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NCT02386501 · ClinicalTrials.gov registry record · Phase 1

Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors

A Phase 1 study, sponsored by Advaxis.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT02386501: Completed Phase 1 study, sponsored by Advaxis.

NCT02386501 is a Phase 1 study that has completed, run by Advaxis. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02386501, a Phase 1 study, has completed, sponsored by Advaxis.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

This is a Phase 1b, multicenter, open-label, dose-escalation study designed to estimate the maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D) of ADXS31-164. Once the RP2D has been selected, up to 4 expansion cohorts will be evaluated.

Interventions

  • DRUG ADXS31-164

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2015-09
Est. Completion 2018-09
Phase Phase 1

Sponsor

Advaxis

9 total trials

What the Registry Record Tells You About NCT02386501

The ClinicalTrials.gov registry entry for NCT02386501 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advaxis, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which ADXS31-164 is the first listed.

NCT02386501 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02386501 about?

NCT02386501 is a clinical study titled "Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors". This is a Phase 1b, multicenter, open-label, dose-escalation study designed to estimate the maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D) of ADXS31-164. Once the RP2D has been selected, up to 4 expansion cohorts will be evaluated.

What is the current status of trial NCT02386501?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2015-09. Estimated completion is 2018-09.

What interventions are being tested in trial NCT02386501?

The interventions under investigation include: ADXS31-164 (DRUG).

Who is sponsoring clinical trial NCT02386501?

This trial is sponsored by Advaxis, which has 9 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.