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Clinical trialNCT00455052CompletedPhase 1Interventional

A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors

SponsorMersana TherapeuticsEnrollment30Non-small Cell Lung CancerSmall Cell Lung Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This amended expansion phase of the protocol is to further the experience at a dose level of 150 mg CPT eq/m2 in patients with Stage IV non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) and to test for preliminary anti-tumor activity in these tumor types. The MTD was initially defined as 113 mg CPT equivalents(eq)/m2 in the dose escalation part of the study. However, in the initial expansion phase (Protocol Amendment 11), 11 patients (10 NSCLC patients and 1 gastric cancer patients) were dosed at 113 mg CPT eq/m2 and less bone marrow toxicity was observed as compared to more heavily pre-treated patients in the dose escalation part of the study. Therefore, this amended expansion phase will investigate the safety and anti-tumor effects of a dose of 150 mg CPT eq/m2. The study will also determine: * The safety and tolerability of XMT-1001 at 150 mg CPT eq/m2 * The pharmacokinetics (PK) of XMT-1001 (how XMT-1001 behaves in the body) in patients Stage IV non-small cell lung carcinoma (NSCLC) and small cell lung cancer * Evidence of XMT-1001 anti-tumor activity at 150 mg CPT eq/m2

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Tgen Clinical Research Services at Scottsdale Healthcare

    Scottsdale, Arizona, United States

  • Rocky Mountain Cancer Centers

    Denver, Colorado, United States

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, United States

  • University of Maryland, Greenebaum Cancer Center

    Baltimore, Maryland, United States

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, United States

  • New York Oncology Hematology

    New York, New York, United States

  • Willamette Valley Cancer Institute and Research Center

    Springfield, Oregon, United States

  • Institute of Translational Oncology Research

    Greenville, South Carolina, United States

  • Texas Oncology - Tyler

    Tyler, Texas, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, United States

  • Evergreen Hematology & Oncology

    Spokane, Washington, United States

  • Vancouver Cancer Center

    Vancouver, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

XMT-1001
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Mar 2011
Primary completion
31 Dec 2011
Completion
31 Dec 2011
Last update posted
31 Jan 2018
Registered enrollment
30
Registry id
NCT00455052

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.