Clinical Trials
Sponsor:
Sponsor Study ID:
Study Title:
A Phase 1b/2, First in Human, Dose Escalation and Expansion Study of XMT 1536 In Patients with Solid Tumors Likely to Express NaPi2b
NCT Number:
NCT03319628
Phase:
I
Protocol Type:
Treatment
Age Group:
Adults
Disease Sites:
Ovary, Other Female Genital, Cervix Uteri
Study Objectives:
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.
Study Documents
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