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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-15

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Telisotuzumab vedotin

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Telisotuzumab vedotin

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Telisotuzumab vedotin

Intervention Type DRUG

It is administered by infusion in 28-day dosing cycles.

Arm A (Telisotuzumab vedotin plus Erlotinib)

Telisotuzumab vedotin to be evaluated with Erlotinib.

Group Type EXPERIMENTAL

Telisotuzumab vedotin

Intervention Type DRUG

It is administered by infusion in 21-day dosing cycles.

Erlotinib

Intervention Type DRUG

It is administered orally everyday.

Arm D (Telisotuzumab vedotin plus Nivolumab)

Telisotuzumab vedotin to be evaluated with Nivolumab.

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

It is an intravenous infusion administered every 14 days.

Telisotuzumab vedotin

Intervention Type DRUG

It is administered by infusion in 28-day dosing cycles.

Arm E (Telisotuzumab vedotin plus Osimertinib)

Telisotuzumab vedotin to be evaluated with Osimertinib.

Group Type EXPERIMENTAL

Osimertinib

Intervention Type DRUG

It is administered orally everyday.

Telisotuzumab vedotin

Intervention Type DRUG

It is administered by infusion in 28-day dosing cycles.

Interventions

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Osimertinib

It is administered orally everyday.

Intervention Type DRUG

Nivolumab

It is an intravenous infusion administered every 14 days.

Intervention Type DRUG

Telisotuzumab vedotin

It is administered by infusion in 21-day dosing cycles.

Intervention Type DRUG

Telisotuzumab vedotin

It is administered by infusion in 28-day dosing cycles.

Intervention Type DRUG

Erlotinib

It is administered orally everyday.

Intervention Type DRUG

Other Intervention Names

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ABBV-399 ABBV-399

Eligibility Criteria

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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 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

City of Hope /ID# 153759

Duarte, California, United States

Site Status

University of California, Los Angeles /ID# 148295

Los Angeles, California, United States

Site Status

UC Irvine /ID# 165107

Orange, California, United States

Site Status

University of California, Davis Comprehensive Cancer Center /ID# 129805

Sacramento, California, United States

Site Status

Univ of Colorado Cancer Center /ID# 123759

Aurora, Colorado, United States

Site Status

The University of Chicago Medical Center /ID# 136995

Chicago, Illinois, United States

Site Status

Ingalls Memorial Hosp /ID# 165876

Harvey, Illinois, United States

Site Status

Massachusetts General Hospital /ID# 129804

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute /ID# 168782

Boston, Massachusetts, United States

Site Status

Duplicate_Henry Ford Health System /ID# 149857

Detroit, Michigan, United States

Site Status

Herbert Herman Cancer Center /ID# 149858

Lansing, Michigan, United States

Site Status

Washington University-School of Medicine /ID# 143798

St Louis, Missouri, United States

Site Status

Summit Medical Group-Florham Park /ID# 217651

Florham Park, New Jersey, United States

Site Status

Northwell Health - Monter Cancer Center /ID# 218170

Lake Success, New York, United States

Site Status

Montefiore Medical Park at Eastchester /ID# 218445

The Bronx, New York, United States

Site Status

Duke Cancer Center /ID# 123763

Durham, North Carolina, United States

Site Status

Tennessee Oncology, PLLC /ID# 129802

Nashville, Tennessee, United States

Site Status

Mary Crowley Cancer Research /ID# 123760

Dallas, Texas, United States

Site Status

University of Texas MD Anderson Cancer Center /ID# 154648

Houston, Texas, United States

Site Status

Virginia Cancer Specialists - Fairfax /ID# 165708

Fairfax, Virginia, United States

Site Status

Universitair Ziekenhuis Antwerpen /ID# 170118

Edegem, Antwerpen, Belgium

Site Status

Duplicate_Tampere University Hospital /ID# 165065

Tampere, Pirkanmaa, Finland

Site Status

AP-HM - Hopital de la Timone /ID# 151570

Marseille, Bouches-du-Rhone, France

Site Status

Institut Gustave Roussy /ID# 132747

Villejuif, Val-de-Marne, France

Site Status

Duplicate_Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS /ID# 164077

Meldola, Emilia-Romagna, Italy

Site Status

National Cancer Center Hospital East /ID# 217570

Kashiwa-shi, Chiba, Japan

Site Status

National Cancer Center Hospital /ID# 217571

Chuo-ku, Tokyo, Japan

Site Status

Radboud Universitair Medisch Centrum /ID# 246908

Nijmegen, Gelderland, Netherlands

Site Status

Duplicate_The Catholic University of Korea, ST. Vincent's Hospital /ID# 233378

Suwon, Gyeonggido, South Korea

Site Status

Asan Medical Center /ID# 217334

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Yonsei University Health System Severance Hospital /ID# 217333

Seoul, , South Korea

Site Status

China Medical University Hospital /ID# 217494

Taichung, Taichung, Taiwan

Site Status

National Cheng Kung University Hospital /ID# 167175

Tainan City, Tainan, Taiwan

Site Status

National Taiwan University Hospital /ID# 167173

Taipei City, Taipei, Taiwan

Site Status

Taipei Veterans General Hosp /ID# 217392

Taipei, Taipei, Taiwan

Site Status

Countries

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United States Belgium Finland France Italy Japan Netherlands South Korea Taiwan

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.

Reference Type DERIVED
PMID: 36288547 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34426443 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30285518 (View on PubMed)

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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