Primary Outcome Measures
Number of participants with Adverse Events (AEs) as a measure of safety and tolerability [Time Frame: up to 5 years] [Designated as safety issue: ]
Dose limiting toxicities (DLTs) (dose escalation only) [Time Frame: up to 3 years] [Designated as safety issue: ]
Tolerability measured by the number of subjects who have interruptions/reductions of study treatment and reason for interruptions/reductions [Time Frame: up to 5 years] [Designated as safety issue: ]
Tolerability measured by the dose intensity of study drug, Relative Dose intensity for subjects with non-zero duration of exposure is computed as the ratio of dose intensity and planned dose intentity [Time Frame: Up to 5 years] [Designated as safety issue: ]
Secondary Outcome Measures
Overall Response Rate (ORR) [Time Frame: Up to 5 years] [Designated as safety issue: ]
Duration of response (DOR) [Time Frame: Up to 5 years] [Designated as safety issue: ]
Disease Control Rate (DCR) [Time Frame: Up to 5 years] [Designated as safety issue: ]
Progression Free Survival (PFS) [Time Frame: Up to 5 years] [Designated as safety issue: ]
Overall Survival (OS) - (dose expansion part only) [Time Frame: Up to 6 years] [Designated as safety issue: ]
Derived PK parameter (Cmax) for LXH254 & LTT462: [Time Frame: Up to 5 years] [Designated as safety issue: ]
Derived PK parameter (AUC) for LXH254 & LTT462 [Time Frame: Up to 5 years] [Designated as safety issue: ]
Changes from baseline of pharmacodynamics (PD) marker DUSP6 in tumor samples [Time Frame: up to 5 years] [Designated as safety issue: ]
Derived PK parameter (Cmax) for LXH254 & trametinib [Time Frame: up to 5 years] [Designated as safety issue: ]
Derived PK parameter (AUC) for LXH254 & trametinib [Time Frame: Up to 5 years] [Designated as safety issue: ]
Derived PK parameter (Cmax) for LXH254 & ribociclib [Time Frame: Up to 5 years] [Designated as safety issue: ]
Derived PK parameter (AUC) for LXH254 & ribociclib [Time Frame: Up to 5 years] [Designated as safety issue: ]