Summary
First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536
(upifitamab rilsodotin) administered as an intravenous infusion once every four weeks.
Patients with tumor types likely to express NaPi2b were enrolled in dose escalation.
Patients with platinum-resistant ovarian cancer and non-small cell lung cancer
(adenocarcinoma subtype) were enrolled in the expansion segment of this study. Patients
with platinum-resistant, high-grade serous ovarian cancer were enrolled in the UPLIFT
segment of this study. In addition to safety assessments, the pharmacokinetics of the
drug were assessed along with ADC activity. A QTc sub-study was added for the UPLIFT
cohort for a sub-set of sites.