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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
433 enrolled.
Registry results section: medians with 95% CI 2.79-4.83 vs 2.63-4.17; no hazard ratio posted and no primary publication found
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Aldoxorubicin | 218 | 4.04 months | - | - | link |
| Investigator's choice of treatment | 215 | 2.96 months |
Shares Ifosfamide and the tag owner-request.
Shares Doxorubicin and the tag owner-request.
Shares Cytotoxic chemotherapy and the tag owner-request.
Shares Aldoxorubicin, ImmunityBio, Gemcitabine.
Shares Ifosfamide, Doxorubicin, Sarcomas (soft tissue, bone, GIST), Cytotoxic chemotherapy.
Shares ImmunityBio, Docetaxel, Cytotoxic chemotherapy.
Shares ImmunityBio, Gemcitabine, Cytotoxic chemotherapy.
Shares Ifosfamide, Doxorubicin, Sarcomas (soft tissue, bone, GIST), Cytotoxic chemotherapy.