5 results
Part I (dose-escalation): to evaluate the safety of SYD985 and to determine the Maximum Tolerated Dose and Recommended Phase 2 DosePart II (expanded cohorts): to evaluate the Objective tumour Response Rate
To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight plus budesonide (9mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. To study safety and…
Phase 1 Dose Escalation:Phase 1 Dose Escalation has been completed as of Amendment 6Phase 1 Expansion Primary• To evaluate ORR in cholangiocarcinoma (intra-hepatic [iCCA] or extra-hepatic [eCCA]) patients with tumors harboring FGFR2 gene fusions or…
Cohorts A nd B :The primary objective is to evaluate the objective response rate (ORR) in patients with solid tumors harboring FGFRrearrangements or gastric cancer (including GEJ cancer) harboring FGFR2 amplifications based on independent central…
The primary objective of this study is to demonstrate that SYD985 is superior to physician*s choice in prolonging progression-free survival (PFS) on the basis of the blinded independent central review of tumour assessment.The secondary objectives of…