NCT03573544

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

A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: OBI Pharma, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-05-07
• Primary completion: 2022-04-07
• Completion: 2022-04-07
• First posted: 2018-06-29
• Last updated: 2024-02-22
• Results posted: 2024-02-22

Locations

9 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study
• FDA-regulated device study