Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03539536
• Other study ID #: M14-239
• Secondary ID: 2023-507902-15-0
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 10, 2018
• Est. completion date: October 6, 2025

Study information

• Verified date: January 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 270
• Est. completion date: October 6, 2025
• Est. primary completion date: October 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have locally advanced or metastatic non-small cell lung cancer (NSCLC).

• Have c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory. Participant must submit archival or fresh tumor material for assessment of c-Met levels during the prescreening period. Tumor material from the primary tumor site and/or metastatic sites are allowed. If archival tissue is negative for c-Met overexpression, subject can submit fresh biopsy material for reassessment of c-Met expression.

• Histologically documented non-squamous epidermal growth factor receptor (EGFR) wild type NSCLC (site documented EGFR status). Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met. As of Protocol Version 11, Stage 1 is complete and Stage 2 is enrolling participants with non-squamous EGFR wild type NSCLC only.

• 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.

• Multiple lines of tyrosine kinase inhibitors (TKIs) targeting the same tyrosine kinase (TK) count as 1 line of therapy for the purposes of this eligibility criterion.

• Progressed on systemic cytotoxic therapy (or are ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint inhibitor (as monotherapy or in combination with systemic cytotoxic chemotherapy, or ineligible), and prior anticancer therapies targeting driver gene alterations (if applicable).

• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

• Treatment with any therapies within the noted time intervals is excluded prior to the first dose of telisotuzumab vedotin as noted in the protocol.

• Metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy) is provided within the protocol.

Exclusion Criteria:

• Have received radiation therapy to the lungs < 6 months prior to the first dose of telisotuzumab vedotin.

• Have received any live vaccine within 30 days of the first dose of investigational product.

• Has adenosquamous histology.

• Have a history of other malignancies except those noted within the protocol.

• Have a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids.

• Have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD within 3 months of the planned first dose of the study drug (Except for Sites in Ireland). For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.

• For Sites in Ireland Only: Must not have any evidence of pulmonary fibrosis on screening imaging assessment or any history of pneumonitis or ILD. For imaging findings deemed clinically insignificant by the treating physician, subject may be eligible after discussion with and approval from the AbbVie medical monitor.

• Have a clinically significant condition(s) as noted in the protocol.

• Have unresolved clinically significant adverse events of Grade >= 2 from prior anticancer therapy, except for alopecia or anemia.

• Have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.

• For Sites in France and Czech Republic Only: Have the following:

• Known human immunodeficiency virus (HIV) infection. Note: HIV testing is not required for eligibility for this protocol unless mandated by local regulatory authority or ethics committee/institutional review board.

• Active hepatitis B virus (HBV) infection, defined by hepatitis B surface antigen (HBsAg) positivity or HBV DNA >= 500 IU/mL. In participants with known HBV infection, the presence of active infection must be tested locally. If HBV status is unknown, it must be tested locally at screening.

• Active hepatitis C virus (HCV) infection, defined by HCV ribonucleic acid (RNA) positivity. Participants cured of HCV infection may be included in the study. In participants with known HCV infection, the presence of active infection must be tested locally. If HCV status is unknown, it must be tested locally at screening.

• Uncontrolled autoimmune disease.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Telisotuzumab vedotin
Intravenous (IV) infusion

