NCT04084366

Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors

A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (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) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of OBI-999 in patients with advanced solid tumors.

Conditions

• Locally Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	OBI-999	For the dose-escalation phase, OBI-999 will be administered on Day 1 of each 21-day cycle, for up to 35 cycles.
DRUG	OBI-999	For the dose-expansion phase, OBI-999 will be administered on Day 1 of each 21-day cycle, for up to 35 cycles.

Timeline

• Start date: 2019-11-25
• Primary completion: 2023-10-27
• Completion: 2023-10-27
• First posted: 2019-09-10
• Last updated: 2025-03-26
• Results posted: 2025-03-26

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study