{"entity":{"id":"aldoxorubicin","kind":"drug","name":"Aldoxorubicin","aka":["INNO-206","DOXO-EMCH","Aldox"],"tldr":"Aldoxorubicin is doxorubicin, the workhorse chemotherapy nicknamed the red devil, attached to a linker that hitches it to the body's own albumin so more reaches the tumour and less reaches the heart; it beat doxorubicin in a randomised phase 2 sarcoma trial but missed the primary endpoint of its phase 3, and a new company is now trying to finish its development.","summary":"Aldoxorubicin was invented by Felix Kratz at the Tumor Biology Center in Freiburg and developed by CytRx. In a randomised phase 2b trial of 140 patients with previously untreated advanced soft tissue sarcoma, it improved progression-free survival over doxorubicin (median 5.6 versus 2.7 months) and allowed cumulative doxorubicin-equivalent doses far above the usual cardiac ceiling. The 433-patient phase 3 trial in relapsed soft tissue sarcoma compared it with investigator's choice of dacarbazine, pazopanib, gemcitabine with docetaxel, doxorubicin or ifosfamide and did not meet its primary progression-free survival endpoint, and CytRx licensed the drug to ImmunityBio in 2017, which has tested it with its IL-15 agonist in pancreatic cancer. Gemini Therapeutics, formed after the GitLab co-founder Sid Sijbrandij was treated with doxorubicin for osteosarcoma, took up the programme and presented integrated analyses at ASCO 2026 reporting higher tumour exposure than doxorubicin and better preserved cardiac function across the randomised sarcoma studies. It is not approved anywhere.","status":"phase-3","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Aldoxorubicin","links":[{"label":"Chawla et al., first-line aldoxorubicin vs doxorubicin in advanced soft tissue sarcoma, phase 2b (JAMA Oncology 2015)","url":"https://doi.org/10.1001/jamaoncol.2015.3101"},{"label":"Phase 3 trial NCT02049905 on ClinicalTrials.gov","url":"https://clinicaltrials.gov/study/NCT02049905"},{"label":"Gemini Therapeutics: aldoxorubicin","url":"https://www.geminithera.com/aldoxorubicin.html"},{"label":"Cardiac safety of aldoxorubicin vs doxorubicin, integrated analysis (ASCO 2026 abstract 11565)","url":"https://doi.org/10.1200/JCO.2026.44.16_suppl.11565"}],"tags":["gap-fill","owner-request"],"related":[],"cancers":["sarcoma","osteosarcoma","pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":["top2a"],"drugs":["doxorubicin"],"companies":["gemini-therapeutics","immunitybio"],"institutions":[],"pathways":[],"terms":[],"trials":["aldoxorubicin-phase-3-sts"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"modality":"Albumin-binding small-molecule prodrug of doxorubicin, intravenous","mechanism":"Doxorubicin joined through an acid-sensitive hydrazone linker to a maleimide that bonds covalently to circulating albumin within minutes of injection; albumin carries the drug into tumours, where the acidic microenvironment and lysosomes cleave the linker and release doxorubicin, keeping free doxorubicin in the blood and heart low.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/aldoxorubicin/","neighbours":{"cancer":[{"id":"osteosarcoma","kind":"cancer","name":"Osteosarcoma","route":"/cancers/osteosarcoma/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"target":[{"id":"top2a","kind":"target","name":"Topoisomerase II alpha (TOP2A)","route":"/targets/top2a/"}],"drug":[{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"}],"company":[{"id":"gemini-therapeutics","kind":"company","name":"Gemini Therapeutics","route":"/companies/gemini-therapeutics/"},{"id":"immunitybio","kind":"company","name":"ImmunityBio","route":"/companies/immunitybio/"}],"trial":[{"id":"aldoxorubicin-phase-3-sts","kind":"trial","name":"Aldoxorubicin versus investigator's choice in relapsed or refractory soft tissue sarcoma","route":"/trials/aldoxorubicin-phase-3-sts/"},{"id":"nct04390399","kind":"trial","name":"Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer","route":"/trials/nct04390399/"}],"institution":[{"id":"sarcoma-oncology-center","kind":"institution","name":"Sarcoma Oncology Center","route":"/institutions/sarcoma-oncology-center/"}]}}