Locations

Country	Name	City	State
Australia	The Kinghorn Cancer Centre /ID# 207666	Darlinghurst	New South Wales
Australia	Newcastle Private Hospital /ID# 206600	Lambton Heights	New South Wales
Australia	Mater Misericordiae Limited /ID# 229639	South Brisbane	Queensland
Australia	St John Of God Subiaco Hospital /ID# 226943	Subiaco	Western Australia
Australia	The Tweed Hospital /ID# 206601	Tweed Heads	New South Wales
Belgium	Institut Jules Bordet /ID# 238614	Anderlecht
Belgium	Universitair Ziekenhuis Antwerpen /ID# 217430	Edegem	Antwerpen
Belgium	AZ Maria Middelares /ID# 233474	Gent
Belgium	Jessa Ziekenhuis /ID# 234047	Hasselt
Belgium	AZ Groeninge /ID# 217431	Kortrijk
Belgium	Hospital La Louviere Site Jolimont - Helora /ID# 230586	La Louvière	Hainaut
Belgium	CHU de Liege /ID# 230589	Liege
Belgium	CHU UCL Namur - Sainte Elisabeth /ID# 234048	Namur
Belgium	Vitaz /Id# 239966	Sint-Niklaas	Oost-Vlaanderen
Bulgaria	MHAT Dobrich /ID# 230074	Dobrich
Bulgaria	UMHAT Dr Georgi Stranski EAD /ID# 232024	Pleven
Bulgaria	Acibadem City Clinic Tokuda University Hospital EAD /ID# 232010	Sofia
Bulgaria	Medical Center Nadezhda /ID# 230473	Sofia
Canada	Cross Cancer Institute /ID# 204540	Edmonton	Alberta
Canada	CISSS de la Monteregie /ID# 211356	Greenfield Park	Quebec
Canada	Ottawa Hospital Research Institute /ID# 205579	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre /ID# 204423	Toronto	Ontario
China	Affiliated Hospital of Hebei University /ID# 227262	Baoding	Hebei
China	Beijing Cancer Hospital /ID# 210133	Beijing	Beijing
China	Jilin Cancer Hospital /ID# 210563	Changchun	Jilin
China	The First People's Hospital of Changzhou /ID# 210787	Changzhou	Jiangsu
China	West China Hospital, Sichuan University /ID# 210022	Chengdu	Sichuan
China	Fujian Provincial Cancer Hospital /ID# 210808	Fuzhou	Fujian
China	The First Affiliated Hospital of Guangzhou Medical University /ID# 232261	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 211154	Hangzhou	Zhejiang
China	Zhejiang Cancer hospital /ID# 210085	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital /Id# 231573	Harbin	Heilongjiang
China	Anhui Chest Hospital /ID# 239048	Hefei	Anhui
China	Anhui Provincial Cancer Hospital /ID# 239058	Hefei	Anhui
China	Anhui Provincial Hospital /ID# 212096	Hefei	Anhui
China	Shandong Cancer Hospital /ID# 231577	Jinan	Shandong
China	Guangxi Medical University Cancer Center /ID# 231560	Nanning	Guangxi
China	Fudan University Shanghai Cancer Center /Id# 210084	Shanghai	Shanghai
China	Shanghai Chest Hospital /ID# 210930	Shanghai	Shanghai
China	The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 227244	Urumqi	Xinjiang
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211119	Wuhan	Hubei
China	Henan Cancer Hospital /ID# 210961	Zhengzhou	Henan
Czechia	Multiscan s.r.o. /ID# 241926	Praha
Czechia	Vseobecna fakultni nemocnice v Praze /ID# 229797	Praha
France	Institut Bergonie /ID# 216207	Bordeaux	Gironde
France	HCL - Hopital Louis Pradel /ID# 216209	Bron	Rhone
France	Centre Hosp Intercommunal de Creteil /ID# 227108	Creteil	Val-de-Marne
France	CHU Lille - Hôpital Albert Calmette /ID# 205105	Lille	Hauts-de-France
France	Centre Leon Berard /ID# 205107	Lyon CEDEX 08	Rhone
France	APHM - Hopital Nord /ID# 209854	Marseille	Bouches-du-Rhone
France	Institut Curie /ID# 207046	Paris CEDEX 05	Paris
France	CHU Strasbourg - Hopital Civil /ID# 208080	Strasbourg cedex
France	CHI Toulon-La Seyne sur Mer /ID# 230545	Toulon
France	Institut Gustave Roussy /ID# 205149	Villejuif Cedex	Val-de-Marne
Germany	Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 232052	Augsburg	Bayern
Germany	Vivantes Klinikum Neukolln /ID# 205928	Berlin
Germany	Asklepios Fachkliniken Muenchen-Gauting /ID# 207789	Gauting
Germany	Universitaetsklinikum Giessen /ID# 231856	Gießen	Hessen
