EXCLUSIVE: GT Biopharma Plans 2026 Trial For New Cancer Treatment

Benzinga_recent_news01-15

GT Biopharma Inc. (NASDAQ:GTBP) on Thursday said it submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in December 2025 for GTB-5550 TriKE for solid...

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(NASDAQ:GTBP) on Thursday said it submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in December 2025 for GTB-5550 TriKE for solid...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/26/01/49931692/exclusive-gt-biopharma-plans-2026-trial-for-new-cancer-treatment\">Source Link</a>\n\n</div>\n","source":"benzinga_recent_news","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>EXCLUSIVE: GT Biopharma Plans 2026 Trial For New Cancer Treatment</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nEXCLUSIVE: GT Biopharma Plans 2026 Trial For New Cancer Treatment\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-01-15 21:01 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/news/fda/26/01/49931692/exclusive-gt-biopharma-plans-2026-trial-for-new-cancer-treatment><strong>Benzinga_recent_news</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>GT Biopharma Inc. (NASDAQ:GTBP) on Thursday said it submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in December 2025 for GTB-5550 TriKE for solid...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/26/01/49931692/exclusive-gt-biopharma-plans-2026-trial-for-new-cancer-treatment\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU2413666699.HKD","symbol_name":"BNP PARIBAS GLOBAL ENVIRONMENT \"CRH\" (HKDHDG) INC","start_time":0,"source_url":"https://www.benzinga.com/news/fda/26/01/49931692/exclusive-gt-biopharma-plans-2026-trial-for-new-cancer-treatment","article_id":"2603071600","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2026/01/15/cancer.jpeg?optimize=medium&dpr=2&auto=webp&width=240"],"rights":{"source":"benzinga_recent_news","url":"https://www.benzinga.com/news/fda/26/01/49931692/exclusive-gt-biopharma-plans-2026-trial-for-new-cancer-treatment","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2603071600","pubTimestamp":1768482060,"columns":[],"sourceInfo":{"source_id":"benzinga_recent_news","name":"Benzinga"},"weMediaInfo":null,"summary":"GT Biopharma submitted an IND application for GTB-5550 TriKE for solid tumors. Phase 1 trial planned for 2026.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU2413666699.HKD":"BNP PARIBAS GLOBAL ENVIRONMENT \"CRH\" (HKDHDG) INC","BK4585":"ETF&股票定投概念","BK4567":"ESG概念","BK4139":"生物科技","BK4533":"AQR资本管理(全球第二大对冲基金)","IE00BYQQ9H92.USD":"BNY MELLON GLOBAL LEADERS \"A\" (USD) ACC","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","LU2211817866.USD":"Allianz Food Security AT Acc USD","OS":"OneStream, Inc.","BK4119":"轮胎与橡胶","MTD":"梅特勒-托利多","GTBP":"GT Biopharma Inc.","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","BK4588":"碎股","BK4548":"巴美列捷福持仓","IE00BFXG0V08.USD":"BNY MELLON GLOBAL LEADERS \"B\" (USD) ACC","LU0347712357.USD":"BNP PARIBAS GLOBAL ENVIRONMENT \"C\" (USD) ACC","LU1721428933.USD":"法巴全球经典环境基金RH MD Dis","LU2413666426.HKD":"BNP PARIBAS GLOBAL ENVIRONMENT \"C\" (HKD) ACC","BK4211":"区域性银行","GT":"固特异轮胎橡胶公司","BK4097":"系统软件","BK4195":"互助储蓄与抵押信贷金融服务","BK4121":"生命科学工具和服务","IND":"Xtrackers Nifty 500 India ETF","IE00B5TLWC47.USD":"BNY MELLON LONG-TERM GLOBAL EQUITY \"B\" (USD) ACC","PFS":"Provident Financial Services Inc"},"translate_title":"独家：GT Biopharma计划2026年进行新癌症治疗试验","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"GT":1.5,"OS":1,"PFS":1,"GTBP":1,"IND":1,"MTD":1},"content_text":"GT Biopharma Inc. (NASDAQ:GTBP) on Thursday said it submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in December 2025 for GTB-5550 TriKE for solid tumors.\nGTB-5550 TriKE is a B7-H3-targeted natural killer (NK) cell engager for B7-H3-expressing solid tumor cancers.\n\"The IND for GTB-5550 represents the third NK cell engager we plan to move into clinical development and a tremendous accomplishment for the company\", said Michael Breen, Executive Chairman and CEO of GT Biopharma.\nInitiation of a Phase 1 basket trial with GTB-5550 for multiple solid tumors is planned for 2026. The company looks forward to applying the clinical learnings from the GTB-3650 study to help inform the GTB-5550 program, which targets a patient population with B7-H3-expressing solid tumors.\nThe company is actively enrolling the Phase 1 trial with GTB-3650 in myeloid blood cancer, and expects the next data readout in the first half of 2026 that could provide potential evidence of clinical activity.\n“The global market for B7-H3 expressing solid tumor cancers accounts for a portion of the estimated $362 billion global solid tumor cancers market…,” Breen said in a press release on Thursday.\nThe Phase 1a dose escalation portion of the trial will test up to 7 dose levels to identify the maximum tolerated dose (MTD).\nThe Phase 1b dose expansion component of the trial will confirm the MTD identified in the Phase 1a trial across 7 distinct metastatic disease cohorts, and further evaluate its tolerability, assuming the toxicity rates are similar across the groups.\nGTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2, followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration.\nA minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient.\nPatients are followed for 12 months to determine progression-free survival (PFS) and overall survival (OS).\nPrice Action: GTBP stock is up 12.92% at $0.75 during the premarket session at the last check on Thursday.\nPhoto by Aunt Spray via Shutterstock","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.36.1","shortVersion":"4.36.1","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2603071600","isCrawlerRequest":true}