OMT-111 for Terminal Stage Solid Tumors

Breast Cancer Clinical Trial

Official title: A Multi-site, Single Arm, Phase II Clinical Trial, to Evaluate the Efficacy of OMT-111 in Supporting the Treatment of Terminal Stage Solid Tumors

Status Not yet recruiting

Clinical Trial Summary

Patients with terminal stage of metastatic non-small cell lung cancer, metastatic triple negative breast cancer, or advanced or metastatic pancreatic adenocarcinoma resisting to standard therapies.

Clinical Trial Description

This is a multi-site, single arm, Phase II study designed to explore the efficacy of OMT-111 in patients with terminal stage solid tumors resistant to standard therapies.

Subjects who voluntarily provide written consent to participate in this study undergo screening tests within 4 weeks prior to the first dose of investigational product. Those who meet the inclusion/exclusion criteria are enrolled in the study.

1 cycle consists of 4 weeks (28 days). Each week consists of 5 days of treatment and 2 days of treatment-free interval (20 days of treatment and 8 days of treatment-free interval per cycle in total). This study is planned to enroll approximately 76 subjects including 42 subjects with lung cancer, 22 subjects with breast cancer, and 12 subjects with pancreatic cancer. Treatment will be provided for 12 cycles (48 weeks). During the study, tests and procedures to evaluate the efficacy and safety will be carried out according to the planned schedule. ;

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Pancreatic Cancer

• NCT number: NCT04520386
• Study type: Interventional
• Source: MetiMedi Pharmaceuticals
• Contact: DongChul Kim
• Phone: 84-93-510-7310
• Email: dongchool.kim@bigleapresearch.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2020
• Completion date: October 2022