12 results
The trial is designed as an open-label pilot study. The main goal is to investigate if bezafibrate can reduce VLCFA in vivo in patient with X-ALD. If there is indeed a biochemical effect, a large follow-up study will be initiated with clinical…
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…
Sub-study APhase 1b:To assess the DLT rate and estimate the MTD of sasanlimab in combination with encorafenib and binimetinib to determine the RP2D for the combination. Phase 2:To assess the durable ORR of sasanlimab in combination with encorafenib…
Primary:- To evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the confirmed overall response rate (cORR) by local radiologist/investigator assessment in adult subjects with previously…
To characterize the safety and tolerability.1. To describe the available RFS data by treatment arm.2. To describe the available DMFS data by treatment arm.3. To describe-reported health-related quality of life (HRQoL) bytreatment arm.
Encorafenib/binimetinb combination therapy can possibly reduce tumor size and thus making surgical treatment less comprehensive. In addition, the treatment can potentially improve recurrence-free survival, overall survival, and distant metastases-…
Primary Objective: Phase I dose escalationThe main objective of the phase I part is to determine safety and the recommended phase II dose (RP2D) of the triple combination.Phase IIThe main objective of the phase II part is to determine efficacy of…
- To monitor the safety and tolerability of binimetinib- To monitor the safety and tolerability of encorafenib
Primary Objective:To evaluate the efficacy of encorafenib + binimetinib in treatment-naïve and previously treated patients with BRAFV600E-mutant NSCLC as measured by ORR.Secondary objectives:1. To evaluate the efficacy of encorafenib + binimetinib…
The primary objective is to assess the effects of the combination of OCA and BZF on alkaline phosphatase(ALP) in comparison to BZF alone in subjects with primary biliary cholangitis (PBC)To assess the effects of the combination of OCA and BZF in…
The main purpose of this study is to assess investigate the effect of encorafenib and binimetinib (the study drugs) on the activity of other common drugs and the effect of modafinil on the activity of encorafenib. The study will also look at the…
Part A1(KIN-2787 Monotherapy Escalation):Determine safety and tolerability of PO administration of Kin-2787 including DLT in participants with BRAFmutation-positive advanced or metastatic solid tumors or melanoma harboring NRAS-mutation. Identify…