AzTrials
AzTrials

Advanced Solid Tumors CancerPhase 1NCT02099058

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

A Phase 1 study testing Osimertinib, Nivolumab and Telisotuzumab vedotin in people with Advanced Solid Tumors Cancer, run by AbbVie at 36 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors Cancer
What is being tested?
Osimertinib, Nivolumab and Telisotuzumab vedotin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
237 participants
Where
36 sitesin 9 countries
Study dates
15 Jan 2014to Aug 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.

Trial locations and contacts

36 sites in 9 countries.

36 sites in 9 countries

United States21 sites

  • Univ of Colorado Cancer Center /ID# 123759

    Aurora, Colorado, 80045

  • Massachusetts General Hospital /ID# 129804

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute /ID# 168782

    Boston, Massachusetts, 02215

  • The University of Chicago Medical Center /ID# 136995

    Chicago, Illinois, 60637-1443

  • Mary Crowley Cancer Research /ID# 123760

    Dallas, Texas, 75230

  • Duplicate_Henry Ford Health System /ID# 149857

    Detroit, Michigan, 48202

  • City of Hope /ID# 153759

    Duarte, California, 91010

  • Duke Cancer Center /ID# 123763

    Durham, North Carolina, 27710-3000

  • Virginia Cancer Specialists - Fairfax /ID# 165708

    Fairfax, Virginia, 22031

  • Summit Medical Group-Florham Park /ID# 217651

    Florham Park, New Jersey, 07932-1049

  • Ingalls Memorial Hosp /ID# 165876

    Harvey, Illinois, 60426

  • University of Texas MD Anderson Cancer Center /ID# 154648

    Houston, Texas, 77030

  • Northwell Health - Monter Cancer Center /ID# 218170

    Lake Success, New York, 11042

  • Herbert Herman Cancer Center /ID# 149858

    Lansing, Michigan, 48912

  • University of California, Los Angeles /ID# 148295

    Los Angeles, California, 90095

  • Tennessee Oncology, PLLC /ID# 129802

    Nashville, Tennessee, 37203

  • UC Irvine /ID# 165107

    Orange, California, 92868

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

    Sacramento, California, 95817

  • Scottsdale Healthcare /ID# 123761

    Scottsdale, Arizona, 85258-4566

  • Washington University-School of Medicine /ID# 143798

    St Louis, Missouri, 63110

  • Montefiore Medical Park at Eastchester /ID# 218445

    The Bronx, New York, 10461

Other trials in United States

Taiwan4 sites

  • China Medical University Hospital /ID# 217494

    Taichung, Taichung, 40447

  • National Cheng Kung University Hospital /ID# 167175

    Tainan, Tainan, 704

  • Taipei Veterans General Hosp /ID# 217392

    Taipei, Taipei, 11217

  • National Taiwan University Hospital /ID# 167173

    Taipei City, Taipei, 100

Other trials in Taiwan

South Korea3 sites

  • Asan Medical Center /ID# 217334

    Seoul, Seoul Teugbyeolsi, 05505

  • Yonsei University Health System Severance Hospital /ID# 217333

    Seoul, 03722

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

    Suwon, Gyeonggido, 16247

Other trials in South Korea

France2 sites

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

    Marseille, Bouches-du-Rhone, 13385

  • Institut Gustave Roussy /ID# 132747

    Villejuif, Val-de-Marne, 94805

Other trials in France

Japan2 sites

  • National Cancer Center Hospital /ID# 217571

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 217570

    Kashiwa-shi, Chiba, 277-8577

Other trials in Japan

Belgium1 site

  • Universitair Ziekenhuis Antwerpen /ID# 170118

    Edegem, Antwerpen, 2650

Other trials in Belgium

Finland1 site

  • Duplicate_Tampere University Hospital /ID# 165065

    Tampere, Pirkanmaa, 33520

Other trials in Finland

Italy1 site

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

    Meldola, Emilia-Romagna, 47014

Other trials in Italy

Netherlands1 site

  • Radboud Universitair Medisch Centrum /ID# 246908

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

About this study

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

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.

