Telisotuzumab Vedotin Clinical Trials

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: .

8
Total Trials
3
Recruiting
0
Completed
1,424
Total Enrollment
32
States
Telisotuzumab Vedotin Evidence & Publications

4 peer-reviewed publications + per-arm primary-outcome data from 0 pivotal trials.

See published evidence →
Telisotuzumab Vedotin Clinical Trials

Sortable list of all 8 Telisotuzumab Vedotin trials — recruiting status, pivotal acronyms, indication grouping, NCT links.

See all trials →
Telisotuzumab Vedotin History and Updates

Every FDA approval, label revision, recall, trial milestone, and pivotal publication for Telisotuzumab Vedotin — sourced from openFDA, ClinicalTrials.gov, and PubMed.

See full history →

Recent Telisotuzumab Vedotin updates

See full history →

What Is Telisotuzumab Vedotin?

Telisotuzumab Vedotin is a drug currently under investigation in clinical trials. It is administered as an Intravenous (IV) Infusion. While the specific mechanism of action is not detailed in the provided trial descriptions, it is being studied as a potential treatment for various cancers. Research is exploring its use both as a standalone therapy and in combination with other medications.

Clinical trials for Telisotuzumab Vedotin first began on March 28, 2014, with the latest trial initiated on January 7, 2026. A total of 8 trials have been conducted or are ongoing, with 3 trials currently recruiting participants. These studies have collectively enrolled 1,424 participants to date, investigating the drug's safety and effectiveness.

Uses and Conditions Under Study

Telisotuzumab Vedotin is primarily being investigated for its potential in treating various forms of cancer. The most extensively studied condition is Non-Small Cell Lung Cancer (NSCLC), which is a common type of lung cancer. This drug is being explored as a treatment option for NSCLC across 7 trials, aiming to address this challenging disease.

Additionally, Telisotuzumab Vedotin is being studied for its effects on Advanced Solid Tumors Cancer. This category includes cancers that have spread from their original site and are typically more difficult to treat. One trial is dedicated to understanding how Telisotuzumab Vedotin might benefit patients with these advanced cancers, exploring its potential to slow disease progression or improve patient outcomes.

Dosing

Telisotuzumab Vedotin is administered as an Intravenous (IV) Infusion. Clinical trials are investigating several different dosing strategies and combinations to determine the most effective and safest approach. These include various monotherapy regimens, such as Telisotuzumab Vedotin given in 21-day dosing cycles and 28-day dosing cycles.

Different investigational doses, referred to as Telisotuzumab Vedotin Dose A, Telisotuzumab Vedotin Dose B, and Telisotuzumab Vedotin Dose C, are being studied. The drug is also being explored in combination with other therapies. Investigational arms include Telisotuzumab Vedotin plus Osimertinib, Telisotuzumab Vedotin plus Erlotinib, and Telisotuzumab Vedotin plus Nivolumab. Some trials also compare Telisotuzumab Vedotin to Docetaxel or a Standard of Care regimen.

Side Effects

Information on the side effects of Telisotuzumab Vedotin from clinical trials was not available at the time of this review. Please consult with your healthcare provider for detailed information regarding potential side effects.

Clinical Trial Results

Telisotuzumab Vedotin for Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

In a study (NCT05513703) investigating Telisotuzumab Vedotin in adult participants with advanced or metastatic non-squamous non-small cell lung cancer, several key outcomes were assessed:

The study also evaluated changes in symptoms and quality of life using standardized questionnaires. On average, patients experienced an improvement in cough, with a mean change of -24.46 on the EORTC QLQ-LC13 scale, where negative scores indicate improvement. Changes in dyspnea (shortness of breath) and chest pain were minimal on average. Global health status and quality of life showed a slight average improvement of +1.96 on the EORTC QLQ-C30 scale, where positive scores indicate improvement.

Currently Recruiting Trials

Telisotuzumab vedotin is currently being investigated in several clinical trials for non-small cell lung cancer (NSCLC). These studies aim to understand its safety, effectiveness, and how it compares to existing treatments. Participating in a clinical trial can offer access to new treatments and contribute to medical knowledge. One ongoing Phase II trial, sponsored by Jonsson Comprehensive Cancer Center, is studying NCT07323641. This study is testing how well telisotuzumab vedotin works in combination with osimertinib for the treatment of non-small cell lung cancer that is progressive (growing or spreading) and currently considered incurable. The trial is designed to enroll approximately 60 participants who meet specific criteria for this advanced form of lung cancer. Another Phase II study, sponsored by AbbVie, is NCT06568939. This trial focuses on assessing the safety and pharmacokinetics (how the drug moves through the body) of telisotuzumab vedotin as a single treatment. It is open to adult participants with previously treated non-squamous non-small cell lung cancer. The study plans to enroll around 150 participants across different dosage groups to gather comprehensive data. The largest ongoing study is a Phase III trial, also sponsored by AbbVie, identified as NCT04928846. This study directly compares telisotuzumab vedotin to docetaxel, a standard chemotherapy, in adult participants with previously treated non-squamous non-small cell lung cancer. Researchers are evaluating disease activity and adverse events to determine if telisotuzumab vedotin offers a better treatment option. This pivotal trial aims to enroll approximately 698 participants.

Where to Participate

Clinical trials for telisotuzumab vedotin are actively recruiting across a wide geographic area, making participation accessible to many. Research sites are established in 86 locations across 64 cities and 32 states within the United States. Some of the cities with multiple participating sites include: To be eligible for these studies, participants must be between 18 and 18 years of age. All genders are welcome to participate, but these trials are not designed for healthy volunteers or children, as they focus on specific patient populations with non-small cell lung cancer.

Development Timeline

The journey of telisotuzumab vedotin began with its first clinical trial on March 28, 2014, marking the initial steps in its development. Since then, a total of 8 clinical trials have been initiated, involving a combined enrollment of 1,424 participants. The majority of these studies have been sponsored by AbbVie, with one trial sponsored by the Jonsson Comprehensive Cancer Center. Early in its development, telisotuzumab vedotin was explored for conditions such as IBS-C and hyperphosphatemia. However, the research focus soon expanded and shifted to oncology, particularly advanced solid tumors and various forms of lung cancer. The pipeline evolved to specifically target Lung Non-Small Cell Carcinoma and Non-Small Cell Lung Cancer (NSCLC), reflecting a strategic pivot in its therapeutic application. The drug's development has progressed through different phases, including one Phase I trial, four Phase II trials, and two Phase III trials, with one study phase not yet specified. This progression through phases indicates a systematic evaluation of its safety and efficacy. Research into telisotuzumab vedotin continues, with the latest trial projected to conclude on January 7, 2026, highlighting ongoing efforts to bring this potential treatment to patients.

Telisotuzumab Vedotin Development Timeline

Clinical trial activity from 2014 to 2026.

2026
NCT07323641PHASE2recruiting
Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer
60 enrolled
2025
NCT06568939PHASE2recruiting
A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
150 enrolled
2024
NCT06093503PHASE3withdrawn
Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein
0 enrolled
2022
NCT05513703PHASE2terminated
A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
9 enrolled
NCT04928846PHASE3recruiting
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
698 enrolled
2021
NCT04830202temporarily not available
Expanded Access to Telisotuzumab Vedotin
0 enrolled
2018
NCT03539536PHASE2active not recruiting
Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
270 enrolled
2014
NCT02099058PHASE1active not recruiting
A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors
237 enrolled

Conditions Under Study

ConditionNCT IDTitleStatusPhaseEnrollment
Non-Small Cell Lung CancerNCT06568939A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)recruitingPHASE2150
NCT06093503Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met ProteinwithdrawnPHASE30
NCT03539536Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Canceractive not recruitingPHASE2270
Non Small Cell Lung CancerNCT05513703A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)terminatedPHASE29
NCT04928846A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)recruitingPHASE3698
Advanced Solid Tumors CancerNCT02099058A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumorsactive not recruitingPHASE1237
Lung Non-Small Cell CarcinomaNCT07323641Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung CancerrecruitingPHASE260
Non-small Cell Lung CancerNCT06568939A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)recruitingPHASE2150
NCT06093503Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met ProteinwithdrawnPHASE30
NCT03539536Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Canceractive not recruitingPHASE2270
Non-Small Cell Lung Cancer (NSCLC)NCT04830202Expanded Access to Telisotuzumab Vedotintemporarily not availableN/A0

All Telisotuzumab Vedotin Clinical Trials (8)

NCT IDTitleStatusPhaseEnrollmentSponsor
NCT07323641Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung CancerrecruitingPHASE260Jonsson Comprehensive Cancer Center
NCT06568939A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)recruitingPHASE2150AbbVie
NCT06093503Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met ProteinwithdrawnPHASE30AbbVie
NCT05513703A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)terminatedPHASE29AbbVie
NCT04928846A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)recruitingPHASE3698AbbVie
NCT03539536Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Canceractive not recruitingPHASE2270AbbVie
NCT02099058A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumorsactive not recruitingPHASE1237AbbVie
NCT04830202Expanded Access to Telisotuzumab Vedotintemporarily not availableN/A0AbbVie

Sponsors

Where to Participate: All Telisotuzumab Vedotin Trial Sites in the U.S. (53 sites across 23 states)

Every actively recruiting Telisotuzumab Vedotintrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

