drugset / Trial / NCT02994498

Safety and Efficacy of DCB-BO1301 in Advanced Melanoma

NCT02994498 ↗

Phase 1/2 Unknown 33 enrolled Chung Mei Biopharma Co., Ltd
RandomizedParallel-groupDouble-blindTreatment

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)

Timeline

Start
2023-03
Primary completion
2025-09
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject DCB-BO1301 Unknown — Oral

Indications