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ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:
A Phase 1/2, Open Label, Dose-Escalation and Expansion Study of Oral ORIN1001 With and Without Chemotherapy in the Treatment of Subjects With Solid Tumors

Clinical Trial Summary

This study evaluates the anti-tumor effects of ORIN 1001 in patients with advanced solid tumors or relapsed refractory metastatic breast cancer (patients with progressive disease after receiving at least two lines of therapy in the advanced setting).

Clinical Trial Description

This is a first in human, Phase 1/2, open label, dose escalation and dose expansion study that consists of two stages: Phase 1: A dose escalation stage to determine the MTD/RP2D of ORIN1001 when given as a single agent in up to 30 subjects with advanced solid tumors. In addition, a dose escalation stage to determine the MTD/RP2D of daily ORIN1001 in combination with Abraxane given intravenously in up to 18 subjects with relapsed refractory metastatic breast cancer (TNBC or ER+ HER2-). Phase 2: An expansion stage of ORIN1001 alone (Cohort A: TNBC) and in combination with Abraxane (Cohort B: Myc+; Cohort C: ER+ HER2-, and Cohort D: TNBC) to estimate efficacy in up to 120 subjects with relapsed refractory metastatic breast cancer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03950570
Study type Interventional
Source Orinove, Inc.
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date May 25, 2019
Completion date December 30, 2024
View Details
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