4 results
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…
- To establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in NGM/EE Schaffhausen tablets compared with the same hormones in NGM/EE Manati tablets.- To assess the safety and tolerability of both…
Primary objective* To investigate the plasma pharmacokinetics of the first metabolite of dimethyl fumarate (DMF) - monomethyl fumarate (MMF) - following administration of the delayed- and slow-release FP187-V2B tablet formulation after single dose…