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A phase Ib, multi-center, open-label, dose-escalation study of PIM447 in combination with ruxolitinib (INC424) and LEE011 administered orally in patients with myelofibrosis (CPIM447X2104C)

Primary: To estimate the MTD and/or RDE for each of the following three treatment arms in patients with myelofibrosis.* PIM447 plus ruxolitinib (doublet)* Ribociclib (LEE011) plus ruxolitinib (doublet)* PIM447 plus ruxolitinib and Ribociclib (LEE011…

A phase I, multicenter, open-label dose escalation and expansion study of LOP628, administered intravenously in adult patients with cKit-positive tumors and acute myeloid leukemia

Primary objective: To estimate the MTD/RDE of LOP628 in solid tumors and AML, respectively.Secondary objectivesL:- To characterize the safety and tolerability of LOP628- To characterize the pharmacokinetic profile of LOP628- To assess emergence of…

A phase I/II multicenter, open label study of TKI258 administered orally on an intermittent schedule in adult patients with advanced or metastatic Renal Cell Cancer (RCC)

The purpose of this phase I/II is to characterize the safety, tolerability, preliminary activity, pharmacokinetic (PK) and pharmacodynamics (PD) profile of TKI258 administered orally on a 5 days on/2 days off dosing schedule in adult patients with…

A phase Ib multi-center, open-label, 4-arm dose-escalation study of oral BEZ235 and BKM120 in combination with weekly paclitaxel in patients with advanced solid tumors and weekly paclitaxel/trastuzumab in patients with HER2+ metastatic breast cancer.

Primary:Dual-agent dose escalation part (Part 1):• To determine the maximum tolerated dose of oral, daily (qd) BEZ235 in combination with paclitaxel, qw in patients with advanced solid tumors(MTD1, Arm 1).• To determine the maximum tolerated dose of…

A phase I/II, multicenter, open-label study of MAK683 in adult patients with advanced malignancies

Primary: Part 1: Safety and tolerability. Determine the MTD and/or RP2D of MAK683.Part 2: Anti-tumor activity of MAK683.Secondary: Part 1: Anti-tumor activity. Pharmacodynamics (PD). Pharmacokinetics (PK).Part 2: Safety and tolerability. PK, PD.

A phase I, open-label, multi-center, dose escalation study of oral BGJ398, a pan FGF-R kinase inhibitor, in adult patients with advanced solid malignancies

Primary: To determine the maximum tolerated dose (MTD) and thus the recommended phase IIdose and schedule of single agent oral BGJ398 in patients with advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation.Secundary objectives* to…

A phase Ib/II multi-center, open label, dose escalation study of WNT974, LGX818 and cetuximab in patients with BRAFV600-mutant KRAS wild-type metastatic colorectal cancer harboring Wnt pathway mutations

Primary: Phase Ib: To estimate the MTD(s) and/or RP2D(s) of the triple combination of WNT974, LGX818 andcetuximab in patients with BRAFV600-mutant CRC harboring Wnt pathway mutations.Phase II: To estimate the preliminary anti-tumor activity of the…

A randomized, subject and investigator blinded, placebo controlled and multi-center platform study, to assess efficacy and safety of different investigational drugs in patients with moderate to severe hidradenitis suppurativa

Secondary objectiveTo assess the safety and tolerability of the investigational treatments in patients with moderate to severe hidradenitis suppurativa (HS) by:• Number and severity of AEs • Physical examination, vital signs, safety laboratory…

Open label multicenter Phase I/II study of the safety and efficacy of PDR001 administered to patients with advanced malignancies (CPDR001X2101)

Primary: Phase 1: To estimate the RP2D and/or the MTD for PDR001.Phase II: To estimate the anti-tumor activity of PDR001.Secondary: Both phases: Safety and tolerability, PK profile, emergence of anti-PDR001 antibodies, other parameters for…

A phase I-Ib/II, open-label, multi-center study of the safety and efficacy of MBG453 as single agent and in combination with PDR001 in adult patients with advanced malignancies

Primary: Phase I: - To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. To further investigate the safety and tolerability of different doses of…

Phase 1b, multi-arm, open-label study of PDR001 and/or MBG453 in combination with decitabine in patients with acute myeloid leukemia or high risk myelodysplastic syndrome (CPDR001X2105)

Primary: To characterize the safety and tolerability of PDR001 and/or MBG453 in combination with decitabine or azacitidine in relapsed/refractory AML patients, de novo AML patients not candidates for standard induction therapy, or high risk or…

A Phase 2, multi-center, open label study of NIR178 in combination with PDR001 in patients with selected advanced solid tumors and non-Hodgkin lymphoma (CNIR178X2201)

Primary: • Part 1:To evaluate the efficacy of NIR178 and PDR001 combination in patients with selected advanced solid tumors and diffuse large B cell lymphoma (DLBCL). • Part 2: To assess the efficacy of several intermittent dosing schedules of…