Germany	Krankenhaus Martha-Maria Halle-Doelau /ID# 205442	Halle (Saale)	Sachsen-Anhalt
Germany	Evangelisches Krankenhaus Hamm /ID# 208043	Hamm
Germany	Klinikum Kassel /ID# 205443	Kassel
Germany	Universitatsklinikum Mannheim /ID# 228798	Mannheim	Baden-Wuerttemberg
Germany	Pius-Hospital Oldenburg /ID# 211615	Oldenburg
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 205530	Heraklion	Kriti
Greece	Metropolitan Hospital /ID# 205529	Piraeus	Attiki
Greece	Bioclinic Thessaloniki /ID# 227261	Thessaloniki
Greece	Euromedica General Clinic /ID# 227264	Thessaloniki
Hungary	Semmelweis Egyetem /ID# 204434	Budapest
Hungary	CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878	Encs	Borsod-Abauj-Zemplen
Hungary	Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950	Farkasgyepu
Hungary	Matrai Gyogyintezet /ID# 204432	Matrahaza
Hungary	Torokbalinti Tudogyogyintezet /ID# 204883	Torokbalint	Pest
Ireland	Mater Misericordiae Univ Hospital /ID# 231466	Dublin 7	Dublin
Ireland	St James Hospital /ID# 205104	Dublin 8	Dublin
Ireland	St Vincent's University Hospital /ID# 205102	Elm Park	Dublin
Ireland	Cork University Hospital /ID# 205103	Wilton	Cork
Israel	Soroka University Medical Center /ID# 204898	Be'er Sheva	HaDarom
Israel	Rabin Medical Center /ID# 215322	Haifa	H_efa
Israel	Rambam Health Care Campus /ID# 204866	Haifa	H_efa
Israel	Meir Medical Center /ID# 204255	Kfar Saba	HaMerkaz
Israel	The Chaim Sheba Medical Center /ID# 204254	Ramat Gan	Tel-Aviv
Italy	L'Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Mos /ID# 204707	Avellino
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 216153	Bologna
Italy	Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601	Meldola
Italy	Ospedale San Raffaele IRCCS /ID# 226973	Milan	Milano
Italy	AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 231948	Napoli
Italy	A.O.U. San Luigi Gonzaga /ID# 204706	Orbassano	Torino
Italy	Azienda Ospedaliero-Universitaria di Parma /ID# 204983	Parma
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 205163	Rome	Roma
Italy	Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 215918	Rome	Roma
Italy	IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 227011	Rome
Japan	Chiba University Hospital /ID# 232204	Chiba-shi	Chiba
Japan	National Cancer Center Hospital /ID# 205066	Chuo-ku	Tokyo
Japan	Fujieda Municipal General Hospital /ID# 248589	Fujieda-shi
Japan	National Hospital Organization Kyushu Cancer Center /ID# 206061	Fukuoka-shi	Fukuoka
Japan	Chugoku Central Hospital /ID# 245022	Fukuyama-shi	Hiroshima
Japan	Himeji Medical Center /ID# 227777	Himeji-shi	Hyogo
Japan	Hirosaki University Hospital /ID# 245023	Hirosaki-shi	Aomori
Japan	Hiroshima Citizens Hospital /ID# 218087	Hiroshima-shi
Japan	Saitama Cancer Center /ID# 232508	Kitaadachi-gun	Saitama
Japan	Kobe Minimally Invasive Cancer Center /ID# 248590	Kobe-shi	Hyogo
Japan	The Cancer Institute Hospital Of JFCR /ID# 216463	Koto-ku	Tokyo
Japan	Kurume University Hospital /ID# 227776	Kurume-shi	Fukuoka
Japan	Matsusaka Municipal Hospital /ID# 230219	Matsusaka-shi	Mie
Japan	National Hospital Organization Shikoku Cancer Center /ID# 232252	Matsuyama-shi	Ehime
Japan	Aichi Cancer Center Hospital /ID# 207790	Nagoya-shi	Aichi
Japan	Chukyo Hospital /ID# 244755	Nagoya-shi	Aichi
Japan	Niigata Cancer Center Hospital /ID# 216462	Niigata-shi	Niigata
Japan	Okayama University Hospital /ID# 227851	Okayama-shi	Okayama
Japan	Osaka City General Hospital /ID# 233172	Osaka-shi	Osaka
Japan	Osaka International Cancer Institute /ID# 210735	Osaka-shi	Osaka
Japan	Kinki-Chuo Chest Medical Center /ID# 216461	Sakai-shi	Osaka
Japan	Sendai Kousei Hospital /ID# 216460	Sendai-shi	Miyagi
Japan	Shizuoka Cancer Center /ID# 205065	Sunto-gun	Shizuoka
Japan	Takarazuka City Hospital /ID# 245185	Takarazuka-shi	Hyogo
Japan	Yamaguchi - Ube Medical Center /ID# 227778	Ube-shi	Yamaguchi
