Spots Global Cancer Trial Database for Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
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Trial Identification
Brief Title: Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Official Title: Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Study ID: NCT05245071
Conditions
Interventions
Study Description
Brief Summary: This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA). Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.
Detailed Description: 40 weeks (up to 4 weeks for screening, a median of 24 weeks for treatment, and a median of 12 weeks for end of treatment assessments and the safety follow-up visit).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Roswell Park Cancer Institute Site Number : 8400004, Buffalo, New York, United States
Renovatio Clinical Site Number : 8400003, El Paso, Texas, United States
Investigational Site Number : 0560003, Edegem, , Belgium
Investigational Site Number : 0560001, Leuven, , Belgium
Investigational Site Number : 0560002, Liege, , Belgium
Investigational Site Number : 2500003, Bordeaux, , France
Investigational Site Number : 2500001, Creteil, , France
Investigational Site Number : 2500007, Marseille, , France
Investigational Site Number : 2500005, Montpellier, , France
Investigational Site Number : 2500002, RENNES Cedex 09, , France
Investigational Site Number : 2500006, Saint Herblain, , France
Investigational Site Number : 2500008, Saint-mande, , France
Investigational Site Number : 2500009, Villejuif, , France
Investigational Site Number : 3800003, Ravenna, Emilia-Romagna, Italy
Investigational Site Number : 3800004, Aviano (PN), Friuli-Venezia Giulia, Italy
Investigational Site Number : 3800001, Rozzano, Lombardia, Italy
Investigational Site Number : 3800002, Milano, , Italy
Investigational Site Number : 3920002, Nagoya-shi, Aichi, Japan
Investigational Site Number : 3920001, Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920005, Hirakata-shi, Osaka, Japan
Investigational Site Number : 3920003, Sunto Gun, Shizuoka, Japan
Investigational Site Number : 7240004, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240001, Hospitalet de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240009, Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240002, Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240008, Majadahonda, Madrid, Spain
Investigational Site Number : 7240003, Málaga, , Spain
Investigational Site Number : 7240005, Sevilla, , Spain
Investigational Site Number : 7240007, Valencia, , Spain
Investigational Site Number : 7920002, Adana, , Turkey
Investigational Site Number : 7920005, Ankara, , Turkey
Investigational Site Number : 7920003, Istanbul, , Turkey
Investigational Site Number : 7920004, Istanbul, , Turkey
Investigational Site Number : 7920001, Malatya, , Turkey
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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