StateFacilityCityTrialMap
AZIronwood Cancer and Research Center /ID# 276370Chandler85224NCT06568939Map
ARUniversity of Arkansas for Medical Sciences /ID# 272923Little Rock72205NCT06568939Map
CACity of Hope /ID# 243157Duarte91010NCT04928846Map
CACity Of Hope - Seacliff /ID# 263143Huntington Beach92648NCT04928846Map
CACity of Hope - Orange County Lennar Foundation Cancer Center /ID# 263144Irvine92618NCT04928846Map
CACity Of Hope - Antelope Valley /ID# 263138Lancaster93534NCT04928846Map
CAUCLA / Jonsson Comprehensive Cancer CenterLos Angeles90095NCT07323641Map
CAValkyrie Clinical Trials /ID# 271322Los Angeles90067NCT06568939Map
CAEisenhower Medical Center /ID# 233189Rancho Mirage92270-3221NCT04928846Map
CAPremiere Oncology Foundation /ID# 253954Santa Monica90404NCT04928846Map
CTYale New Haven Hospital /ID# 271584New Haven06510NCT06568939Map
FLCancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 270899Jacksonville32256NCT06568939Map
FLOcala Oncology Center /ID# 273697Ocala34474NCT06568939Map
FLMemorial Hospital West /ID# 270313Pembroke Pines33028NCT06568939Map
FLComprehensive Hematology Oncology /ID# 270422St. Petersburg33701-4732NCT06568939Map
FLFlorida Cancer Specialists - North /ID# 271995St. Petersburg33705NCT06568939Map
FLFlorida Cancer Specialists - East /ID# 271993West Palm Beach33401NCT06568939Map
GAUniversity Cancer & Blood Center /ID# 270969Athens30607NCT06568939Map
GANorthwest Georgia Oncology Centers /ID# 275374Marietta30060NCT06568939Map
GAMemorial University Medical Center /ID# 272467Savannah31404NCT06568939Map
HIKaiser Permanente Moanalua Medical Center /ID# 238363Honolulu96819-1469NCT04928846Map
HIKaiser Permanente Moanalua Medical Center /ID# 272916Honolulu96819NCT06568939Map
ILUniversity of Illinois Hospital and Health Sciences System /ID# 275345Chicago60607NCT06568939Map
ILIllinois Cancer Specialists /ID# 274678Niles60714NCT06568939Map
ILSpringfield Clinic - First /ID# 272576Springfield62702NCT06568939Map
MSHattiesburg Clinic /ID# 248033Hattiesburg39401NCT04928846Map
MOSt. Lukes Hosp. of Kansas City /ID# 259940Kansas City64111NCT04928846Map
MOHulston Cancer Center /ID# 232226Springfield65807-5287NCT04928846Map
NENHO - Nebraska Hematology-Oncology /ID# 272970Lincoln68506NCT06568939Map
NENebraska Cancer Specialists - Omaha - Wright Street /ID# 271527Omaha68130NCT06568939Map
NVRenown Medical Group - Oncology/Hematology /ID# 247942Reno89502-1464NCT04928846Map
NVRenown Regional Medical Center /ID# 273535Reno89502NCT06568939Map
NJAstera Cancer Care /ID# 272359East Brunswick08816-4096NCT06568939Map
NJRegional Cancer Care Associates /ID# 270783Teaneck07666NCT06568939Map
NYMontefiore Medical Center - Einstein Campus /ID# 277169The Bronx10461NCT06568939Map
NYClinical Research Alliance - Westbury /ID# 270455Westbury11590NCT06568939Map
NCAdventHealth Hendersonville /ID# 265349Hendersonville28792NCT04928846Map
NCFirstHealth of the Carolinas- Speciality Center /ID# 272924Pinehurst28374NCT06568939Map
OHMercy Health - Perrysburg Cancer Center /ID# 270536Perrysburg43551NCT06568939Map
OHGenesis Healthcare System /ID# 273361Zanesville43701NCT06568939Map
PAGuthrie Robert Packer Hospital /ID# 270316Sayre18840NCT06568939Map
PACancer Care Associates Of York /ID# 270971York17403NCT06568939Map
SCMedical University of South Carolina /ID# 251383Charleston29425NCT04928846Map
SCMedical University of South Carolina /ID# 273272Charleston29425NCT06568939Map
SCSaint Francis Cancer Center - Greenville /ID# 276368Greenville29607NCT06568939Map
TNSCRI Oncology Partners /ID# 270162Nashville37203NCT06568939Map
TXTexas Oncology - Dallas - Worth Street /ID# 278947Dallas75246NCT06568939Map
TXTexas Oncology - Northeast Texas /ID# 272000Tyler75702NCT06568939Map
UTCommunity Cancer Trials Of Utah /ID# 276598Ogden84405NCT06568939Map
VAVirginia Cancer Specialists - Fairfax /ID# 272004Fairfax22031NCT06568939Map
WAValley Medical Center /ID# 253950Renton98055-5738NCT04928846Map
WAMedical Oncology Associates - Spokane /ID# 277172Spokane99208NCT06568939Map
WANorthwest Medical Specialties Tacoma /ID# 270534Tacoma98405NCT06568939Map

Browse Telisotuzumab Vedotin Trials by State

telisotuzumab vedotinnon-small cell lung cancernon small cell lung canceradvanced solid tumors cancerlung non-small cell carcinomanon-small cell lung cancerclinical trials
Data sourced from the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI). Report generated .