{"id":42232,"date":"2025-09-25T12:54:09","date_gmt":"2025-09-25T04:54:09","guid":{"rendered":"https:\/\/flcube.com\/?p=42232"},"modified":"2025-09-25T12:54:10","modified_gmt":"2025-09-25T04:54:10","slug":"fibrogen-launches-phase-2-dose%e2%80%91optimization-trial-for-cd46%e2%80%91targeted-adc-fg%e2%80%913246-in-metastatic-castration%e2%80%91resistant-prostate-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=42232","title":{"rendered":"FibroGen Launches Phase\u202f2 Dose\u2011Optimization Trial for CD46\u2011Targeted ADC FG\u20113246 in Metastatic Castration\u2011Resistant Prostate Cancer"},"content":{"rendered":"\n<p><strong>FibroGen, Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/FGEN:NASDAQ\">NASDAQ: FGEN<\/a>)<\/strong> announced today the start of a randomized, open\u2011label Phase\u202f2 monotherapy trial (NCT06842498) evaluating <strong>FG\u20113246<\/strong>, a first\u2011in\u2011class antibody\u2011drug conjugate (ADC) that targets CD46\u2011expressing tumor lesions in patients with metastatic castration\u2011resistant prostate cancer (mCRPC). The study also incorporates <strong>FG\u20113180<\/strong>, a companion PET imaging agent that shares the same CD46\u2011specific antibody, to assess its diagnostic and predictive performance.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-trial-design-amp-objectives\">Trial Design &amp; Objectives<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Element<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Phase<\/strong><\/td><td>2 (dose\u2011optimization)<\/td><\/tr><tr><td><strong>Population<\/strong><\/td><td>75 mCRPC patients who progressed after androgen\u2011receptor\u2011signaling\u2011inhibitor (ARSI) therapy and have not received chemotherapy<\/td><\/tr><tr><td><strong>Randomization<\/strong><\/td><td>3 dose arms (dose\u2011level 1, 2, 3)<\/td><\/tr><tr><td><strong>Primary Endpoint<\/strong><\/td><td>Determination of the optimal dose for Phase\u202f3 based on efficacy, safety, and PK<\/td><\/tr><tr><td><strong>Secondary Endpoints<\/strong><\/td><td>\u2022 Radiographic progression\u2011free survival (rPFS)<br>\u2022 PSA\u202f50 response<br>\u2022 PSA\u202f90 response<\/td><\/tr><tr><td><strong>Interim Analysis<\/strong><\/td><td>Planned after 12 patients per arm complete 12\u202fweeks or discontinue; expected in H2\u202f2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-fg-3246-first-in-class-cd46-targeted-adc\">FG\u20113246: First\u2011In\u2011Class CD46\u2011Targeted ADC<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mechanism<\/strong> \u2013 FG\u20113246 couples a humanized anti\u2011CD46 antibody to a potent cytotoxic payload, delivering the drug directly to CD46\u2011positive tumor cells while sparing normal tissue.<\/li>\n\n\n\n<li><strong>Preclinical Data<\/strong> \u2013 Demonstrated robust tumor\u2011cell killing in CD46\u2011expressing prostate and other solid\u2011tumor models, with a favorable safety profile.<\/li>\n\n\n\n<li><strong>Clinical Promise<\/strong> \u2013 If successful, FG\u20113246 could become the first ADC approved for mCRPC, a disease with limited post\u2011ARSI therapeutic options.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-fg-3180-companion-pet-imaging-agent\">FG\u20113180: Companion PET Imaging Agent<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Design<\/strong> \u2013 FG\u20113180 utilizes the same CD46\u2011specific antibody as FG\u20113246, labeled with a positron\u2011emitting radionuclide for high\u2011resolution imaging.<\/li>\n\n\n\n<li><strong>Purpose<\/strong> \u2013 To identify CD46\u2011positive lesions, quantify tumor burden, and predict which patients are most likely to respond to FG\u20113246 therapy.<\/li>\n\n\n\n<li><strong>Potential Impact<\/strong> \u2013 Provides a precision\u2011medicine framework, aligning diagnostics with targeted therapy\u2014a key trend in oncology drug development.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-amp-strategic-context\">Market &amp; Strategic Context<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The global prostate\u2011cancer therapeutics market is projected to exceed <strong>$20\u202fbillion<\/strong> by 2030, driven by unmet needs in the mCRPC space.<\/li>\n\n\n\n<li>ADCs have emerged as a transformative modality, with recent approvals for HER2\u2011positive breast cancer and HER2\u2011negative breast cancer.<\/li>\n\n\n\n<li>FibroGen\u2019s dual\u2011agent strategy positions the company to capture both therapeutic and diagnostic revenue streams, potentially accelerating regulatory approval and market adoption.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h2>\n\n\n\n<p>FibroGen cautions that the Phase\u202f2 trial results will inform dose selection for a planned Phase\u202f3 study and that clinical and regulatory milestones are subject to change based on emerging data.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>FibroGen, Inc. (NASDAQ: FGEN) announced today the start of a randomized, open\u2011label Phase\u202f2 monotherapy trial&#8230;<\/p>\n","protected":false},"author":1,"featured_media":42233,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[35,62,444,964,25],"class_list":["post-42232","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-clinical-trial-approval-initiation","tag-fibrogen","tag-nasdaq-fgen","tag-potential-first-in-class"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FibroGen Launches Phase\u202f2 Dose\u2011Optimization Trial for CD46\u2011Targeted ADC FG\u20113246 in Metastatic Castration\u2011Resistant Prostate Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"FibroGen, Inc. (NASDAQ: FGEN) announced today the start of a randomized, open\u2011label Phase\u202f2 monotherapy trial (NCT06842498) evaluating FG\u20113246, a first\u2011in\u2011class antibody\u2011drug conjugate (ADC) that targets CD46\u2011expressing tumor lesions in patients with metastatic castration\u2011resistant prostate cancer (mCRPC). 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(NASDAQ: FGEN) announced today the start of a randomized, open\u2011label Phase\u202f2 monotherapy trial (NCT06842498) evaluating FG\u20113246, a first\u2011in\u2011class antibody\u2011drug conjugate (ADC) that targets CD46\u2011expressing tumor lesions in patients with metastatic castration\u2011resistant prostate cancer (mCRPC). 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(NASDAQ: FGEN) announced today the start of a randomized, open\u2011label Phase\u202f2 monotherapy trial (NCT06842498) evaluating FG\u20113246, a first\u2011in\u2011class antibody\u2011drug conjugate (ADC) that targets CD46\u2011expressing tumor lesions in patients with metastatic castration\u2011resistant prostate cancer (mCRPC). The study also incorporates FG\u20113180, a companion PET imaging agent that shares the same CD46\u2011specific antibody, to assess its diagnostic and predictive performance.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=42232#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=42232"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=42232#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2504.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2504.webp","width":1080,"height":608,"caption":"FibroGen Launches Phase\u202f2 Dose\u2011Optimization Trial for CD46\u2011Targeted ADC FG\u20113246 in Metastatic Castration\u2011Resistant Prostate Cancer"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=42232#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"FibroGen Launches Phase\u202f2 Dose\u2011Optimization Trial for CD46\u2011Targeted ADC FG\u20113246 in Metastatic Castration\u2011Resistant Prostate Cancer"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/09\/2504.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/42232","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=42232"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/42232\/revisions"}],"predecessor-version":[{"id":42234,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/42232\/revisions\/42234"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/42233"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=42232"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=42232"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=42232"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}