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NCT03319628 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b
A Phase 1 study of Platinum-resistant Ovarian Cancer and Non Small Cell Lung Cancer Metastatic, sponsored by Mersana Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 523
- Enrollment target
- 1
- Study location
NCT03319628: Active Phase 1 study of Platinum-resistant Ovarian Cancer and Non Small Cell Lung Cancer Metastatic, sponsored by Mersana Therapeutics.
NCT03319628 is a Phase 1 study of Platinum-resistant Ovarian Cancer and Non Small Cell Lung Cancer Metastatic that is active but no longer recruiting, run by Mersana Therapeutics. The registered enrollment target is 523 participants, above the 155-participant average among 17 other Platinum-resistant Ovarian Cancer trials with a reported enrollment target (237% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03319628, a Phase 1 study of Platinum-resistant Ovarian Cancer and Non Small Cell Lung Cancer Metastatic, is active but no longer recruiting, sponsored by Mersana Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 523 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Evaluate adverse events and concomitant medication use after XMT-1536 (upifitamab rilsodotin) doses
Conditions Studied
Interventions
- DRUG upifitamab rilsodotin
Study Locations (1)
Oklahoma
- University of Oklahoma - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 523 participants |
| Start Date | 2017-12-12 |
| Est. Completion | 2024-10-31 |
| Phase | Phase 1 |
What the registry record for NCT03319628 still lists
NCT03319628 is an interventional study that assigns participants to a tested intervention. The registered 523 participants enrollment target is mid-sized for trials with a published cap, above the 155-participant average among 17 other Platinum-resistant Ovarian Cancer trials with a reported enrollment target (237% higher).
The record links to 2 conditions, with Platinum-resistant Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which upifitamab rilsodotin is the first listed.
NCT03319628 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT03319628 about?
NCT03319628 is a clinical study titled "First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b". 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 c...
What is the current status of trial NCT03319628?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 523 participants. The study started on 2017-12-12. Estimated completion is 2024-10-31.
What conditions does trial NCT03319628 study?
This clinical trial studies the following conditions: Platinum-resistant Ovarian Cancer, Non Small Cell Lung Cancer Metastatic.
What interventions are being tested in trial NCT03319628?
The interventions under investigation include: upifitamab rilsodotin (DRUG).
Who is sponsoring clinical trial NCT03319628?
This trial is sponsored by Mersana Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03319628 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03319628's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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