol. 2023 Feb 10;41(5):1105-1115. doi: 10.1200/JCO.22.00739. Epub 2022 Oct 26.
Camidge DR, Morgensztern D, Heist RS, Barve M, Vokes E, Goldman JW, Hong DS, Bauer TM, Strickler JH, Angevin E, Motwani M, Parikh A, Sun Z, Bach BA, Wu J, Komarnitsky PB, Kelly K. Phase I Study of 2- or 3-Week Dosing of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, Monotherapy in Patients with Advanced Non-Small Cell Lung Carcinoma. Clin Cancer Res. 2021 Nov 1;27(21):5781-5792. doi: 10.1158/1078-0432.CCR-21-0765. Epub 2021 Aug 23.
Strickler JH, Weekes CD, Nemunaitis J, Ramanathan RK, Heist RS, Morgensztern D, Angevin E, Bauer TM, Yue H, Motwani M, Parikh A, Reilly EB, Afar D, Naumovski L, Kelly K. First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, in Patients With Advanced Solid Tumors. J Clin Oncol. 2018 Nov 20;36(33):3298-3306. doi: 10.1200/JCO.2018.78.7697. Epub 2018 Oct 4.
Other Identifiers
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2014-003154-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M14-237
Identifier Type: -
Identifier Source: org_study_id
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