{"id":9928,"date":"2024-05-23T16:48:50","date_gmt":"2024-05-23T14:48:50","guid":{"rendered":"https:\/\/www.icta.fr\/?post_type=casclients&p=9928"},"modified":"2026-01-14T10:26:14","modified_gmt":"2026-01-14T09:26:14","slug":"a-first-in-human-trial-of-monoclonal-antibody-imp-in-patients-with-anti-mullerian-hormone-receptor-ii-amhrii-positive-gynecological-cancers","status":"publish","type":"casclients","link":"https:\/\/www.icta.fr\/fr\/cas-clients\/a-first-in-human-trial-of-monoclonal-antibody-imp-in-patients-with-anti-mullerian-hormone-receptor-ii-amhrii-positive-gynecological-cancers\/","title":{"rendered":"A First-In-Human trial of monoclonal antibody IMP in patients with Anti-M\u00fcllerian-Hormone-Receptor II (AMHRII) positive gynecological cancers"},"content":{"rendered":"\n
<\/div>
\n

OBJECTIVES<\/h3>\n\n\n\n
\n
\n

CO-PRIMARY OBJECTIVES<\/h4>\n\n\n\n

<\/p>\n\n\n\n

    \n
  • Phase Ia: to determine the recommended phase II dose (RP2D)<\/li>\n\n\n\n
  • Phase Ib: to characterize the safety profile<\/li>\n<\/ul>\n\n\n\n

    EXPLORATORY OBJECTIVES<\/strong><\/p>\n\n\n\n

      \n
    • Describe the tumor growth rate<\/li>\n\n\n\n
    • Document potential pharmacodynamics<\/li>\n\n\n\n
    • Assess potential circulating biomarkers predictive of sensitivity<\/li>\n\n\n\n
    • Identify any other biomarkers predictive of tumor response to IMP<\/li>\n<\/ul>\n<\/div>\n\n\n\n
      \n

      SECONDARY OBJECTIVES<\/h4>\n\n\n\n

      <\/p>\n\n\n\n

        \n
      • Assess the pharmacokinetics parameters<\/li>\n\n\n\n
      • Characterize the safety profile in monotherapy and in combination with chemotherapy<\/li>\n\n\n\n
      • Evaluate anti-tumor activity<\/li>\n\n\n\n
      • Assess the potential immunogenicity<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
        \n
        \n

        SCIENTIFIC and DATA vALORISATION<\/h3>\n\n\n\n
          \n
        • Poster presentation at ASCO 2018 & 2019<\/li>\n\n\n\n
        • Poster presentation at EORTC, NCI, AACR join meeting 2018<\/li>\n<\/ul>\n<\/div>\n\n\n\n
          \n

          Key factors of success<\/strong><\/h3>\n\n\n\n
            \n
          • ICTA\u2019s rigorousness<\/li>\n\n\n\n
          • ICTA\u2019s capability to propose innovative solutions for uncommon projects<\/li>\n\n\n\n
          • ICTA\u2019s responsiveness and ability to develop adapted IT tools in a fast-paced and multidisciplinary environment.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
            \n
            \n

            LESSONS LEARNED to speed up the start-up phase of the next study<\/h3>\n\n\n\n
              \n
            • The importance of a close collaboration between ICTA and Sponsor in order to allow for optimal anticipation of the Sponsor needs, particularly in term of IT tool development<\/li>\n\n\n\n
            • An accurate and reactive site management to closely follow each inclusion.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n

              CHALLENGES<\/h3>\n\n\n\n
              KEY CHALLENGES<\/th>ICTA’s SOLUTIONS<\/th>ICTA’s ACHIEVEMENTS<\/th><\/tr><\/thead>
              Study implementation<\/strong>
              Multicenter FIH study carried out in 3 countries


              <\/td>
              Regulatory submissions and sites management in 3 European countries, France, Belgium, The United Kingdom <\/strong>thanks to ICTA\u2019s European network of partners


              <\/td>              		Successful implementation of the study in the targeted sites and countries within the expected timelines, with 95 % active sites
              + Close collaboration with Gynecological network of investigators in France<\/td><\/tr>
              Site follow-up <\/strong>during dose escalation phase due to very tight timelines


              <\/td>              		Close follow up of the sites on a daily basis for patient slots allocation, PK\/PD samples handling.
              Detailed weekly status reports provided to sponsor<\/td>              		Up-to-date data provided to all SRC meetings and green lights obtained for this FIH phase Ia\/Ib dose escalation
              \u00a0
              Targeted timelines achieved to trigger Phase II trial in the expected timelines

              <\/td><\/tr>
              Study design<\/strong>
              Modification of the study design further to Safety Review Committee (SRC) meeting
              Addition of new cohorts with different treatment schemes<\/td>              		Adaptation of the eCRF thanks to ICTA in-house EDC system and internal Biometrics and IT development teams<\/td>Up-to-date data provided to all SRC meetings and green lights obtained for this FIH phase Ia\/Ib dose escalation
              \u00a0
              Targeted timelines achieved to trigger Phase II trial in the expected timelines<\/td><\/tr>
              Budget optimisation required since in the context of the IMP sale to another firm<\/strong><\/td>Drafting of an abbreviated final CSR without appendixes<\/td>Drafting of one statistical report at the end of phase Ia and a final CSR at the end of the study<\/td><\/tr>
              <\/td><\/td><\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div><\/section>\n\n\n\n
                \n
              • <\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":15,"featured_media":10783,"template":"","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","inline_featured_image":false,"_uag_custom_page_level_css":"","kk_blocks_editor_width":"","_kiokenblocks_attr":"","_kiokenblocks_dimensions":"","footnotes":""},"categories":[],"class_list":["post-9928","casclients","type-casclients","status-publish","has-post-thumbnail","hentry"],"acf":[],"uagb_featured_image_src":{"full":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer.jpg",1024,512,false],"thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer-128x88.jpg",128,88,true],"medium":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer-300x150.jpg",300,150,true],"medium_large":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer-768x384.jpg",768,384,true],"large":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer.jpg",1024,512,false],"1536x1536":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer.jpg",1024,512,false],"2048x2048":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer.jpg",1024,512,false],"post-thumbnail":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer.jpg",1024,512,false],"wpm_taille_1":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer-364x257.jpg",364,257,true],"wpm_taille_slider":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer-240x145.jpg",240,145,true],"gform-image-choice-sm":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer.jpg",300,150,false],"gform-image-choice-md":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer.jpg",400,200,false],"gform-image-choice-lg":["https:\/\/www.icta.fr\/wp-content\/uploads\/gynecologic-cancer.jpg",600,300,false]},"uagb_author_info":{"display_name":"Manon ROBERT","author_link":"https:\/\/www.icta.fr\/fr\/author\/mrobert-icta21\/"},"uagb_comment_info":0,"uagb_excerpt":null,"_links":{"self":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/9928","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients"}],"about":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/types\/casclients"}],"author":[{"embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/users\/15"}],"version-history":[{"count":1,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/9928\/revisions"}],"predecessor-version":[{"id":9929,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/casclients\/9928\/revisions\/9929"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media\/10783"}],"wp:attachment":[{"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/media?parent=9928"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.icta.fr\/fr\/wp-json\/wp\/v2\/categories?post=9928"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}