4 results
Primary ObjectiveSafety Lead-in* Evaluate the safety of a high-dose regimen of encorafenib + binimetinib combination therapy in patients with BRAFV600-mutant melanoma who have asymptomatic brain metastasisPhase 2If the high-dose regimen is…
Phase 1b Dose Escalation Objectives • To determine the safety and tolerability of escalating doses of GB5121• To determine the optimal biological dose (OBD) and/or maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of GB5121 Phase 1b…
Primary Objectives: Safety Assessments: Effect of Administration of Relacorilant on: • Incidence of TEAEs (assessed monthly): TEAEs, SAEs, treatment-related TEAEs, TEAEs leading to early discontinuation of study treatment• Clinical laboratory tests…
Primary • To assess the efficacy of relacorilant for the treatment of endogenous Cushing syndrome based on BP control at Week 12 of the Randomized- Withdrawal (RW) phase compared with placebo• To assess the safety of relacorilant for the treatment…