CompletedPhase 1NCT02952729

Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2

This Phase 1b trial is an open label, multi-center study of XMT-1522 administered as an intravenous infusion once every three weeks. The dose escalation part of the study will establish the maximum tolerated dose or recommended Phase 2 dose for in patients with advanced breast cancer and either a HER2 immunohistochemistry (IHC) score of at least 1+ using a validated IHC assay or with evidence of HER2 amplification. Patients with HER2 positive (by IHC or amplification) gastric cancer or nonsmall cell lung cancer may also be eligible for participation in dose escalation. Upon completion of dose escalation, the cohort expansion segment of the study will consist of four parallel cohorts of different patients groups to confirm the maximum tolerated dose or the recommended Phase 2 dose and estimate the objective response in each of the patient populations.

Checked against the public recordLast updated Feb 24, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations5
SponsorMersana Therapeutics
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Mersana Therapeutics
Interventions being studied
Drug: XMT-1522
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
03
Public criteria

Who may be able to participate

Inclusion Criteria: * Able and willing to give informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Measurable disease via RECIST * Resolution of all toxic side effects from prior oncology treatments * Adequate organ function as measured by various blood parameters * Not pregnant or lactating, willing to prevent pregnancy while on study and for 6 months after the last dose of XMT-1522 * Histologically or cytologically confirmed adenocarcinoma of the breast with unresectable locally advanced disease, or metastatic disease and HER2 IHC 1+ or 2+ OR * Histologically or cytologically confirmed adenocarcinoma of the breast with unresectable locally advanced disease, or metastatic disease and HER2 IHC 3+ or positive for HER2 gene amplification * Progressed following all standard of care therapies for advanced breast cancer. OR * Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and HER2 IHC 3+ or positive for HER2 gene amplification OR * Histologically or cytologically confirmed Stage IIIb or IV non-small cell lung cancer HER2 IHC 2+ or 3+ by local laboratory assessment. Exclusion Criteria: * Major surgery, radiation therapy, or systemic anti-cancer therapy within 28 days of starting study treatment. * Some types of brain metastases * Peripheral neuropathy of Grade 2 within 3 weeks prior to the first study therapy * History of exposure to cumulative doxorubicin dose ≥ 360 mg/meter squared. If another anthracycline or more than one anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg/meter squared of doxorubicin * History of clinically significant cardiac dysfunction * Current known active infection with HIV, hepatitis B virus, or hepatitis C virus * Current severe, uncontrolled systemic disease * Severe dyspnea at rest, due to complications of advanced malignancy, or requiring supplementary oxygen therapy. * History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome Patients who participate in the dose escalation segment of the study cannot participate in the expansion segment of the study.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Moffitt Cancer CenterTampa, Florida
  • Massachusetts General HospitalBoston, Massachusetts
  • Sarah Cannon Research InstituteNashville, Tennessee
  • Mary Crowley Cancer Research CenterDallas, Texas
  • South Texas Accelerated Research Therapeutics (START)San Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 24, 2021. Always confirm current availability with the study team.

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