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NCT03573544 · ClinicalTrials.gov registry record · Phase 1

This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

A Phase 1 study, sponsored by OBI Pharma.

Terminated
Registry status
Phase 1
Development phase
54
Enrollment target

NCT03573544: Clinical Trial Phase 1 study, sponsored by OBI Pharma.

NCT03573544 is a Phase 1 study that was terminated before completion, run by OBI Pharma. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03573544, a Phase 1 study, was terminated before completion, sponsored by OBI Pharma.

TERMINATED
Registry status
Phase 1
Development phase
54 participants
Enrollment target

Study Summary

The purpose of this study is to establish the maximum tolerated dose (MTD) of OBI-888 as monotherapy. And to characterize the safety and preliminary clinical activity profile of the MTD dose of OBI-888 administered as monotherapy in patients with locally advanced or metastatic solid tumors.

Primary Outcome

Assessment of OBI-888 clinical benefit rate for dose escalation and cohort expansion phases of the OBI-888-001 study.

Interventions

  • DEVICE Globo H IHC Assay
  • DRUG OBI-888

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2018-05-07
Est. Completion 2022-04-07
Phase Phase 1
OBI Pharma

7 total trials

Why NCT03573544 stopped before completion

NCT03573544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).

The record links to 0 conditions, and to 2 interventions - of which Globo H IHC Assay is the first listed.

NCT03573544 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03573544 about?

NCT03573544 is a clinical study titled "This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.". The purpose of this study is to establish the maximum tolerated dose (MTD) of OBI-888 as monotherapy. And to characterize the safety and preliminary clinical activity profile of the MTD dose of OBI-888 administered as monotherapy in patients with locally advanced or metastatic solid tumors.

What is the current status of trial NCT03573544?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2018-05-07. Estimated completion is 2022-04-07.

What interventions are being tested in trial NCT03573544?

The interventions under investigation include: Globo H IHC Assay (DEVICE), OBI-888 (DRUG).

Who is sponsoring clinical trial NCT03573544?

This trial is sponsored by OBI Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03573544's enrollment target sits among peer trials

54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03573544, the US trial registry maintained by the National Library of Medicine. NCT03573544 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.