Japan	Kanagawa Cancer Center /ID# 205068	Yokohama-shi	Kanagawa
Japan	Yokohama Municipal Citizen's Hospital /ID# 248374	Yokohama-shi	Kanagawa
Korea, Republic of	Chungbuk National Univ Hosp /ID# 205680	Cheongju
Korea, Republic of	National Cancer Center /ID# 204241	Goyang	Gyeonggido
Korea, Republic of	Inha University Hospital /ID# 234206	Incheon
Korea, Republic of	Chonnam National University Hwasun Hospital /ID# 206951	Jeonnam
Korea, Republic of	Seoul National University Bundang Hospital /ID# 204237	Seongnam	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 204236	Seoul
Korea, Republic of	Samsung Medical Center /ID# 227083	Seoul
Korea, Republic of	The Catholic University of Korea, ST. Vincent's Hospital /ID# 229647	Suwon	Gyeonggido
Korea, Republic of	Pusan National University Yangsan Hospital /ID# 233871	Yangsan-si	Gyeongsangnamdo
Netherlands	Meander Medisch Centrum /ID# 217756	Amersfoort
Netherlands	Antoni van Leeuwenhoek /ID# 216657	Amsterdam	Noord-Holland
Netherlands	Ziekenhuis St. Jansdal /ID# 216658	Harderwijk
Poland	Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476	Lodz	Lodzkie
Poland	Med Polonia Sp. z o. o. /ID# 229908	Poznan	Wielkopolskie
Poland	Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960	Przemysl	Podkarpackie
Poland	Dom Lekarski S.A. /ID# 231479	Szczecin	Zachodniopomorskie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595	Warsaw	Mazowieckie
Puerto Rico	Puerto Rico Hematology Oncolog /ID# 206337	San Juan
Puerto Rico	VA Caribbean Healthcare System /ID# 206336	San Juan
Romania	Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216	Bucharest
Romania	S.C. Gral Medical Srl /Id# 227215	Bucharest
Romania	Spitalul Clinic Coltea /ID# 227241	Bucharest
Romania	Institutul Oncologic Prof Dr I Chiricuta /ID# 206320	Cluj Napoca
Romania	S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623	Craiova	Dolj
Romania	Spitalul Municipal Ploiesti /ID# 229097	Ploiesti	Prahova
Romania	Oncomed SRL /ID# 205616	Timisoara
Russian Federation	Arkhangelsk Clinical Oncology Dispensary /ID# 216418	Arkhangelsk
Russian Federation	Evimed Clinic /ID# 216473	Chelyabinsk
Russian Federation	Republican Clinical Oncology Dispensary /ID# 206463	Kazan	Tatarstan, Respublika
Russian Federation	Kostroma region oncology center /ID# 231317	Kostroma
Russian Federation	Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065	Krasnoyarsk	Krasnoyarskiy Kray
Russian Federation	Univercity Headache Clynic,LTD /ID# 212080	Moscow
Russian Federation	VitaMed LLC /ID# 228957	Moscow
Russian Federation	LLC Medical Center /ID# 212397	Novosibirsk	Novosibirskaya Oblast
Russian Federation	National Medical Research Radiological Centre /ID# 231263	Obninsk
Russian Federation	Clinical Oncology Dispensary of Omsk /ID# 239313	Omsk
Russian Federation	Euromedservice /ID# 206390	Pushkin
Russian Federation	Newclinic Medical Center /ID# 216262	Pyatigorsk
Russian Federation	St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405	Saint Petersburg	Sankt-Peterburg
Russian Federation	Center of Palliative Medicine De Vita /ID# 212900	St. Petersburg
Russian Federation	Regional Children's Clinical Hospital of Volgograd /ID# 206520	Volgograd	Volgogradskaya Oblast
Spain	Hospital Universitario Fundacion Alcorcon /ID# 232361	Alcorcon	Madrid
Spain	Hospital Nuestra Senora de Sonsoles /ID# 232367	Avila
Spain	Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106	Badalona	Barcelona
Spain	Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368	Barcelona
Spain	Hospital Universitario Vall d'Hebron /ID# 206997	Barcelona
Spain	CHU Insular-Materno Infantil /ID# 232362	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Universitario HM Sanchinarro /ID# 203913	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 203922	Madrid
Spain	Hospital Regional Universitario de Malaga /ID# 216081	Malaga
