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NCT02952729 · ClinicalTrials.gov registry record · Phase 1
Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2
A Phase 1 study, sponsored by Mersana Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT02952729 is a Phase 1 study that has completed, run by Mersana Therapeutics. The registered enrollment target is 120 participants.
The verdict
NCT02952729, a Phase 1 study, has completed, sponsored by Mersana Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG XMT-1522
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2016-11-21 |
| Est. Completion | 2019-01-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02952729
The ClinicalTrials.gov registry entry for NCT02952729 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mersana Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which XMT-1522 is the first listed.
NCT02952729 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02952729 about?
NCT02952729 is a clinical study titled "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 HE...
What is the current status of trial NCT02952729?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2016-11-21. Estimated completion is 2019-01-28.
What interventions are being tested in trial NCT02952729?
The interventions under investigation include: XMT-1522 (DRUG).
Who is sponsoring clinical trial NCT02952729?
This trial is sponsored by Mersana Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
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