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

NCT03573544 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-02-22

Study results available
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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.

Conditions

  • Metastatic Solid Tumors
  • Locally Advanced Solid Tumors

Interventions

DRUG

OBI-888

For the dose-escalation phase, OBI-888 will be given weekly at the dose levels of 5, 10, and 20 mg/kg.

DRUG

OBI-888

For the dose-expansion phase, OBI-888 will be given weekly at 20 mg/kg dose level.

DEVICE

Globo H IHC Assay

This assay will be used to identify eligible patients who may clinically benefit from the OBI-888 treatment, defined by Globo H expression.

Sponsors & Collaborators

  • OBI Pharma, Inc

    lead INDUSTRY

Principal Investigators

  • Apostolia Tsimberidou, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2022-04-07
Completion
2022-04-07
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03573544 on ClinicalTrials.gov