Spain	Hospital Clínico Universitario de Santiago-CHUS /ID# 204367	Santiago de Compostela	A Coruna
Spain	Hospital Universitario Virgen del Rocio /ID# 216058	Sevilla
Spain	Hospital Universitario Virgen Macarena /ID# 230998	Sevilla
Spain	Hospital Universitario y Politecnico La Fe /ID# 203862	Valencia
Switzerland	Universitätsspital Basel /ID# 230977	Basel	Basel-Stadt
Switzerland	KSW Kantonsspital Winterthur /ID# 231284	Winterthur	Zuerich
Taiwan	Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309	Chia-Yi
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831	Kaohsiung
Taiwan	Kaohsiung Chang Gung Memorial Hospital /ID# 205423	Kaohsiung City	Kaohsiung
Taiwan	Taipei Medical University Shuang Ho Hospital /ID# 215356	New Taipei City
Taiwan	Taichung Veterans General Hospital /ID# 205308	Taichung
Taiwan	National Cheng Kung University Hospital /ID# 205307	Tainan
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336	Taipei
Taiwan	National Taiwan University Hospital /ID# 205100	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 205424	Taoyuan City
Turkey	Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000	Adana
Turkey	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 205243	Ankara
Turkey	Gazi University Medical Faculty /ID# 239816	Ankara
Turkey	Akdeniz Universitesi Tip Fakul /ID# 205238	Antalya
Turkey	Trakya University Medical Facu /ID# 205242	Edirne, Istanbul
Turkey	Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 215082	Istanbul
Turkey	Dr. Suat Seren Gogus Has /ID# 215083	Izmir
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 206209	Birmingham
United Kingdom	Barts Health NHS Trust /ID# 239889	London	London, City Of
United Kingdom	University College London Hospitals NHS Foundation Trust /ID# 231467	London
United Kingdom	Nottingham University Hospitals NHS Trust /ID# 231224	Nottingham	Nottinghamshire
United Kingdom	Oxford University Hospitals NHS Foundation Trust /ID# 205890	Oxford	Oxfordshire
United States	University of New Mexico /ID# 208339	Albuquerque	New Mexico
United States	Univ of Colorado Cancer Center /ID# 203212	Aurora	Colorado
United States	St. Vincent Frontier Cancer Center /ID# 203292	Billings	Montana
United States	Beth Israel Deaconess Medical Center /ID# 208124	Boston	Massachusetts
United States	Dana-Farber Cancer Institute /ID# 203248	Boston	Massachusetts
United States	Massachusetts General Hospital /ID# 203215	Boston	Massachusetts
United States	Advanced Cancer Treatment Center /ID# 239565	Brooksville	Florida
United States	Gabrail Cancer Center Research /ID# 216056	Canton	Ohio
United States	AdventHealth Celebration /ID# 215649	Celebration	Florida
United States	Northwestern University Feinberg School of Medicine /ID# 203239	Chicago	Illinois
United States	The University of Chicago Medical Center /ID# 203216	Chicago	Illinois
United States	Univ Hosp Cleveland /ID# 215648	Cleveland	Ohio
United States	Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868	East Brunswick	New Jersey
United States	Mercy Cancer Center /ID# 231972	Elyria	Ohio
United States	NorthShore University HealthSystem /ID# 215583	Evanston	Illinois
United States	Virginia Cancer Specialists - Fairfax /ID# 203224	Fairfax	Virginia
United States	Goshen Center for Cancer Care /ID# 215584	Goshen	Indiana
United States	Ingalls Memorial Hosp /ID# 203228	Harvey	Illinois
United States	Hattiesburg Clinic /ID# 227691	Hattiesburg	Mississippi
United States	Penn State University and Milton S. Hershey Medical Center /ID# 221844	Hershey	Pennsylvania
United States	Straub Clinic and Hospital /ID# 217905	Honolulu	Hawaii
United States	Houston Methodist Hospital - Scurlock Tower /ID# 213268	Houston	Texas
United States	Mayo Clinic /ID# 218488	Jacksonville	Florida
United States	Joliet Oncology-Hematology Associates, LTD /ID# 203238	Joliet	Illinois
