{"id":1854,"date":"2020-02-26T21:33:00","date_gmt":"2020-02-27T02:33:00","guid":{"rendered":"https:\/\/nanobiotix.com\/resource\/asco-sitc-nbtxr3-with-anti-pd-1-therapy\/"},"modified":"2024-10-29T08:50:20","modified_gmt":"2024-10-29T12:50:20","slug":"asco-sitc-nbtxr3-with-anti-pd-1-therapy","status":"publish","type":"resource","link":"https:\/\/nanobiotix.com\/fr\/resource\/asco-sitc-nbtxr3-with-anti-pd-1-therapy\/","title":{"rendered":"ASCO-SITC &#8211; NBTXR3 with anti-PD-1 therapy"},"content":{"rendered":"<p>[vc_row padding_top=&#8221;0&#8243; padding_bottom=&#8221;0&#8243; section_container_layout=&#8221;full-width&#8221; remove_horizontal_padding=&#8221;yes&#8221; module_type=&#8221;bg-color&#8221; gutter_size=&#8221;yes&#8221; equal_height=&#8221;yes&#8221; bg_color=&#8221;#28282e&#8221;][vc_column][vc_row_inner padding_top=&#8221;0&#8243; padding_bottom=&#8221;0&#8243; gutter_size=&#8221;yes&#8221; equal_height=&#8221;yes&#8221;][vc_column_inner column_paddings=&#8221;105&#8243; column_position_vertical=&#8221;middle&#8221; column_min_height=&#8221;700&#8243; column_min_height_sm=&#8221;400&#8243; column_min_height_xs=&#8221;350&#8243; module_type=&#8221;bg-image&#8221; bg_image=&#8221;99&#8243; mask_fx=&#8221;yes-mask&#8221; mask_color_mode=&#8221;palette&#8221; mask_bg_color_palette=&#8221;main-mask&#8221; animation_fx=&#8221;yes-animation&#8221; animation_delay=&#8221;200&#8243; animation_offset_scroll_down=&#8221;90&#8243; width=&#8221;1\/2&#8243; animation_in=&#8221;fadeInUp&#8221;][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][az_box_icons box_icon_title=&#8221;Authors&#8221; box_icon_color_mode=&#8221;on-the-fly&#8221; icon_visibility=&#8221;yes-icon&#8221; icon_type=&#8221;font&#8221; icon=&#8221;fa fa-edit&#8221; icon_color_mode=&#8221;on-the-fly&#8221; icon_size=&#8221;50&#8243; box_icon_color=&#8221;#ffffff&#8221; icon_color=&#8221;#ffffff&#8221;]Colette Shen<span class=\"notes up\">1<\/span>, Katherine Jameson<span class=\"notes up\">2<\/span>, Jared Weiss<span class=\"notes up\">1<\/span>, Trevor Hackman<span class=\"notes up\">1<\/span>, Robert Dixon<span class=\"notes up\">1<\/span>, Jason A. Akulian<span class=\"notes up\">1<\/span>, Alexander Pearson<span class=\"notes up\">3<\/span>, Jessica Frakes<span class=\"notes up\">4<\/span>, Patricia Said<span class=\"notes up\">2<\/span>, Tanguy Seiwert<span class=\"notes up\">5<\/span> <span class=\"notes\"> 1 &#8211; University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA 2 &#8211; Nanobiotix, Paris, France 3 &#8211; University of Chicago Medicine, Chicago, Illinois, USA 4 &#8211; Moffitt Cancer Center, Tampa, Florida, USA 5 &#8211; Johns Hopkins Medicine, Baltimore, Maryland, USA <\/span>[\/az_box_icons][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][\/vc_column_inner][vc_column_inner column_paddings=&#8221;105&#8243; column_position_vertical=&#8221;middle&#8221; module_type=&#8221;bg-color&#8221; animation_fx=&#8221;yes-animation&#8221; animation_delay=&#8221;300&#8243; animation_offset_scroll_down=&#8221;90&#8243; width=&#8221;1\/2&#8243; bg_color=&#8221;#ffffff&#8221; animation_in=&#8221;fadeInUp&#8221;][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][az_box_icons box_icon_title=&#8221;Summary&#8221; icon_visibility=&#8221;yes-icon&#8221; icon_type=&#8221;font&#8221; icon=&#8221;az-icon az-icon-layers2&#8243; icon_color_mode=&#8221;on-the-fly&#8221; icon_color=&#8221;#28282e&#8221; icon_size=&#8221;50&#8243;]<strong>Background:<\/strong> Most cancer patients present resistance to immune therapy; only approximately 15% of patients respond to immune checkpoint inhibitors (ICI). Strategies able to increase ICI