First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
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) are being enrolled in the expansion segment of this study. Patients with
platinum-resistant, high-grade serous ovarian cancer are being enrolled in the UPLIFT segment
of this study. In addition to safety assessments, the pharmacokinetics of the drug will be
assessed along with ADC activity. A QTc sub-study has been added for the UPLIFT cohort for a
sub-set of sites.