Aldoxorubicin versus investigator's choice in relapsed or refractory soft tissue sarcoma
The phase 3 that was meant to bring the tumour-targeted doxorubicin aldoxorubicin to market: it did not meet its primary endpoint of progression-free survival.
Overview
433 patients with previously treated soft tissue sarcoma were randomised to aldoxorubicin or one of five investigator-chosen standard treatments. The trial did not meet its primary endpoint of progression-free survival by blinded central review, as the sponsor announced in 2016, although secondary analyses reported by the sponsor favoured aldoxorubicin in leiomyosarcoma and liposarcoma and in the primary analysis by investigator assessment. CytRx licensed the drug to ImmunityBio in 2017, and Gemini Therapeutics is now pursuing its development with integrated analyses of the randomised sarcoma studies presented at ASCO 2026.
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