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

Active:	No
Cancer Type:	Gynecologic Cancers Lung Cancer Ovarian Cancer Primary Peritoneal Cancer Solid Tumor	NCT ID:	NCT03319628
Trial Phases:	Phase I Phase II	Protocol IDs:	XMT-1536-1 (primary) NCI-2018-00402
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Mersana Therapeutics
NCI Full Details:	http://clinicaltrials.gov/show/NCT03319628

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.

Objectives

This is a multi-center study of XMT-1536 (upifitamab rilsodotin) in patients with tumors
likely to express NaPi2b, focusing on patients with platinum-resistant ovarian cancer and
non-small cell lung cancer, adenocarcinoma subtype. XMT-1536 (upifitamab rilsodotin) was
administered as an intravenous infusion once every four weeks. The study consisted of three
segments: dose escalation (DES), dose expansion (EXP), and the pivotal cohort (UPLIFT). The
DES segment studied small groups of patients who received increased doses. A Safety Review
Committee was established to review the data from each dose level before moving to the next
higher dose. The dose escalation cohort has ended and is no longer enrolling patients.
Enrollment into the EXP segment consisted of 2 parallel cohorts of patients to confirm the
dose that has been identified in DES and estimate the objective response rate in each patient
population. The EXP and UPLIFT cohorts are no longer enrolling patients. All adverse events
were graded according to the National Cancer Institute (NCI) Common Terminology Criteria
version (CTCAE v5.0). Throughout the study, pharmacokinetics were measured using proprietary
assays developed by Mersana. Anti-cancer activity were measured via RECIST.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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