NCT02994498

Safety and Efficacy of DCB-BO1301 in Advanced Melanoma

An Open-Label Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of DCB-BO1301 as Add-on Therapy to Dacarbazine in Subjects With Advanced Melanoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Chung Mei Biopharma Co., Ltd · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary study objectives are 1. to evaluate the safety and tolerability profiles of DCB-BO1301 and to determine the maximum tolerated dose (MTD) of DCB-BO1301 as add-on therapy to dacarbazine in subjects with advanced melanoma (Phase I) 2. to evaluate the efficacy profile of DCB-BO1301 at MTD or lower dose level as add-on therapy to dacarbazine in subjects with advanced melanoma in terms of progression free survival (Phase IIa)

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	DCB-BO1301	1, 2, or 3 capsules, three times a day, oral, at most 48 weeks

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2016-12-16
• Last updated: 2022-03-18

Regulatory

• FDA-regulated drug study