United States	St. Lukes Cancer Institute /ID# 227697	Kansas City	Missouri
United States	Univ Kansas Med Ctr /ID# 216804	Kansas City	Kansas
United States	Thompson Cancer Survival Ctr /ID# 228874	Knoxville	Tennessee
United States	Dartmouth-Hitchcock Medical Center /ID# 203350	Lebanon	New Hampshire
United States	Central Maine Medical Center /ID# 216583	Lewiston	Maine
United States	Baptist Health /ID# 203283	Lexington	Kentucky
United States	Rocky Mountain Cancer Centers /ID# 215789	Lone Tree	Colorado
United States	University of California, Los Angeles /ID# 203219	Los Angeles	California
United States	Norton Cancer Institute - St Matthews /ID# 203284	Louisville	Kentucky
United States	Medical College of Wisconsin /ID# 210062	Milwaukee	Wisconsin
United States	University of South Alabama /ID# 212939	Mobile	Alabama
United States	Atlantic Health System /ID# 203404	Morristown	New Jersey
United States	Vanderbilt Ingram Cancer Center /ID# 203281	Nashville	Tennessee
United States	Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC /ID# 230154	Oklahoma City	Oklahoma
United States	LA Hematology-Oncology Med Group /ID# 203338	Orange	California
United States	AdventHealth Cancer Institute - Orlando /ID# 239960	Orlando	Florida
United States	Capital Health Medical Center /ID# 203403	Pennington	New Jersey
United States	Mayo Clinic Arizona /ID# 218550	Phoenix	Arizona
United States	Allegheny General Hospital /ID# 215585	Pittsburgh	Pennsylvania
United States	Veterans Healthcare System /ID# 215602	Pittsburgh	Pennsylvania
United States	Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301	Portland	Oregon
United States	Valley Medical Center /ID# 231459	Renton	Washington
United States	Mayo Clinic - Rochester /ID# 215603	Rochester	Minnesota
United States	Sutter Medical Center Sacramen /ID# 203299	Sacramento	California
United States	Washington University-School of Medicine /ID# 203217	Saint Louis	Missouri
United States	University of Washington /ID# 206056	Seattle	Washington
United States	Highlands Oncology Group, PA /ID# 215600	Springdale	Arkansas
United States	Overlook Medical Center /ID# 211160	Summit	New Jersey
United States	Baylor Scott & White Medical Center- Temple /ID# 216578	Temple	Texas
United States	Henry Ford Hospital - West Bloomfield /ID# 203220	West Bloomfield	Michigan
United States	Icri /Id# 227835	Whittier	California
United States	Cancer Center of Kansas /ID# 203235	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  China,  Czechia,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) (Stage 1 and Stage 2)	ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.	Up to approximately 3 years
Primary	Number of Participants with Adverse Events (Alternate dose cohort)	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.	Up to approximately 3 years
Secondary	Duration of Response (DoR) (Stage 1 and Stage 2)	DoR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression determined by an independent central review or death from any cause for the responders.	Up to approximately 3 years
Secondary	Disease Control Rate (DCR) (Stage 1 and Stage 2)	DCR is defined as the percentage of participants with best overall response of confirmed CR, confirmed PR, or stable disease (SD) for at least 12 weeks following enrollment, based on RECIST, version 1.1.	Up to approximately 3 years
Secondary	Progression-Free Survival (PFS) (Stage 1 and Stage 2)	PFS is defined as the time from the participant's first dose of study drug until the first occurrence of radiographic progression determined by an independent central review or death from any cause.	Up to approximately 3 years
Secondary	Overall Survival (OS) (Stage 1 and Stage 2)	OS is defined as the time from the participant's first dose of study drug until death from any cause.	Up to approximately 3 years