Being tested
Osimertinib, Nivolumab, Telisotuzumab vedotin, Erlotinib
Keywords
Cancer, Advanced Solid Tumor, Neoplasm
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OsimertinibDrug

    It is administered orally everyday.

  • NivolumabDrug

    It is an intravenous infusion administered every 14 days.

  • Telisotuzumab vedotinDrug

    Also called ABBV-399

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

  • Telisotuzumab vedotinDrug

    Also called ABBV-399

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

  • ErlotinibDrug

    It is administered orally everyday.

Study groups in NCT02099058
Study groupRoleWhat they receive
Monotherapy Telisotuzumab vedotin (21-day dosing cycles)ExperimentalTelisotuzumab 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.
Receives: Drug: Telisotuzumab vedotin
Monotherapy Telisotuzumab vedotin(28-day dosing cycles)ExperimentalTelisotuzumab 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.
Receives: Drug: Telisotuzumab vedotin
Monotherapy Expansion CohortExperimentalTelisotuzumab vedotin will be administered every 14 days on a 28-day dosing cycle.
Receives: Drug: Telisotuzumab vedotin
Arm A (Telisotuzumab vedotin plus Erlotinib)ExperimentalTelisotuzumab vedotin to be evaluated with Erlotinib.
Receives: Drug: Telisotuzumab vedotin; Drug: Erlotinib
Arm D (Telisotuzumab vedotin plus Nivolumab)ExperimentalTelisotuzumab vedotin to be evaluated with Nivolumab.
Receives: Drug: Nivolumab; Drug: Telisotuzumab vedotin
Arm E (Telisotuzumab vedotin plus Osimertinib)ExperimentalTelisotuzumab vedotin to be evaluated with Osimertinib.
Receives: Drug: Osimertinib; Drug: Telisotuzumab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measured: Up to 24 Months

  2. Recommended Phase 2 Dose (RPTD) of ABBV-399 when Administered as Monotherapy and in Combination with Osimertinib, Erlotinib or Nivolumab

    The RPTD of ABBV-399 when administered as monotherapy and in combination with osimertinib, erlotinib or nivolumab will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data.

    Measured: Up to 24 Months

  3. Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)

    AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.

    Measured: Up to 24 months

  4. Maximum observed plasma concentration (Cmax)

    Maximum observed plasma concentration (Cmax).

    Measured: Up to 24 months

  5. Time to Cmax (Tmax)

    Time to Cmax (Tmax).

    Measured: Up to 24 months

  6. Terminal elimination half life

    Terminal elimination half life.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2014 (estimated)
  2. Study start15 Jan 2014
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
237 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02099058
Sponsor's protocol ID
M14-237
Other IDs
2014-003154-14, 2014
Status last verified
Aug 2025
First submitted
26 Mar 2014
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Horinouchi H, Cho BC, Camidge DR, Goto K, Tomasini P, Li Y, Vasilopoulos A, Brunsdon P, Hoffman D, Shi W, Bolotin E, Blot V, Goldman J. Results from a phase Ib study of telisotuzumab vedotin in combination with osimertinib in patients with c-Met protein-overexpressing, EGFR-mutated locally advanced/metastatic non-small-cell lung cancer (NSCLC) after progression on prior osimertinib. Ann Oncol. 2025 May;36(5):583-591. doi: 10.1016/j.annonc.2025.01.001. Epub 2025 Jan 11.

    PubMed 39805351

  • 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.

    PubMed 36288547

  • 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.

    PubMed 34426443

  • 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.

    PubMed 30285518

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Osimertinib, Nivolumab and Telisotuzumab vedotin in people with Advanced Solid Tumors Cancer, run by AbbVie at 36 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Taiwan, South Korea, France, Japan and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (time frame: Up to 24 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02099058, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in