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
winshipcancer.emory.edu

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