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Clinical Trials in China / NCT02099058
Active, not recruiting Phase 1

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

NCT02099058 · tracked via the Priya Life Science China tracker
Sponsor
AbbVie
Phase
Phase 1
Started
2014-01-15
Last updated
2025-08-14

Condition(s) studied

Advanced Solid Tumors Cancer

Investigational drug(s) / intervention(s)

OsimertinibNivolumabTelisotuzumab vedotinTelisotuzumab vedotinErlotinib

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy 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. 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 radiation therapy to the lung \< 6 months prior to the first dose of ABBV-399. * 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 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. * 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.

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
Scottsdale Healthcare /ID# 123761 Scottsdale Arizona
City of Hope /ID# 153759 Duarte California
University of California, Los Angeles /ID# 148295 Los Angeles California
UC Irvine /ID# 165107 Orange California
University of California, Davis Comprehensive Cancer Center /ID# 129805 Sacramento California
Univ of Colorado Cancer Center /ID# 123759 Aurora Colorado
The University of Chicago Medical Center /ID# 136995 Chicago Illinois
Ingalls Memorial Hosp /ID# 165876 Harvey Illinois
Massachusetts General Hospital /ID# 129804 Boston Massachusetts
Dana-Farber Cancer Institute /ID# 168782 Boston Massachusetts
Duplicate_Henry Ford Health System /ID# 149857 Detroit Michigan
Herbert Herman Cancer Center /ID# 149858 Lansing Michigan
Washington University-School of Medicine /ID# 143798 St Louis Missouri
Summit Medical Group-Florham Park /ID# 217651 Florham Park New Jersey
Northwell Health - Monter Cancer Center /ID# 218170 Lake Success New York
Montefiore Medical Park at Eastchester /ID# 218445 The Bronx New York
Duke Cancer Center /ID# 123763 Durham North Carolina
Tennessee Oncology, PLLC /ID# 129802 Nashville Tennessee
Mary Crowley Cancer Research /ID# 123760 Dallas Texas
University of Texas MD Anderson Cancer Center /ID# 154648 Houston Texas
Virginia Cancer Specialists - Fairfax /ID# 165708 Fairfax Virginia
Universitair Ziekenhuis Antwerpen /ID# 170118 Edegem Antwerpen
Duplicate_Tampere University Hospital /ID# 165065 Tampere Pirkanmaa
AP-HM - Hopital de la Timone /ID# 151570 Marseille Bouches-du-Rhone
Institut Gustave Roussy /ID# 132747 Villejuif Val-de-Marne
Duplicate_Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS /ID# 164077 Meldola Emilia-Romagna
National Cancer Center Hospital East /ID# 217570 Kashiwa-shi Chiba
National Cancer Center Hospital /ID# 217571 Chuo-ku Tokyo
Radboud Universitair Medisch Centrum /ID# 246908 Nijmegen Gelderland
Duplicate_The Catholic University of Korea, ST. Vincent's Hospital /ID# 233378 Suwon Gyeonggido
Asan Medical Center /ID# 217334 Seoul Seoul Teugbyeolsi
Yonsei University Health System Severance Hospital /ID# 217333 Seoul South Korea
China Medical University Hospital /ID# 217494 Taichung Taichung
National Cheng Kung University Hospital /ID# 167175 Tainan Tainan
National Taiwan University Hospital /ID# 167173 Taipei City Taipei
Taipei Veterans General Hosp /ID# 217392 Taipei Taipei

On this site

📄 Tagrisso (osimertinib) drug profile → 📄 Opdivo (nivolumab) drug profile → 📄 Tarceva (erlotinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02099058 on ClinicalTrials.gov ↗ ← All trials in China