response are thus of great interest. Radiotherapy (RT), by acting as an immunomodulator is a good candidate to increase the proportion of ICI responders. However, RT dose and ultimate efficacy are limited by potential toxicity to healthy tissues. NBTXR3, a first in class radioenhancer administered by intratumoral injection, has been designed at the nanoscale to increase RT energy dose deposition within the tumor. The result is increased radiation-dependent tumor cell killing, without increasing radiation exposure of healthy tissues. Preclinical and early clinical data suggest NBTXR3 activated by RT can increase the anti-tumor response yielding both local and systemic (abscopal) effects. We hypothesize that NBTXR3 activated by RT, in combination with anti-PD-1 therapy (R3\/RT\/PD-1), will act synergistically to maximize the local RT effect while also producing a systemic effect sufficient to increase the proportion of ICI responders or convert ICI non-responders to responders.  <strong>Methods:<\/strong> NANORAY-1100 [NCT03589339] is a multicenter, open-label, phase 1 study to evaluate safety and tolerability of R3\/RT\/PD-1 in three cohorts: (1) Locoregionally recurrent or recurrent and metastatic head and neck squamous cell carcinoma (HNSCC) amenable to re-irradiation of the HN field, (2) Lung metastases from any primary cancer eligible for anti-PD-1, or (3) Liver metastases from any primary cancer eligible for anti-PD-1. Approximately two-thirds of each cohort will be composed of anti-PD-1 non-responders and one-third will be anti-PD-1-na\u00efve. NBTXR3 injection volume is based on a percentage of gross tumor volume (GTV) determined by central review. The primary objective is to determine R3\/RT\/PD-1 RP2D. Secondary objectives are to evaluate anti-tumor response (objective response rate; ORR) of R3\/RT\/PD-1, safety and feasibility of NBTXR3 injection, and NBTXR3 body kinetic profile. Exploratory objectives will assess biomarkers of R3\/RT\/PD-1 response, including PD-L1 status by IHC, mRNA and cytokine immune marker profiling.[\/az_box_icons][vc_empty_space height=&#8221;60px&#8221; responsive_lg=&#8221;hidden&#8221; responsive_md=&#8221;hidden&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n","protected":false},"featured_media":0,"menu_order":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"wds_primary_resource_type":0,"wds_primary_data_type":0,"wds_primary_indication":0,"wds_primary_platform_type":0,"footnotes":""},"resource_type":[31],"data_type":[25],"indication":[26,32,34],"platform_type":[36],"class_list":["post-1854","resource","type-resource","status-publish","hentry","resource_type-abstracts","data_type-clinical","indication-head-neck","indication-liver","indication-lung","platform_type-nbtxr3"],"acf":[],"_links":{"self":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource\/1854","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource"}],"about":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/types\/resource"}],"version-history":[{"count":0,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource\/1854\/revisions"}],"wp:attachment":[{"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=1854"}],"wp:term":[{"taxonomy":"resource_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/resource_type?post=1854"},{"taxonomy":"data_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/data_type?post=1854"},{"taxonomy":"indication","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/indication?post=1854"},{"taxonomy":"platform_type","embeddable":true,"href":"https:\/\/nanobiotix.com\/fr\/wp-json\/wp\/v2\/platform_type?post=1854"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}