drugset / Trial / NCT06517433

First-in-Human Dose Escalation Study of XMT-1536 in Cancers Likely to Express NaPi2b

NCT06517433 ↗

Phase 1 Completed 62 enrolled Mersana Therapeutics
Non-randomizedParallel-groupOpen-labelTreatment

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. In addition to safety assessments, the pharmacokinetics of the drug were assessed along with ADC activity.

Timeline

Start
2017-12-12
Primary completion
2021-07-09
Completion
2021-07-09

Drugs

EvaluationDrugModalityDoseRoute
Subject upifitamab rilsodotin Other / unclassified — Intravenous