Spots Global Cancer Trial Database for Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies
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Trial Identification
Brief Title: Study of INCA32459 a LAG-3 and PD-1 Bispecific Antibody in Participants With Select Advanced Malignancies
Official Title: A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants With Select Advanced Malignancies
Study ID: NCT05577182
Conditions
Interventions
Study Description
Brief Summary: This is a multicenter, open-label, single-arm study to investigate the safety, tolerability, PK, pharmacodynamics and preliminary activity of INCA32459 in participants with selected advanced malignancies. Part 1 (dose escalation) will determine the recommended dose of INCA 32459 for expansion (RDE) and the maximum tolerated dose (MTD). Part 2 (dose expansion) will further evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of INCA 32459 at the recommended dose(s) for expansion in 2 tumor-specific cohorts.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Angeles Clinic and Research Institute, Los Angeles, California, United States
University of Texas Md Anderson Cancer Center, Houston, Texas, United States
Cliniques Universitaires Ucl Saint-Luc, Bruxelles, , Belgium
Universitair Ziekenhuis Antwerpen (Uza), Edegem, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Universitair Ziekenhuis Brussel, Jette, , Belgium
Chu Ucl Namur University Hospital Mont-Godinne, Yvoir, , Belgium
Centre Leon Berard, Lyon, , France
Chu Hopital de La Timone, Marseille Cedex 5, , France
Institut Curie, Paris Cedex 05, , France
Hospital Saint Louis, Paris, , France
Centre Eugene Marquis, Rennes Cedex, , France
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole, Toulouse, , France
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milano, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale, Napoli, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte, Siena, , Italy
Centro Ricerche Cliniche Di Verona (Crc), Verona, , Italy
Hospital Quironsalud Barcelona, Barcelona, , Spain
Ico Institut Catala D Oncologia, L'hospitalet de Llobregat, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
Hospital Universitario Virgen de La Victoria, Málaga, , Spain
Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Contact Details
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