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

Official Title

A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients With Solid Tumours Likely to Express NaPi2b


First-in-human, Phase 1b safety study of the antibody-drug conjugate (ADC) XMT-1536 administered as an intravenous infusion once every four weeks. Patients with tumour 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. In addition to safety assessments, the pharmacokinetics of the drug will be assessed along with ADC activity.

Trial Description

Primary Outcome:

  • Maximum tolerated dose or recommended Phase 2 dose
Secondary Outcome:
  • Time of maximum observed concentration of XMT-1536
  • Maximum concentration of XMT-1536
  • Area under the concentration curve of the last measurable concentration of XMT-1522
  • Antineoplastic effects of XMT-1536
  • Anti-drug antibody and neutralizing antibody
This is a multi-centre study of XMT-1536 in patients with tumours likely to express NaPi2b, focusing on patients with platinum-resistant ovarian cancer and non-small cell lung cancer, adenocarcinoma subtype. XMT-1536 will be administered as an intravenous infusion once every four weeks. The study consists of two segments: dose escalation (DES) and expansion (EXP). The DES segment studies small groups of patients who receive increased doses. A Safety Review Committee has been established to review the data from each dose level before moving to the next higher dose. Dose escalation will stop when a patient or patients experience 2 or more dose-limiting events. Enrollment into the EXP segment consists 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. All adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v4.03). Throughout the study, pharmacokinetics will be measured using proprietary assays developed by Mersana. Anti-cancer activity will be measured via RECIST.

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