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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Sponsor: Nuvalent Inc.
Summary
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors.
Official title: A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
840
Start Date
2022-06-09
Completion Date
2028-01
Last Updated
2025-10-30
Healthy Volunteers
No
Interventions
Neladalkib (NVL-655)
Oral Tablet of Neladalkib (NVL-655)
Locations (74)
University of California Irvine Medical Center
Orange, California, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
Stanford Cancer Institute
Stanford, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Miami; Sylvester Cancer Center
Miami, Florida, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
John Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
OSU Brain & Spine Hospital
Columbus, Ohio, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Royal North Shore Hospital
Sydney, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Universitair Ziekenhuis Antwerpen (UZA)
Antwerp, Belgium
Universitaire Ziekenhuizen Leuven Campus Gastthuisberg
Leuven, Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer Center
Vancouver, British Columbia, Canada
The Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Leon Berard
Lyon, France
Chu De Nantes
Nantes, France
Institut Claudius Regaud
Toulouse, France
Institute Gustave Roussy
Villejuif, France
Universitatsklinikum Koln - University Hospital Cologne
Cologne, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany
Universkitatsklinikum Heidelberg - University Hospital Heidelberg
Heidelberg, Germany
Azienda Ospedaliera Universitaria Ospedali Riuniti Umberto
Ancona, Italy
IRCCS Istituto Tumori "G. Paolo II"
Bari, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Instituto Europeo di Oncologia
Milan, Italy
Instituto Oncologico Veneto
Padova, Italy
Ospedale Santa Maria delle Croci
Ravenna, Italy
Regina Elena Institute for Cancer Research
Rome, Italy
Kanagawa Cancer Center
Kanagawa, Japan
Okayama University Hospital
Okayama, Japan
Kindai University Hospital
Osaka, Japan
Shizuoka Cancer Center
Shizuoka, Japan
National Cancer Center Hospital
Tokyo, Japan
Cancer Institute Hospital of JFCR
Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Japan
The Netherlands Cancer Institute
Amsterdam, Netherlands
University Medical Center Groningen (UMCG)
Groningen, Netherlands
National University Hospital
Singapore, Singapore, Singapore
National Cancer Centre Singapore
Singapore, Singapore, Singapore
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Complejo Hospitalario Universitario de A Coruna
A Coruña, Spain
UOMI Cancer Center
Barcelona, Spain
Vall d'Hebron
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Istituto Oncologico Svizzera Italiana
Bellinzona, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
Chung-Shan Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Edinburgh Cancer Centre
Edinburgh, United Kingdom
The Royal Marsden - Chelsea
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom